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The study will evaluate the safety and effectiveness of different injection techniques of Collagenase Clostridium Histolyticum (CCH) for the treatment of adult women with mild, moderate or severe Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment I: CCH Shallow Injection, 3 Aliquots | Active Comparator | In Treatment I, CCH will be injected subcutaneously while the participant lies in a prone position. Each injection will consist of a single skin injection of study drug administered as three 0.1 milliliters (mL) aliquots (for a total injection volume of 0.3 mL). During each treatment visit, 8 syringes (4 syringes per treatment area) will be prepared for dosing. Each syringe will contain 0.9 mL of CCH (3 injections in each syringe). Dose per participant per treatment visit = up to 1.68 milligrams (mg) of CCH (0.84 mg in each treatment area). |
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| Treatment II: CCH Shallow Injection, 1 Aliquot | Active Comparator | In Treatment II, CCH will be injected subcutaneously while the participant is in a prone position. Each injection will consist of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. During each treatment visit, 8 syringes (4 syringes per treatment area) will be prepared for dosing. Each syringe will contain 0.9 mL of CCH (3 injections in each syringe). Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). |
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| Treatment III: CCH Deep Injection, 1 Aliquot | Active Comparator | In Treatment III, CCH will be injected subcutaneously while the participant is in a prone position. Each injection will consist of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. During each treatment visit, 8 syringes (4 syringes per treatment area) will be prepared for dosing. Each syringe will contain 0.9 mL of CCH (3 injections in each syringe). Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collagenase clostridium histolyticum (CCH) | Drug | Endo Pharmaceuticals Inc. (Endo) is developing collagenase clostridium histolyticum (CCH) for the treatment of EFP. Because CCH is a proteinase that can hydrolyze the triple-helical region of collagen under physiological conditions, CCH has the potential to be effective in lysing sub-dermal collagen, such as those observed in the dermal septa, which are the underlying cause of the skin dimpling in women with Edematous Fibrosclerotic Panniculopathy (EFP). CCH targets the collagenase structural matrix (for example, dermal septa) at the site of injection and does not require systemic exposure to be effective. |
| Measure | Description | Time Frame |
|---|---|---|
| Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22 | Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 22 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh). | Day 22 |
| Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43 | Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 43 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh). | Day 43 |
| Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71 | Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 71 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of Dimple Volume by Treatment Region | For each treated buttock and thigh, 4 dimple parameters including the maximum length (largest straight line distance across the dimple), maximum width (largest straight line distance perpendicular to the maximum length measurement), surface are, and volume (between the base of the dimple and an interpolated surface) of the target dimple were assessed. A negative change from Day 1 indicated an improvement. Volume of Dimple from Day 1 pre-marking was analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the measurement for the average of left and right of treatment areas (that is, average of left buttock posterior and right buttock posterior; average of left thigh lateral, left thigh oblique, left thigh posterior, right thigh lateral, right thigh oblique, and right thigh posterior). |
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Inclusion Criteria:
No participant will be assigned to treatment until all eligibility criteria have been satisfied. To qualify for the study a participant must:
Be able to provide voluntary written informed consent prior to the initiation of any study specific procedures per the policy of the governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
Be female and at least 18 years of age at the time of consent.
Have evidence of cellulite in 2 bilateral treatment areas (defined as right and left buttocks or right and left posterolateral thighs) as assessed by the Investigator at the Screening visit, and fulfills the following requirements:
has a score of 2 (mild), 3 (moderate) or 4 (severe) as reported by the Investigator (CR-PCSS) in 2 treatment areas (two thighs or two buttocks) at the Screening Visit.
has at least 2 dimples from each treatment area that:
Be willing to apply sunscreen to the dosing areas before each exposure to the sun while participating in the study (that is, screening through end of study).
Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening.
Have a negative serum pregnancy test at the Screening Visit and negative urine pregnancy at Day 1 (before injection of study drug), be using an effective contraception method (for example, abstinence, intrauterine device, hormonal [estrogen/progestin] contraceptives, or double barrier control) for at least 1 menstrual cycle prior to study enrollment and through Day 71; or be menopausal defined as at least 12 months of amenorrhea in the absence of other biological or physiological causes (as determined by the Investigator), or be post-menopausal for at least 1 year, or be surgically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation).
Be willing and able to comply with all protocol required study visits and assessments.
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from the study:
Is pregnant or is intending to become pregnant during the study.
Is presently nursing/breastfeeding or providing breast milk.
Has any of the following systemic conditions:
Has any of the following local conditions in the areas to be treated:
Has a tattoo located within 2 cm of the site of injection.
Requires anticoagulant or antiplatelet medication during the study or has received anticoagulant or antiplatelet medication (except for ≤ 150 mg aspirin daily) within 7 days before injection of study drug.
Has used any of the following for the treatment of EFP on the area to be treated within the timelines identified below or intends to use any of the following at any time during the course of the study:
Has received an investigational drug or treatment within 30 days before injection of study drug.
Has a known systemic allergy to collagenase or any other excipient of study drug.
Has a history of drug or alcohol abuse.
Intends to initiate an intensive sport or exercise program during the study.
Intends to initiate a weight reduction program during the study.
Intends to use tanning spray or tanning booths during the study.
Has previously received any collagenase treatments (for example, Santyl® ointment and/or XIAFLEX/XIAPEX®).
Was a participant in a previous cellulite clinical trial of EN3835: AUX-CC-830, AUX-CC-831, EN3835-102, EN3835-104, EN3835-201, EN3835-202, EN3835-205, EN3835-302, or EN3835-303.
Any other condition(s) that, in the Investigator's opinion, might indicate the participant is unsuitable for the study.
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| Name | Affiliation | Role |
|---|---|---|
| George Omburo | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endo Clinical Trial Site #1 | Coral Gables | Florida | 33146 | United States | ||
| Endo Clinical Trial Site #5 |
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Participants in each treatment region (buttocks or thighs) were assigned to 1 of 5 injection technique treatment arms. No participants were treated in both the buttocks and the thighs.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) | In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 milliliters (mL) aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 29, 2018 | Feb 25, 2021 |
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| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots | Active Comparator | In Treatment IV, CCH will be injected subcutaneously while the participant lies in a prone position. Each injection will consist of a single skin injection of study drug administered as five 0.3 mL (for a total injection volume of 1.5 mL). During each treatment visit, 24 syringes (12 syringes per treatment area) will be prepared for dosing. Each syringe will contain 1.5 mL of CCH (5 aliquots of 0.3 mL, for each injection, in each syringe). Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). |
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| Treatment V: CCH Shallow Injections, 4 Aliquots | Active Comparator | In Treatment V, CCH will be injected subcutaneously while the participant lies in a prone position. Each injection will receive a single skin injection of study drug administered as four 0.3 mL aliquots (for a total injection volume of 1.2 mL). During each treatment visit, 24 syringes (12 syringes per treatment area) will be prepared for dosing. Each syringe will contain 1.2 mL of CCH (4 aliquots of 0.3 mL each). Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). |
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| Day 71 |
| Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22 | Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh) | Baseline, Day 22 |
| Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43 | Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh) | Baseline, Day 43 |
| Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71 | Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh) | Baseline, Day 71 |
| Baseline, Day 22, Day 43, and Day 71 |
| Miami |
| Florida |
| 33137 |
| United States |
| Endo Clinical Trial Site #2 | New York | New York | 10016 | United States |
| Endo Clinical Trial Site #4 | New York | New York | 10022 | United States |
| Endo Clinical Trial Site #3 | New York | New York | 10065 | United States |
| FG001 | Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| FG002 | Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| FG003 | Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| FG004 | Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| FG005 | Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit |
| FG006 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| FG007 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| FG008 | Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| FG009 | Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
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| NOT COMPLETED |
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Safety Population includes all participants who had at least 1 injection of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) | In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| BG001 | Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| BG002 | Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| BG003 | Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| BG004 | Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| BG005 | Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| BG006 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| BG007 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| BG008 | Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| BG009 | Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kg |
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| Height | One participant did not have data collected for height. | Mean | Standard Deviation | cm |
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| Body Mass Index (BMI) | One participant did not have data collected for BMI. | Mean | Standard Deviation | kg/m^2 |
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| Skin Category (Fitzpatrick Scale) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
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| Primary | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22 | Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 22 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh). | Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance improvement Likert scale rating at specified timepoint. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Day 22 |
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| Primary | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43 | Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 43 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh). | Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance improvement Likert scale rating at specified timepoint. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Day 43 |
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| Primary | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71 | Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 71 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh). | Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance improvement Likert scale rating at specified timepoint. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Day 71 |
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| Primary | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22 | Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh) | Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance Likert scale rating at specified timepoint. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Day 22 |
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| Primary | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43 | Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh) | Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance Likert scale rating at specified timepoint. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Day 43 |
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| Primary | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71 | Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh) | Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance Likert scale rating at specified timepoint. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Day 71 |
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| Secondary | Change From Baseline of Dimple Volume by Treatment Region | For each treated buttock and thigh, 4 dimple parameters including the maximum length (largest straight line distance across the dimple), maximum width (largest straight line distance perpendicular to the maximum length measurement), surface are, and volume (between the base of the dimple and an interpolated surface) of the target dimple were assessed. A negative change from Day 1 indicated an improvement. Volume of Dimple from Day 1 pre-marking was analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the measurement for the average of left and right of treatment areas (that is, average of left buttock posterior and right buttock posterior; average of left thigh lateral, left thigh oblique, left thigh posterior, right thigh lateral, right thigh oblique, and right thigh posterior). | Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance Likert scale rating at specified timepoint. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment. | Posted | Least Squares Mean | 95% Confidence Interval | mm^3 | Baseline, Day 22, Day 43, and Day 71 |
|
Day 1 (after dosing) through Day 71
All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) | In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG001 | Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG002 | Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG003 | Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 0 | 7 | 0 | 7 | 7 | 7 |
| EG004 | Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG005 | Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG006 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG007 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 0 | 7 | 1 | 7 | 7 | 7 |
| EG008 | Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 0 | 7 | 1 | 7 | 7 | 7 |
| EG009 | Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 0 | 6 | 0 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hospitalization | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Injection site discolouration | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Influenza-like illness | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Injection site mass | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Crystal urine present | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Endo Pharmaceuticals | 800-462-3636 | clinicaltrials@endo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 11, 2019 | Feb 25, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000071697 | Cellulite |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003012 | Microbial Collagenase |
| ID | Term |
|---|---|
| D017364 | Collagenases |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
Not provided
Not provided
|
|
|
|
|
|
|
|
| II (Fair) |
|
|
| III (Darker White) |
|
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| IV (Light Brown) |
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| V (Brown) |
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| VI (Dark Brown or Black) |
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| OG005 | Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit |
| OG006 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG007 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG008 | Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG009 | Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG001 | Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG002 | Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG003 | Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG004 | Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG005 | Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit |
| OG006 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG007 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG008 | Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG009 | Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
|
|
| OG001 | Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG002 | Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG003 | Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG004 | Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG005 | Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit |
| OG006 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG007 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG008 | Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG009 | Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
|
|
| OG001 | Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG002 | Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG003 | Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG004 | Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG005 | Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit |
| OG006 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG007 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG008 | Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG009 | Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
|
|
| OG001 | Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG002 | Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG003 | Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG004 | Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG005 | Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit |
| OG006 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG007 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG008 | Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG009 | Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
|
|
| OG001 | Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG002 | Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG003 | Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG004 | Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG005 | Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit |
| OG006 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG007 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG008 | Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG009 | Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
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|
| OG001 | Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG002 | Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG003 | Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG004 | Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG005 | Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit |
| OG006 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG007 | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG008 | Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
| OG009 | Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. |
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