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| Name | Class |
|---|---|
| DeNova Research | OTHER |
| University of California, San Diego | OTHER |
| The Wall Center for Plastic Surgery | OTHER |
| Mathew Avram, MD |
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This study will investigate treatments that may mitigate bruising after QWOâ„¢ (Collagenase clostridium histolyticum [CCH]-aaes) treatment of cellulite in the buttocks.
CCH-aaes is indicated for the treatment of moderate to severe cellulite in the buttocks of adult women. Since bruising may be bothersome, this study will investigate treatments that may mitigate bruising after treatment of cellulite in the buttocks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: CCH-aaes | Active Comparator | CCH-aaes was administered without mitigation treatment (control group). |
|
| Cohort 2: CCH-aaes + Compression Garment | Active Comparator | CCH-aaes was administered with compression garment. |
|
| Cohort 3: CCH-aaes + Instant Cold Packs | Active Comparator | CCH-aaes was administered with instant cold packs. |
|
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | Active Comparator | CCH-aaes was administered with arnica gel patches (OcuMend). |
|
| Cohort 5:CCH-aaes + INhance Post-Injection Serum with TriHex Technology® | Active Comparator | CCH-aaes was administered with INhance Post-Injection Serum with TriHex Technology® |
|
| Cohort 6: CCH-aaes + Pulse Dye Laser Treatment (PDL) | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CCH-aaes | Drug | Participants were administered CCH-aaes by subcutaneous injection to both buttocks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-point photonumeric scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome. | Day 4 (3 days after CCH-aaes injection) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS) | The investigator assessed improvement of bruising using the I-BIS, a 3-point Likert scale that compares bruising on the mitigated side to the bruising on the non-mitigated side as either worse (1), the same (2), or improved (3). I-BIS Rating was directly obtained from the investigator's assessment rating comparing the bruising of the mitigation-treated buttock to the untreated (with mitigation treatment) buttock. |
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Key Inclusion Criteria:
Have both buttocks with:
Have a body mass index between ≥18 and ≤30 kilograms (kg)/square meter (m^2).
Be willing to apply sunscreen before each exposure to the sun while participating in the study (that is, Baseline through end of study).
Be judged to be in good health.
Be willing and able to cooperate with the requirements of the study.
Key Exclusion Criteria:
Has a coagulation disorder including but not limited to a Factor II, V, VII, or X deficiency.
Has local conditions in the areas to be treated (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
Has skin laxity or linear undulations on buttocks that can be effaced by lifting skin.
Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before CCH-aaes treatment.
Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
Is pregnant and/or is presently nursing or providing breast milk or plans to become pregnant during the study.
Intends to initiate an intensive sport or exercise program during the study.
Tanning or use of tanning agents.
Intends to engage in strenuous activity within 48 hours after the first injection of CCH-aaes.
Has received an investigational drug or treatment within 30 days prior to injection of CCH-aaes.
Has a history of hypersensitivity or allergy to collagenase or any other excipient of CCH-aaes.
Has a known systemic allergy or local sensitivity to any of the mitigation treatments or including excipients (that is, arnica patches, INhance Post-injection Serum).
Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH-aaes in a previous investigational study for cellulite.
For participants allocated to PDL treatment Participants will be excluded from PDL treatment if they have any contraindications to PDL a. exposure to Accutane® (isotretinoin) within 6 months of CCH-aaes treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Affairs | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endo Clinical Trial Site #3 | Scottsdale | Arizona | 85255 | United States | ||
| Endo Clinical Trial Site #2 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: CCH-aaes | Collagenase clostridium histolyticum (CCH)-aaes was administered to both buttocks without mitigation treatment (control group). |
| FG001 | Cohort 2: CCH-aaes + Compression Garment |
| 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 | May 20, 2022 | Aug 20, 2022 |
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| UNKNOWN |
| Laser & Skin Surgery Medical Group, Inc. | OTHER |
| Investigate MD, LLC | OTHER |
| Biesman, Brian, M.D. | INDIV |
| Plastic Surgical Associates of Fort Collins, P.C. | OTHER |
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CCH-aaes was administered with PDL. |
|
| Compression | Other | Participants used a compression garment on both buttocks following subcutaneous CCH-aaes injections. |
|
| Cold Packs | Other | Participants used cold packs applied to the right buttock for 5-10 minutes immediately after subcutaneous CCH-aaes injections. |
|
| Arnica Gel | Drug | Participants used Arnica Gel Patches (Arnica montana 50% and Ledum palustre) immediately after the CCH-aaes injection to the right buttock. |
|
| INhance® | Drug | Participants used INhance Post-injection Serum topically immediately after the CCH-aaes injection to the right buttock. |
|
| PDL | Other | Investigators applied one treatment with PDL to the right buttock between days 1-7 after injection. |
|
| Days 4 and 7 |
| Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS) | The investigator assessed improvement of bruising using the S-BIS, a 3-point Likert scale that compares bruising on the mitigated side to the bruising on the non-mitigated side as either worse (1), the same (2), or improved (3). S-BIS Rating was directly obtained from the participant's assessment rating comparing the bruising of the mitigation-treated buttock to the untreated (with mitigation treatment) buttock. The S-BIS assessment was not completed for participants that did not receive mitigation treatment (Cohort 1) or participants that received bilateral mitigation treatment (Cohort 2), as these participants did not have an untreated buttock as a comparator. | Days 4 and 7 |
| Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | The Patient Bother by Bruising Scale is a 4-point scale, with a score of 1 indicating not bothered at all, and a score of 4, indicating extremely bothered. A lower score indicates a better outcome. | Day 4 |
| Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 | Improvement was defined as +1 or better score on the I-GAIS for either buttock on Day 71 compared to Baseline. The I-GAIS is a 7-level scale ranging from +3 (very much improved) to -3 (very much worse). A higher score indicated a better outcome. | Day 71 |
| Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome. | Day 7 |
| The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome. | Day 14 |
| The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome. | Day 22 |
| Sacramento |
| California |
| 95816 |
| United States |
| Endo Clinical Trial Site #7 | San Diego | California | 92122 | United States |
| Endo Clinical Trial Site #6 | Fort Collins | Colorado | 80525 | United States |
| Endo Clinical Trial Site #5 | Chicago | Illinois | 60611 | United States |
| Endo Clinical Trial Site #1 | Shreveport | Louisiana | 71105 | United States |
| Endo Clinical Trial Site #8 | Boston | Massachusetts | 02114 | United States |
| Endo Clinical Trial Site #4 | Nashville | Tennessee | 37203 | United States |
CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment.
| FG002 | Cohort 3: CCH-aaes + Instant Cold Packs | CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment. |
| FG003 | Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and twice daily (BID) for 2 days as the mitigation treatment. |
| FG004 | Cohort 5: CCH-aaes + INhance Post-Injection Serum With TriHex Technology® | CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only four times daily (QID) for up to 7 days as the mitigation treatment. |
| FG005 | Cohort 6: CCH-aaes + Pulse Dye Laser Treatment (PDL) | CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes with or without mitigation treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: CCH-aaes | CCH-aaes was administered to both buttocks without mitigation treatment (control group). |
| BG001 | Cohort 2: CCH-aaes + Compression Garment | CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment. |
| BG002 | Cohort 3: CCH-aaes + Instant Cold Packs | CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment. |
| BG003 | Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment. |
| BG004 | Cohort 5:CCH-aaes + INhance Post-Injection Serum With TriHex Technology® | CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment. |
| BG005 | Cohort 6: CCH-aaes + PDL | CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Fitzpatrick Skin Rating | Number | units on a scale |
|
| 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 | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 | Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-point photonumeric scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome. | Evaluable Population: All participants allocated to treatment who receive at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes. | Posted | Count of Participants | Participants | Day 4 (3 days after CCH-aaes injection) |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS) | The investigator assessed improvement of bruising using the I-BIS, a 3-point Likert scale that compares bruising on the mitigated side to the bruising on the non-mitigated side as either worse (1), the same (2), or improved (3). I-BIS Rating was directly obtained from the investigator's assessment rating comparing the bruising of the mitigation-treated buttock to the untreated (with mitigation treatment) buttock. | Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes. The I-BIS assessment was not completed for participants that did not receive mitigation treatment (Cohort 1) or participants that received bilateral mitigation treatment (Cohort 2), as these participants did not have an untreated buttock as a comparator. | Posted | Count of Participants | Participants | Days 4 and 7 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS) | The investigator assessed improvement of bruising using the S-BIS, a 3-point Likert scale that compares bruising on the mitigated side to the bruising on the non-mitigated side as either worse (1), the same (2), or improved (3). S-BIS Rating was directly obtained from the participant's assessment rating comparing the bruising of the mitigation-treated buttock to the untreated (with mitigation treatment) buttock. The S-BIS assessment was not completed for participants that did not receive mitigation treatment (Cohort 1) or participants that received bilateral mitigation treatment (Cohort 2), as these participants did not have an untreated buttock as a comparator. | Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes. The S-BIS assessment was not completed for participants that did not receive mitigation treatment (Cohort 1) or participants that received bilateral mitigation treatment (Cohort 2), as these participants did not have an untreated buttock as a comparator. | Posted | Count of Participants | Participants | Days 4 and 7 |
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| Secondary | Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 | The Patient Bother by Bruising Scale is a 4-point scale, with a score of 1 indicating not bothered at all, and a score of 4, indicating extremely bothered. A lower score indicates a better outcome. | Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes. | Posted | Count of Participants | Participants | Day 4 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 | Improvement was defined as +1 or better score on the I-GAIS for either buttock on Day 71 compared to Baseline. The I-GAIS is a 7-level scale ranging from +3 (very much improved) to -3 (very much worse). A higher score indicated a better outcome. | Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes. | Posted | Count of Participants | Participants | Day 71 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 | Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome. | Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes. | Posted | Count of Participants | Participants | Day 7 |
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| Secondary | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 | Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome. | Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes. | Posted | Count of Participants | Participants | Day 14 |
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| Secondary | The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 | Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome. | Evaluable Population: All participants allocated to treatment who received at least 1 injection of CCH-aaes and had at least 1 bruising assessment after the first dose of CCH-aaes. | Posted | Count of Participants | Participants | Day 22 |
|
Day 1 (after dosing) through Day 71
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: CCH-aaes | CCH-aaes was administered to both buttocks without mitigation treatment (control group). | 0 | 7 | 0 | 7 | 6 | 7 |
| EG001 | Cohort 2: CCH-aaes + Compression Garment | CCH-aaes was administered to both buttocks with compression garments as the mitigation treatment. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG002 | Cohort 3:CCH-aaes + Instant Cold Packs | CCH-aaes was administered to both buttocks with instant cold packs applied to the right buttock only for 5-10 minutes post injection as the mitigation treatment. | 0 | 9 | 0 | 9 | 9 | 9 |
| EG003 | Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment. | 0 | 9 | 0 | 9 | 9 | 9 |
| EG004 | Cohort 5: CCH-aaes + INhance Post-Injection Serum With TriHex Technology® | CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG005 | Cohort 6: CCH-aaes + PDL | CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment. | 0 | 7 | 0 | 7 | 6 | 7 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site discolouration | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Endo Pharmaceuticals | 1-800-462-3636 | ClinicalTrials@Endo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2021 | Aug 20, 2022 | 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 |
|---|---|
| C003755 | Vascularin-Gel |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| II (Fair) |
|
| III (Darker White) |
|
| Right Buttock: None or almost no bruising (0) |
|
| Left Buttock (control): mild bruising (1) |
|
| Right Buttock: mild bruising (1) |
|
| Left Buttock (control): Moderate bruising (2) |
|
| Right Buttock: Moderate bruising (2) |
|
| Left Buttock (control): severe bruising (3) |
|
| Right Buttock: severe bruising (3) |
|
| Left Buttock (control): very severe bruising (4) |
|
| Right Buttock: severe bruising (4) |
|
| OG002 | Cohort 5:CCH-aaes + INhance Post-Injection Serum With TriHex Technology® | CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment. |
| OG003 | Cohort 6: CCH-aaes + PDL | CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment. |
|
|
CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment. |
| OG002 | Cohort 5: CCH-aaes + INhance Post-Injection Serum With TriHex Technology® | CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment. |
| OG003 | Cohort 6: CCH-aaes + PDL | CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment. |
|
|
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) |
CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment. |
| OG004 | Cohort 5: CCH-aaes + INhance Post-Injection Serum With TriHex Technology® | CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment. |
| OG005 | Cohort 6: CCH-aaes + PDL | CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment. |
|
|
| OG003 |
| Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) |
CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment. |
| OG004 | Cohort 5: CCH-aaes + INhance Post-Injection Serum With TriHex Technology® | CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment. |
| OG005 | Cohort 6: CCH-aaes + PDL | CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment. |
|
|
| OG003 | Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment. |
| OG004 | Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment. |
| OG005 | Cohort 6: CCH-aaes + PDL | CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment. |
|
|
| OG003 | Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment. |
| OG004 | Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment. |
| OG005 | Cohort 6: CCH-aaes + PDL | CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment. |
|
|
| OG003 | Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend) | CCH-aaes was administered to both buttocks with arnica gel patches (OcuMend) applied to the right buttock only immediately after injection and BID for 2 days as the mitigation treatment. |
| OG004 | Cohort 5: CCH-aaes + Post-Injection Serum With TriHex Technology® | CCH-aaes was administered to both buttocks with INhance Post-Injection Serum with TriHex Technology® applied to the right buttock only QID for up to 7 days as the mitigation treatment. |
| OG005 | Cohort 6: CCH-aaes + PDL | CCH-aaes was administered to both buttocks with PDL applied once to the right buttock only between Days 1-7 post injection as the mitigation treatment. |
|
|