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This study is designed to investigate the safety and efficacy of collagenase clostridium histolyticum (CCH) for the treatment of mild to moderate edematous fibrosclerotic panniculopathy (cellulite) in participants with moderate to severe dermal laxity in the buttocks or thighs with comparison between two (2) different CCH injection techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uniform 0.1-milliliters (mL) 1-Aliquot Grid Injection Technique (Buttock) | Active Comparator | Dose per participant per treatment visit = up to 1.68 milligrams (mg) of CCH (0.84 mg in each treatment area) |
|
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttock) | Active Comparator | Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area) |
|
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thigh) | Active Comparator | Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area) |
|
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thigh) | Active Comparator | 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 | Drug | Delivered via uniform grid injection techniques. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh | I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented. | Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented. |
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Inclusion Criteria:
Have a body mass index of 18 to <29.9 kilograms/square meters
Have either both buttocks or both posterolateral thighs with:
Have a negative pregnancy test or be of non-childbearing potential
Be willing and able to cooperate with the requirements of the study
Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study (from the Screening Visit through the Day 180/Early Termination Visit).
Exclusion Criteria:
Has a history of hypersensitivity or allergy to collagenase or any other excipients of CCH.
During Screening has a CR-PCSS score of less than 2 or greater than 3 for the area to be treated (buttocks or thighs) and/or has a Hexsel CSS Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of less than 2 or greater than 3 (severe) for the areas to be treated (buttocks or thighs).
Has a coagulation disorder, which requires anticoagulant or antiplatelet medication during the study (except for ≤150 mg aspirin daily), or has taken anticoagulant or antiplatelet medication(s) within 14 days before injection of study treatment (except for ≤150 mg aspirin daily).
Is a prisoner, an individual with impaired decision making capacity, employees (temporary, part-time, full-time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC), or in the judgment of the investigator the participant is disadvantaged and vulnerable to coercion due to lack of education, or due to poor economic circumstances.
Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH in a previous investigational study for cellulite.
Is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study.
Has a history of scarring due to keloids or abnormal wound healing.
Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation
Has history of drug or alcohol abuse within the 5 years prior to the Screening Visit.
Has evidence of clinically significant abnormalities, as judged by the investigator, in any of the following: physical examination findings, electrocardiogram (ECG), clinical laboratory values, or vital signs.
The sponsor's medical monitor will be required to review the results for confirmation of eligibility in the case of any of the following: abnormalities in electrocardiograms indicating corrected QT interval (QTc) prolongation of 470 milliseconds or greater; and clinical laboratory values of liver enzymes
Has used or intends to use any of the local application/therapies/injections/procedures that restricts study participation.
Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
For the subset of participants participating in the collection of ultrasound data, the following exclusions will apply: participants will be excluded who have: a history of a spinal laminectomy, a previous history or presence of vascular abnormalities (for example, deep vein thrombosis, thrombophlebitis), a healing fracture, an impaired sensation within, or near, the planned treatment area, or any implants within, or near, the planned treatment area.
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| Name | Affiliation | Role |
|---|---|---|
| David Hernandez | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endo Clinical Trial Site #3 | Coral Gables | Florida | 33146 | United States | ||
| Endo Clinical Trial Site #2 |
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Participants were randomized to receive treatment in either a uniform 0.1-milliliter (mL), 1-aliquot, grid injection technique or uniform 0.3-mL, 2-aliquot grid injection technique in a 1:1 ratio. Each participant had 2 treatment areas (each buttock or each thigh).
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| ID | Title | Description |
|---|---|---|
| FG000 | Uniform 0.1-mL (Milliliter) 1-Aliquot Grid Injection Technique (Buttocks) | Dose per participant per treatment visit = up to 1.68 milligrams (mg) of collagenase clostridium histolyticum (CCH) (0.84 mg in each treatment area). |
| FG001 | Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) |
| 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 | Dec 3, 2020 | Aug 28, 2022 |
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|
| Days 28, 56, 84, 112, and 140 |
| Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | S-GAIS assessments were based on digital photographs, and were performed separately for each of 2 treatment areas. S-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the participant ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level S-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the S-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented. | Days 28, 56, 84, 112, 140, and 180 |
| Change From Baseline in Body-Q Appraisal of Cellulite Total Score | The Body-Q Appraisal of Cellulite is a subset of 11 questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. Total score is the sum of all 11 question scores. The minimum possible total score is 11 and the maximum possible total score is 44. Higher scores indicate the individual is less bothered by their cellulite. | Baseline, Day 180 |
| Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite using a 4-point scale from a low of 0 to high of 3: 0 (absence of laxity, flaccidity, or sagging skin), 1 (slight draped appearance), 2 (moderate draped appearance), and 3 (severe draped appearance). The investigator or qualified designee used the Hexsel CSS Subsection D to assess the severity of dermal laxity in each buttock or each thigh independently. A decrease from baseline indicated a better outcome. | Baseline, Days 28, 56, 84, 112,140, and 180 |
| Percentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies | Blood samples were collected to assess anti-clostridial class I collagenase (AUX-I) and anti-Clostridial class II collagenase (AUX-II) antibody levels. The percentage of participants who were positive for anti-AUX-I and anti-AUX-II antibodies are presented. | Day 180 |
| Percentage of Participants Positive for Neutralizing Antibodies to AUX-I and AUX-II | Blood samples were collected to assess neutralizing antibodies to AUX-I and AUX-II. The percentage of participants who were positive for neutralizing antibodies to AUX-I and AUX-II are presented. | Day 180 |
| Metairie |
| Louisiana |
| 70006 |
| United States |
| Endo Clinical Trial Site #1 | New York | New York | 10021 | United States |
Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). |
| FG002 | Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). |
| FG003 | Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population: All enrolled participants who received at least 1 injection of CCH. Participants who received injection in the buttock or thigh are combined for each injection technique.
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| ID | Title | Description |
|---|---|---|
| BG000 | Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttock or Thigh) | Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). |
| BG001 | Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttock or Thigh) | Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). |
| BG002 | 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 |
|
| 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 | Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh | I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented. | Modified Intent-to-Treat (mITT) Population: All enrolled participants who received at least 1 injection of CCH and who had at least 1 valid I-GAIS evaluation after the injection of CCH. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 180 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented. | mITT Population: All enrolled participants who received at least 1 injection of CCH and who had at least 1 valid I-GAIS evaluation after the injection of CCH. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 28, 56, 84, 112, and 140 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | S-GAIS assessments were based on digital photographs, and were performed separately for each of 2 treatment areas. S-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the participant ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level S-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the S-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented. | mITT Population: All enrolled participants who received at least 1 injection of CCH and who had at least 1 valid S-GAIS evaluation after the injection of CCH. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 28, 56, 84, 112, 140, and 180 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body-Q Appraisal of Cellulite Total Score | The Body-Q Appraisal of Cellulite is a subset of 11 questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. Total score is the sum of all 11 question scores. The minimum possible total score is 11 and the maximum possible total score is 44. Higher scores indicate the individual is less bothered by their cellulite. | mITT Population: All enrolled participants who received at least 1 injection of CCH and who had an assessment as the specified timepoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 180 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite using a 4-point scale from a low of 0 to high of 3: 0 (absence of laxity, flaccidity, or sagging skin), 1 (slight draped appearance), 2 (moderate draped appearance), and 3 (severe draped appearance). The investigator or qualified designee used the Hexsel CSS Subsection D to assess the severity of dermal laxity in each buttock or each thigh independently. A decrease from baseline indicated a better outcome. | mITT Population: All enrolled participants who received at least 1 injection of CCH and who had an assessment as the specified timepoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Days 28, 56, 84, 112,140, and 180 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies | Blood samples were collected to assess anti-clostridial class I collagenase (AUX-I) and anti-Clostridial class II collagenase (AUX-II) antibody levels. The percentage of participants who were positive for anti-AUX-I and anti-AUX-II antibodies are presented. | mITT Population: All enrolled participants who received at least 1 injection of CCH and were assessed for anti-AUX-I and anti-AUX-II Antibodies at the specified timepoint. Immunogenicity analysis was conducted by overall participants and not treatment area/injection technique. | Posted | Number | percentage of participants | Day 180 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Positive for Neutralizing Antibodies to AUX-I and AUX-II | Blood samples were collected to assess neutralizing antibodies to AUX-I and AUX-II. The percentage of participants who were positive for neutralizing antibodies to AUX-I and AUX-II are presented. | mITT Population: All enrolled participants who received at least 1 injection of CCH and who had an assessment as the specified timepoint. Immunogenicity analysis was conducted by overall participants and not treatment area/injection technique. | Posted | Number | percentage of participants | Day 180 |
|
|
Day 1 (after dosing) through Day 180
Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
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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 | Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks or Thighs) | Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). | 0 | 16 | 0 | 16 | 16 | 16 |
| EG001 | Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks or Thighs) | Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). | 0 | 19 | 0 | 19 | 19 | 19 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | 23.1 | Systematic Assessment |
| |
| Implant site inflammation | General disorders | 23.1 | Systematic Assessment |
| |
| Implant site pain | General disorders | 23.1 | Systematic Assessment |
| |
| Injection site bruising | General disorders | 23.1 | Systematic Assessment |
| |
| Injection site discolouration | General disorders | 23.1 | Systematic Assessment |
| |
| Injection site mass | General disorders | 23.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | 23.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | 23.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | 23.1 | Systematic Assessment |
| |
| Injection site urticaria | General disorders | 23.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | 23.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Device breakage | Product Issues | 23.1 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Pityriasis rosea | Skin and subcutaneous tissue disorders | 23.1 | 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 | Jun 24, 2021 | Aug 28, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000071697 | Cellulite |
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
Not provided
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| 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
| 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 |
|
| OG002 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) |
Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). |
| OG003 | Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). |
|
|
| OG002 | Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). |
| OG003 | Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). |
|
|
| OG003 | Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). |
|
|
Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area).
| OG003 | Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). |
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