CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques

NCT04580303 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EN3835-224
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Edematous Fibrosclerotic Panniculopathy; Cellulite; Laxity; Skin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh

  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

  Days 28, 56, 84, 112, 140, and 180

• Change From Baseline in Body-Q Appraisal of Cellulite Total Score

  Baseline, Day 180

• Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score

  Baseline, Days 28, 56, 84, 112,140, and 180

• Percentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies

  Day 180

Study Arms (4)

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)

Drug: collagenase clostridium histolyticum

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)

Drug: collagenase clostridium histolyticum

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)

Drug: collagenase clostridium histolyticum

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)

Drug: collagenase clostridium histolyticum

Interventions

collagenase clostridium histolyticum DRUG

Delivered via uniform grid injection techniques.

Also known as: EN3835, CCH

Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thigh); Uniform 0.1-milliliters (mL) 1-Aliquot Grid Injection Technique (Buttock); Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttock); Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thigh)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have a body mass index of 18 to \<29.9 kilograms/square meters
• Have either both buttocks or both posterolateral thighs with:
• Score of 2 or 3 (mild or moderate cellulite) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS)
• Hexsel Cellulite Severity Scale (CSS) Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of 2 or 3 (moderate or severe) as determined by the investigator
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (3)

Endo Clinical Trial Site #3

Coral Gables, Florida, 33146, United States

Location

Endo Clinical Trial Site #2

Metairie, Louisiana, 70006, United States

Location

Endo Clinical Trial Site #1

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Cellulite; Cutis Laxa

Interventions

Microbial Collagenase

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Results Point of Contact

• Title: Clinical Operations
• Organization: Endo Pharmaceuticals

ClinicalTrials@Endo.com

1-800-462-3636

Study Officials

• David Hernandez

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 8, 2020
• Study Start: October 1, 2020
• Primary Completion: August 30, 2021
• Study Completion: September 24, 2021
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (3)