Real World CCH Study in Adult Females With Cellulite

NCT04170296 | Completed Phase 3 Results FDA Drug

• 1 other identifier: EN3835-305
• Study Type: interventional
• Target: 153
• Locations: 2 countries
• Sites: 12

Brief Summary

This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP). Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or moderate EFP in the buttocks.

Conditions

Edematous Fibrosclerotic Panniculopathy (EFP); Cellulite

Outcome Measures

Primary Outcomes (2)

• The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh

  Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".

  90 Days

• The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock

  Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".

  90 Days

Secondary Outcomes (9)

• Mean Change From Baseline in CR-PCSS for Each Buttock

  Day 22, 43, 90 and 180

• Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score

  Day 90, Day 180

• Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score

  Day 90, Day 180

• The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh

  Day 22, 43, and 180

• The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock

  Day 22, 43, and 180

Study Arms (2)

Cohort 1: Posterolateral Thigh

EXPERIMENTAL

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

Drug: EN3835

Cohort 2: Buttocks

EXPERIMENTAL

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

Drug: EN3835

Interventions

EN3835 DRUG

Collagenase Clostridium Histolyticum (CCH)

Cohort 1: Posterolateral Thigh; Cohort 2: Buttocks

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have both buttocks or both posterolateral thighs with:
• A score of 2 or 3 (mild or moderate) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
• A Hexsel Cellulite Severity Scale (CSS) Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of 0 (absence of laxity, flaccidity, or sagging skin), or 1 (slightly draped appearance) at the Screening Visit only.
• Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study.
• Be judged to be in good health.
• Have a negative pregnancy test.
• Be willing and able to cooperate with the requirements of the study.

You may not qualify if:

• Is from a vulnerable population, as defined by the United States (US) Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, 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).
• Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.
• Has systemic conditions (coagulation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation.
• Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
• Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin.
• Has a Hexsel CSS Subsection D "Grade of laxity, flaccidity, or sagging skin" of 2 (moderate draped appearance) or 3 (severe draped appearance).
• Requires anticoagulant or antiplatelet medication during the study.
• Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
• Has received any collagenase treatments at any time prior to treatment in this study and/or has received previous treatment with EN3835 or CCH for cellulite.
• Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit.
• Is pregnant and/or is providing breast milk in any manner, or plans to become pregnant and/or to provide breast milk during the course of the study.
• Has any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (12)

Endo Clinical Trial Site #2

Encino, California, 91436, United States

Location

Endo Clinical Trial Site #4

San Diego, California, 92121, United States

Location

Endo Clinical Trial Site #5

Solana Beach, California, 92075, United States

Location

Endo Clinical Trial Site #9

Westport, Connecticut, 00688, United States

Location

Endo Clinical Trial Site #1

Coral Gables, Florida, 33146, United States

Location

Endo Clinical Trial Site #10

Alpharetta, Georgia, 30005, United States

Location

Endo Clinical Trial Site #3

Chicago, Illinois, 60611, United States

Location

Endo Clinical Trial Site #11

Itasca, Illinois, 60143, United States

Location

Endo Clinical Trial Site #8

New Orleans, Louisiana, 70130, United States

Location

Endo Clinical Trial Site #6

New York, New York, 10021, United States

Location

Endo Clinical Trial Site #12

Nashville, Tennessee, 37215, United States

Location

Endo Clinical Trial Site #7

San Juan, 00917, Puerto Rico

Location

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: David Hernandez, MD
• Organization: Endo Pharmaceuticals

clinicaltrials@endo.com

800-462-3636

Study Officials

• David Hernandez

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: November 1, 2019
• Primary Completion: October 6, 2020
• Study Completion: January 8, 2021
• Last Updated: February 22, 2022
• Results First Posted: February 22, 2022

Record last verified: 2022-01

Data Sharing

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

Locations

PR (1); US (11)