Real World CCH Study in Adult Females With Cellulite

• ClinicalTrials.gov Identifier: NCT04170296
• Recruitment Status: Completed
• First Posted: November 20, 2019
• Results First Posted: February 22, 2022
• Last Update Posted: February 22, 2022
• Sponsor: Endo Pharmaceuticals
• Information provided by (Responsible Party): Endo Pharmaceuticals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Edematous Fibrosclerotic Panniculopathy (EFP); Cellulite	Drug: EN3835	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 153 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Real World, Multicenter, Open-Label, Multiple Dose Study to Assess the Effectiveness of, and Satisfaction With, CCH Treatment of Buttocks or Thigh Cellulite in Adult Females
• Actual Study Start Date: November 1, 2019
• Actual Primary Completion Date: October 6, 2020
• Actual Study Completion Date: January 8, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort 1: Posterolateral Thigh; EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)	Drug: EN3835; Collagenase Clostridium Histolyticum (CCH)
Experimental: Cohort 2: Buttocks; EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)	Drug: EN3835; Collagenase Clostridium Histolyticum (CCH)

Outcome Measures

Primary Outcome Measures :

1. The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh [ Time Frame: 90 Days ]
   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".
2. The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock [ Time Frame: 90 Days ]
   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".

Secondary Outcome Measures :

1. Mean Change From Baseline in CR-PCSS for Each Buttock [ Time Frame: Day 22, 43, 90 and 180 ]
   Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (none) to "4" (severe) from a clinician's perspective.
2. Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score [ Time Frame: Day 90, Day 180 ]
   The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center
3. Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score [ Time Frame: Day 90, Day 180 ]
   The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center
4. The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh [ Time Frame: Day 22, 43, and 180 ]
   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".
5. The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock [ Time Frame: Day 22, 43, and 180 ]
   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".
6. Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh) [ Time Frame: Day 1, 90, and 180 ]
   Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
7. Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks) [ Time Frame: Day 1, 90 and 180 ]
   Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
8. Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) [ Time Frame: Day 1, 90 and 180 ]
   All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.
9. Presence of NAb Anti AUX-I and AUX-II (Buttocks) [ Time Frame: Day 1, 90 and 180 ]
   All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Have both buttocks or both posterolateral thighs with:

   1. A score of 2 or 3 (mild or moderate) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
   2. 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.
2. Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study.
3. Be judged to be in good health.
4. Have a negative pregnancy test.
5. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

1. 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).
2. Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.
3. Has systemic conditions (coagulation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation.
4. Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
5. Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin.
6. Has a Hexsel CSS Subsection D "Grade of laxity, flaccidity, or sagging skin" of 2 (moderate draped appearance) or 3 (severe draped appearance).
7. Requires anticoagulant or antiplatelet medication during the study.
8. Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
9. 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.
10. Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit.
11. 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.
12. Has any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.

Contacts and Locations

Locations

United States, California

Endo Clinical Trial Site #2

Encino, California, United States, 91436

Endo Clinical Trial Site #4

San Diego, California, United States, 92121

Endo Clinical Trial Site #5

Solana Beach, California, United States, 92075

United States, Connecticut

Endo Clinical Trial Site #9

Westport, Connecticut, United States, 00688

United States, Florida

Endo Clinical Trial Site #1

Coral Gables, Florida, United States, 33146

United States, Georgia

Endo Clinical Trial Site #10

Alpharetta, Georgia, United States, 30005

United States, Illinois

Endo Clinical Trial Site #3

Chicago, Illinois, United States, 60611

Endo Clinical Trial Site #11

Itasca, Illinois, United States, 60143

United States, Louisiana

Endo Clinical Trial Site #8

New Orleans, Louisiana, United States, 70130

United States, New York

Endo Clinical Trial Site #6

New York, New York, United States, 10021

United States, Tennessee

Endo Clinical Trial Site #12

Nashville, Tennessee, United States, 37215

Puerto Rico

Endo Clinical Trial Site #7

San Juan, Puerto Rico, 00917

Sponsors and Collaborators

Endo Pharmaceuticals

Investigators

• Study Director: David Hernandez; Endo Pharmaceuticals

  Study Documents (Full-Text)

Documents provided by Endo Pharmaceuticals:

Study Protocol  [PDF] June 1, 2020

Statistical Analysis Plan  [PDF] July 22, 2020

More Information

• Responsible Party: Endo Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04170296
• Other Study ID Numbers: EN3835-305
• First Posted: November 20, 2019
• Results First Posted: February 22, 2022
• Last Update Posted: February 22, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cellulite; Skin Manifestations