Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Women

NCT04209530 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: EN3835-212
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, open-label, Phase 2a study to assess the photonumeric scale, morphological, and histopathological changes associated with Collagenase Clostridium Histolyticum (CCH) in adult women with moderate or severe Edematous Fibrosclerotic Panniculopathy (EFP).

Conditions

Cellulite; Edematous Fibrosclerotic Panniculopathy (EFP)

Outcome Measures

Primary Outcomes (1)

• The Change From Baseline (Screening) in PR-PCSS

  Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (None) to "4" (Severe) from a patient's perspective

  Day 71

Secondary Outcomes (4)

• The Change From Baseline (Screening) in CR-PCSS

  Day 22, Day 43 and Day 71

• The Change From Baseline (Screening) in Hexsel Cellulite Severity Scale (CSS)

  Day 22, Day 43 and Day 71

• MRI Before and After CCH Treatment

  Day 71

• Histopathology Before and After CCH Treatment

  Day 71

Study Arms (1)

Buttock & Posterolateral Thigh

EXPERIMENTAL

EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)

Drug: EN3835

Interventions

EN3835 DRUG

Collagenase Clostridium Histolyticum (CCH)

Buttock & Posterolateral Thigh

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have both buttocks or both posterolateral thighs with:
• A score of 3 or 4 (moderate or severe) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
• A Hexsel Cellulite Severity Scale (CSS) Subsection A "Number of Evident Depressions" score of \>0, and Subsection B "Depth of Depressions" score of 2 )medium depth depression) or 3 (deep depressions)..
• Have a minimum of 2 well defined and isolated cellulite dimples.
• Be willing to apply sunscreen to the treatment area before each exposure to the sun for the duration of the study (from the Screening Visit through the Day 251/Early Termination Visit).
• 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 scar, 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.
• 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 used any form of artificial tanning (sprays, lotions, tanning booth, etc) within the 30 days prior to the first dose of study treatment or plans to use any form of artificial tanning during the study (through the Day 251/Early Termination Visit).
• Has a positive HIV test and/or a positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) test at screening.
• Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment.
• Has a history of keloids, hypertrophied scars, and/or other complications following biopsy.
• Has any contraindications for MRI(implant containing metal, internal metallic object, permanent cosmetics/make-up, claustrophobia, syncope, low blood pressure, epilepsy, asthma, sickle cell disease) that restricts study participation.
• 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.
• Has previously received treatment with CCH in this clinical study.
• Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (1)

Endo Clinical Trial Site #1

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Saji Vijayan, MBBS
• Organization: Endo Pharmaceuticals

clinicaltrials@endo.com

800-462-3636

Study Officials

• Ashley Dayoub

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 24, 2019
• Study Start: November 20, 2019
• Primary Completion: July 23, 2020
• Study Completion: October 5, 2020
• Last Updated: October 7, 2021
• Results First Posted: October 7, 2021

Record last verified: 2020-11

Data Sharing

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

Locations

US (1)