Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite

NCT04677712 | Completed Phase 4 Results FDA Drug

• 1 other identifier: EN3835-401
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 8

Brief Summary

This study will investigate treatments that may mitigate bruising after QWO™ (Collagenase clostridium histolyticum \[CCH\]-aaes) treatment of cellulite in the buttocks.

Conditions

Edematous Fibrosclerotic Panniculopathy (EFP); Cellulite

Keywords

Bruising mitigation; CCH-aaes

Outcome Measures

Primary Outcomes (1)

• Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4

  Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-point photonumeric scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome.

  Day 4 (3 days after CCH-aaes injection)

Secondary Outcomes (7)

• Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS)

  Days 4 and 7

• Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS)

  Days 4 and 7

• Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4

  Day 4

• Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71

  Day 71

• Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7

  Day 7

Study Arms (6)

Cohort 1: CCH-aaes

ACTIVE COMPARATOR

CCH-aaes was administered without mitigation treatment (control group).

Drug: CCH-aaes

Cohort 2: CCH-aaes + Compression Garment

ACTIVE COMPARATOR

CCH-aaes was administered with compression garment.

Other: Compression

Cohort 3: CCH-aaes + Instant Cold Packs

ACTIVE COMPARATOR

CCH-aaes was administered with instant cold packs.

Other: Cold Packs

Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)

ACTIVE COMPARATOR

CCH-aaes was administered with arnica gel patches (OcuMend).

Drug: Arnica Gel

Cohort 5:CCH-aaes + INhance Post-Injection Serum with TriHex Technology®

ACTIVE COMPARATOR

CCH-aaes was administered with INhance Post-Injection Serum with TriHex Technology®

Drug: INhance®

Cohort 6: CCH-aaes + Pulse Dye Laser Treatment (PDL)

ACTIVE COMPARATOR

CCH-aaes was administered with PDL.

Other: PDL

Interventions

CCH-aaes DRUG

Participants were administered CCH-aaes by subcutaneous injection to both buttocks.

Also known as: QWO™

Cohort 1: CCH-aaes

Compression OTHER

Participants used a compression garment on both buttocks following subcutaneous CCH-aaes injections.

Cohort 2: CCH-aaes + Compression Garment

Cold Packs OTHER

Participants used cold packs applied to the right buttock for 5-10 minutes immediately after subcutaneous CCH-aaes injections.

Cohort 3: CCH-aaes + Instant Cold Packs

Arnica Gel DRUG

Participants used Arnica Gel Patches (Arnica montana 50% and Ledum palustre) immediately after the CCH-aaes injection to the right buttock.

Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend)

INhance® DRUG

Participants used INhance Post-injection Serum topically immediately after the CCH-aaes injection to the right buttock.

Cohort 5:CCH-aaes + INhance Post-Injection Serum with TriHex Technology®

PDL OTHER

Investigators applied one treatment with PDL to the right buttock between days 1-7 after injection.

Cohort 6: CCH-aaes + Pulse Dye Laser Treatment (PDL)

Eligibility Criteria

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

You may qualify if:

• Have both buttocks with:
• Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) score of 3 (moderate) as reported by the Investigator, and
• 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).
• Have a body mass index between ≥18 and ≤30 kilograms (kg)/square meter (m\^2).
• Be willing to apply sunscreen before each exposure to the sun while participating in the study (that is, Baseline through end of study).
• Be judged to be in good health.
• Be willing and able to cooperate with the requirements of the study.

You may not qualify if:

• Has a coagulation disorder including but not limited to a Factor II, V, VII, or X deficiency.
• Has local conditions in the areas to be treated (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
• Has skin laxity or linear undulations on buttocks that can be effaced by lifting skin.
• Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before CCH-aaes treatment.
• Antiplatelet medication (clopidogrel \[Plavix®\] including aspirin at any dose within 14 days of treatment.
• Anticoagulants, such as warfarin (Coumadin®); heparin analogues within 14 days of treatment.
• Non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen (Motrin®, Advil®) and naproxen (Aleve®) 7 days before the study.
• Any medications or food that have or have been reported to have anticoagulant effects within 14 days of treatment.
• Antibiotics, such as penicillin and cephalosporin within 48 hours of treatment.
• Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
• Is pregnant and/or is presently nursing or providing breast milk or plans to become pregnant during the study.
• Intends to initiate an intensive sport or exercise program during the study.
• Tanning or use of tanning agents.
• Intends to engage in strenuous activity within 48 hours after the first injection of CCH-aaes.
• Has received an investigational drug or treatment within 30 days prior to injection of CCH-aaes.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead
• DeNova Research: collaborator
• University of California, San Diego: collaborator
• The Wall Center for Plastic Surgery: collaborator
• Mathew Avram, MD: collaborator
• Laser & Skin Surgery Medical Group, Inc.: collaborator
• Investigate MD, LLC: collaborator
• Biesman, Brian, M.D.: collaborator
• Plastic Surgical Associates of Fort Collins, P.C.: collaborator

Study Sites (8)

Endo Clinical Trial Site #3

Scottsdale, Arizona, 85255, United States

Location

Endo Clinical Trial Site #2

Sacramento, California, 95816, United States

Location

Endo Clinical Trial Site #7

San Diego, California, 92122, United States

Location

Endo Clinical Trial Site #6

Fort Collins, Colorado, 80525, United States

Location

Endo Clinical Trial Site #5

Chicago, Illinois, 60611, United States

Location

Endo Clinical Trial Site #1

Shreveport, Louisiana, 71105, United States

Location

Endo Clinical Trial Site #8

Boston, Massachusetts, 02114, United States

Location

Endo Clinical Trial Site #4

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Cellulite

Interventions

Vascularin-Gel

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Operations
• Organization: Endo Pharmaceuticals

ClinicalTrials@Endo.com

1-800-462-3636

Study Officials

• Medical Affairs

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 21, 2020
• Study Start: December 28, 2020
• Primary Completion: June 26, 2021
• Study Completion: September 2, 2021
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2023-08

Data Sharing

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

Locations

US (8)