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

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

Interventions

DRUG

CCH-aaes

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

OTHER

Compression

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

OTHER

Cold Packs

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

DRUG

Arnica Gel

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

DRUG

INhance®

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

OTHER

PDL

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

Sponsors & Collaborators

• DeNova Research

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• The Wall Center for Plastic Surgery

  collaborator OTHER

• Mathew Avram, MD

  collaborator UNKNOWN

• Laser & Skin Surgery Medical Group, Inc.

  collaborator OTHER

• Investigate MD, LLC

  collaborator OTHER

• Biesman, Brian, M.D.

  collaborator INDIV

• Plastic Surgical Associates of Fort Collins, P.C.

  collaborator OTHER

• Endo Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Medical Affairs · Endo Pharmaceuticals

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-12-28

Primary Completion

2021-06-26

Completion

2021-09-02

FDA Drug

Yes

Countries

• United States

Study Locations