NCT04677712

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

MOBI: A Phase 4, Open-Label Study to Assess Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite in Adult Females

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

CCH-aaes is indicated for the treatment of moderate to severe cellulite in the buttocks of adult women. Since bruising may be bothersome, this study will investigate treatments that may mitigate bruising after treatment of cellulite in the buttocks.

Conditions

• Edematous Fibrosclerotic Panniculopathy (EFP)
• Cellulite

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-28
• Primary completion: 2021-06-26
• Completion: 2021-09-02
• First posted: 2020-12-21
• Last updated: 2023-08-21
• Results posted: 2023-08-21

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study