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

Endo Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Cellulite; Edematous Fibrosclerotic Panniculopathy (EFP)

Treatments: Drug: CCH-aaes; Other: PDL; Other: Compression; Drug: Arnica Gel; Other: Cold Packs; Drug: INhance®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04677712

EN3835-401

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Have both buttocks with:

   1. Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) score of 3 (moderate) as reported by the Investigator, and
   2. 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).

2. Have a body mass index between ≥18 and ≤30 kilograms (kg)/square meter (m^2).

3. Be willing to apply sunscreen before each exposure to the sun while participating in the study (that is, Baseline through end of study).

4. Be judged to be in good health.

5. Be willing and able to cooperate with the requirements of the study.

Key Exclusion Criteria:

1. Has a coagulation disorder including but not limited to a Factor II, V, VII, or X deficiency.

2. Has local conditions in the areas to be treated (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.

3. Has skin laxity or linear undulations on buttocks that can be effaced by lifting skin.

4. Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before CCH-aaes treatment.

   1. Antiplatelet medication (clopidogrel [Plavix®] including aspirin at any dose within 14 days of treatment.
   2. Anticoagulants, such as warfarin (Coumadin®); heparin analogues within 14 days of treatment.
   3. Non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen (Motrin®, Advil®) and naproxen (Aleve®) 7 days before the study.
   4. Any medications or food that have or have been reported to have anticoagulant effects within 14 days of treatment.
   5. Antibiotics, such as penicillin and cephalosporin within 48 hours of treatment.

5. Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.

6. Is pregnant and/or is presently nursing or providing breast milk or plans to become pregnant during the study.

7. Intends to initiate an intensive sport or exercise program during the study.

8. Tanning or use of tanning agents.

9. Intends to engage in strenuous activity within 48 hours after the first injection of CCH-aaes.

10. Has received an investigational drug or treatment within 30 days prior to injection of CCH-aaes.

11. Has a history of hypersensitivity or allergy to collagenase or any other excipient of CCH-aaes.

12. Has a known systemic allergy or local sensitivity to any of the mitigation treatments or including excipients (that is, arnica patches, INhance Post-injection Serum).

13. Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH-aaes in a previous investigational study for cellulite.

14. For participants allocated to PDL treatment Participants will be excluded from PDL treatment if they have any contraindications to PDL a. exposure to Accutane® (isotretinoin) within 6 months of CCH-aaes treatment.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 6 patient groups

Cohort 1: CCH-aaes

Active Comparator group

Description:

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

Treatment:

Drug: CCH-aaes

Cohort 2: CCH-aaes + Compression Garment

Active Comparator group

Description:

CCH-aaes was administered with compression garment.

Treatment:

Other: Compression

Cohort 3: CCH-aaes + Instant Cold Packs

Active Comparator group

Description:

CCH-aaes was administered with instant cold packs.

Treatment:

Other: Cold Packs

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

Active Comparator group

Description:

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

Treatment:

Drug: Arnica Gel

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

Active Comparator group

Description:

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

Treatment:

Drug: INhance®

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

Active Comparator group

Description:

CCH-aaes was administered with PDL.

Treatment:

Other: PDL