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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-28

Study Completion Date

2021-09-02

Brief Summary

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

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Detailed Description

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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

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Edematous Fibrosclerotic Panniculopathy (EFP) Cellulite

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cohort 1: CCH-aaes

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

Group Type ACTIVE_COMPARATOR

CCH-aaes

Intervention Type DRUG

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

Cohort 2: CCH-aaes + Compression Garment

CCH-aaes was administered with compression garment.

Group Type ACTIVE_COMPARATOR

Compression

Intervention Type OTHER

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

Cohort 3: CCH-aaes + Instant Cold Packs

CCH-aaes was administered with instant cold packs.

Group Type ACTIVE_COMPARATOR

Cold Packs

Intervention Type OTHER

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

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

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

Group Type ACTIVE_COMPARATOR

Arnica Gel

Intervention Type DRUG

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

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

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

Group Type ACTIVE_COMPARATOR

INhance®

Intervention Type DRUG

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

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

CCH-aaes was administered with PDL.

Group Type ACTIVE_COMPARATOR

PDL

Intervention Type OTHER

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

Interventions

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CCH-aaes

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

Intervention Type DRUG

Compression

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

Intervention Type OTHER

Cold Packs

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

Intervention Type OTHER

Arnica Gel

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

Intervention Type DRUG

INhance®

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

Intervention Type DRUG

PDL

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

Intervention Type OTHER

Other Intervention Names

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QWO™

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes