Phase 4
N=48
Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite
Edematous Fibrosclerotic Panniculopathy (EFP) · Cellulite
Bottom Line
View on ClinicalTrials.gov: NCT04677712 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- CCH-aaes (Drug); Compression (Other); Cold Packs (Other); Arnica Gel (Drug); INhance® (Drug); PDL (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Endo Pharmaceuticals
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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) |
2; 4; 2; 4; 4; 5 | — |
| SECONDARY Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS) |
0; 3; 1; 3; 4; 4 | — |
| SECONDARY Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4 |
3; 5; 9; 5; 4; 1 | — |
| SECONDARY Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71 |
6; 6; 9; 9; 7; 5 | — |
| SECONDARY Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7 |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14 |
3; 5; 8; 7; 4; 3 | — |
| SECONDARY The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22 |
6; 7; 9; 9; 6; 7 | — |
Summary
This study will investigate treatments that may mitigate bruising after QWO™ (Collagenase clostridium histolyticum [CCH]-aaes) treatment of cellulite in the buttocks.
Eligibility Criteria
Key Inclusion Criteria
- 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.
Key Exclusion Criteria
- 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.
- Has a history of hypersensitivity or allergy to collagenase or any other excipient of CCH-aaes.
- 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).
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT04677712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.