MOBI: Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite
Study Details
Study Description
Brief Summary
QWO™ (CCH-aaes) is indicated for the treatment of moderate to severe cellulite in the buttocks of adult women. QWO™ (CCH-aaes)-related post-injection bruising was the most common adverse reaction; generally, resolving within 21 days. Since bruising may be bothersome to patients, this study will investigate treatments that may mitigate bruising after QWO™ (CCH-aaes) treatment of cellulite in the buttocks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Cohort 1
|
Drug: QWO™(CCH-aaes) + No Mitigation Treatment
Cohort 1 will serve as a control and no mitigation treatment will be administered
|
| Active Comparator: Cohort 2: Compression Garments
|
Drug: QWO™(CCH-aaes) + Compression
Participants will use compression garments
|
| Active Comparator: Cohort 3: Instant Cold Packs
|
Drug: QWO™(CCH-aaes) + Cold Packs
Participants will use cold packs
|
| Active Comparator: Cohort 4: Arnica Gel Patches (OcuMend)
|
Drug: QWO™(CCH-aaes) + Arnica gel
Participants will use Arnica Gel Patches
|
| Active Comparator: Cohort 5: INhance Post-Injection Serum with TriHex Technology®
|
Drug: QWO™(CCH-aaes) + INhance®
Participants will use INhance®
|
| Active Comparator: Cohort 6: Pulse Dye Laser Treatment (PDL)
|
Drug: QWO™(CCH-aaes) + PDL
Participants will be treated with PDL
|
Outcome Measures
Primary Outcome Measures
- Investigator Assessment of Bruising Severity Scale [Day 4]
The proportion of participants by buttock at each level of bruising on the Investigator Assessment of Bruising Severity Scale, after QWO™ (CCH-aaes) injection. This 5-level scale ranges from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising.
Secondary Outcome Measures
- Investigator-Bruising Improvement Scale [Day 2, 4, 7, 14, and 22]
The proportion of participants with an improvement of bruising on the mitigation treated buttock on the Investigator-Bruising Improvement Scale (I-BIS), a 3-point Likert scale, with a score on the higher end of the range indicating improvement with treatment
- Investigator Assessment of Bruising Severity Scale [Day 1, 2, 4, 7, 14, and 22]
The proportion of participants by buttock at each level of bruising on the Investigator Assessment of Bruising Severity Scale, by visit. This 5-level scale ranges from 0 to 4, with 0 indicating no bruising or almost none, and 4 indicating severe bruising.
- Subject-Bruising Improvement Scale (S-BIS) [Day 2, 4, 7, 14, and 22]
The proportion of participants treated with QWO™ (CCH-aaes) with an improvement of bruising on the mitigation treated buttock on the Subject-Bruising Improvement Scale (S-BIS), a 3-point Likert scale, with a score on the higher end of the range indicating improvement of bruising with treatment
- Patient Bother by Bruising Scale [Day 4, 7, and 22]
The proportion of participants by buttock on the Patient Bother by Bruising Scale, a 4-point scale, with a score of 1 indicating not bothered at all, and a score of 4, indicating extremely bothered
- Investigator-Global Aesthetic Improvement Scale (I-GAIS) [Day 22, 43, and 71]
The proportion of participants with an improved (+1 or better) score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for either buttock. The I-GAIS is a 7-level scale ranging from +3 (very much improved) to -3 (very much worse)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have both buttocks with:
-
a CR-PCSS score of 3 (moderate) as reported by the Investigator, and
-
a Hexsel 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 kg/m^2.
-
Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study (from Screening Visit through the Day 71/Early Termination Visit).
-
Be judged to be in good health.
-
Be willing and able to cooperate with the requirements of the study.
Exclusion Criteria:
-
Has Coagulation disorder, which requires anticoagulant or antiplatelet medication during the study (except for < 150 mg aspirin daily), or has taken anticoagulant or antiplatelet medication(s) within 14 days before injection of study treatment (except for < 150 mg aspirin daily).
-
Has local conditions in the areas to be treated (Thrombosis, Vascular disorder, Active infection/inflammation, Active cutaneous alteration, Tattoo/mole) that restricts study participation.
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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 QWO (CCH-aaes) treatment.
-
Antiplatelet medication (clopidogrel [Plavix®] including aspirin at any dose within 14 days of treatment.
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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.
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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.
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Is pregnant and/or is presently nursing or providing breast milk or plans to become pregnant during the study.
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Intends to initiate an intensive sport or exercise program during the study.
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Tanning or use of tanning agents.
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Intends to engage in strenuous activity within 48 hours after the first injection of QWO (CCH-aaes).
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Has received an investigational drug or treatment within 30 days prior to injection of QWO (CCH-aaes).
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Has a history of hypersensitivity or allergy to collagenase or any other excipient of QWO (CCH-aaes).
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Has a known systemic allergy or local sensitivity to any of the mitigation treatments or including excipients (ie, 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 QWO (CCH-aaes) in a previous investigational study for cellulite.
-
For subjects allocated to PDL treatment Subjects will be excluded from PDL treatment if they have any contraindications to PDL a. exposure to Accutane® (isotretinoin) within 6 months of QWO (CCH-aaes) treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Endo Clinical Trial Site #3 | Scottsdale | Arizona | United States | 85255 |
| 2 | Endo Clinical Trial Site #2 | Sacramento | California | United States | 95816 |
| 3 | Endo Clinical Trial Site #7 | San Diego | California | United States | 92122 |
| 4 | Endo Clinical Trial Site #6 | Fort Collins | Colorado | United States | 80525 |
| 5 | Endo Clinical Trial Site #5 | Chicago | Illinois | United States | 60611 |
| 6 | Endo Clinical Trial Site #1 | Shreveport | Louisiana | United States | 71105 |
| 7 | Endo Clinical Trial Site #8 | Boston | Massachusetts | United States | 02114 |
| 8 | Endo Clinical Trial Site #4 | Nashville | Tennessee | United States | 37203 |
Sponsors and Collaborators
- Endo Pharmaceuticals
- DeNova Research
- UCSD Dermatology
- The Wall Center for Plastic Surgery
- Mathew Avram, MD
- Laser & Skin Surgery Medical Group, Inc.
- Investigate MD, LLC
- Brian Biesman, MD, PLLC
- Plastic Surgical Associates of Fort Collins, P.C.
Investigators
- Study Director: Ravi Tayi, Endo Pharmaceutical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EN3835-401