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

• ClinicalTrials.gov Identifier: NCT04677712
• Recruitment Status: Completed
• First Posted: December 21, 2020
• Last Update Posted: November 10, 2021
• Sponsor: Endo Pharmaceuticals
• Collaborators: 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.
• Information provided by (Responsible Party): Endo Pharmaceuticals

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
Edematous Fibrosclerotic Panniculopathy (EFP); Cellulite	Drug: QWO™(CCH-aaes) + No Mitigation Treatment; Drug: QWO™(CCH-aaes) + Compression; Drug: QWO™(CCH-aaes) + Cold Packs; Drug: QWO™(CCH-aaes) + Arnica gel; Drug: QWO™(CCH-aaes) + INhance®; Drug: QWO™(CCH-aaes) + PDL	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Collaborative Research, Open-Label Study to Assess Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite in Adult Females
• Actual Study Start Date: December 16, 2020
• Actual Primary Completion Date: June 26, 2021
• Actual Study Completion Date: September 2, 2021

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 :

1. Investigator Assessment of Bruising Severity Scale [ Time Frame: 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 :

1. Investigator-Bruising Improvement Scale [ Time Frame: 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
2. Investigator Assessment of Bruising Severity Scale [ Time Frame: 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.
3. Subject-Bruising Improvement Scale (S-BIS) [ Time Frame: 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
4. Patient Bother by Bruising Scale [ Time Frame: 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
5. Investigator-Global Aesthetic Improvement Scale (I-GAIS) [ Time Frame: 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

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Have both buttocks with:

   1. a CR-PCSS score of 3 (moderate) as reported by the Investigator, and
   2. 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).
2. Have a body mass index between ≥18 and ≤30 kg/m^2.
3. 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).
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 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).
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 QWO (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 QWO (CCH-aaes).
10. Has received an investigational drug or treatment within 30 days prior to injection of QWO (CCH-aaes).
11. Has a history of hypersensitivity or allergy to collagenase or any other excipient of QWO (CCH-aaes).
12. Has a known systemic allergy or local sensitivity to any of the mitigation treatments or including excipients (ie, 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 QWO (CCH-aaes) in a previous investigational study for cellulite.
14. 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

United States, Arizona

Endo Clinical Trial Site #3

Scottsdale, Arizona, United States, 85255

United States, California

Endo Clinical Trial Site #2

Sacramento, California, United States, 95816

Endo Clinical Trial Site #7

San Diego, California, United States, 92122

United States, Colorado

Endo Clinical Trial Site #6

Fort Collins, Colorado, United States, 80525

United States, Illinois

Endo Clinical Trial Site #5

Chicago, Illinois, United States, 60611

United States, Louisiana

Endo Clinical Trial Site #1

Shreveport, Louisiana, United States, 71105

United States, Massachusetts

Endo Clinical Trial Site #8

Boston, Massachusetts, United States, 02114

United States, Tennessee

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

More Information

• Responsible Party: Endo Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04677712
• Other Study ID Numbers: EN3835-401
• First Posted: December 21, 2020
• Last Update Posted: November 10, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cellulite; Skin Manifestations