Clinical trial NCT04677712: Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite
Official title: MOBI: A Phase 4, Open-Label Study to Assess Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite in Adult Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Edematous Fibrosclerotic Panniculopathy (EFP)
Cellulite
Keywords: Bruising mitigation
CCH-aaes
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: DeNova Research
name: University of California, San Diego
name: The Wall Center for Plastic Surgery
name: Mathew Avram, MD
name: Laser & Skin Surgery Medical Group, Inc.
name: Investigate MD, LLC
name: Biesman, Brian, M.D.
name: Plastic Surgical Associates of Fort Collins, P.C.
First posted: 2020-12-21
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
timeFrame: Day 4 (3 days after CCH-aaes injection)
Secondary outcomes:
measure: 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)
timeFrame: Days 4 and 7
measure: Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS)
timeFrame: Days 4 and 7
measure: Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4
timeFrame: Day 4
measure: Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71
timeFrame: Day 71
measure: Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7
timeFrame: Day 7
measure: The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14
timeFrame: Day 14
measure: The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22
timeFrame: Day 22
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Endo Clinical Trial Site #3
state: Arizona
city: Sacramento
country: United States
facility: Endo Clinical Trial Site #2
state: California
city: San Diego
country: United States
facility: Endo Clinical Trial Site #7
state: California
city: Fort Collins
country: United States
facility: Endo Clinical Trial Site #6
state: Colorado
city: Chicago
country: United States
facility: Endo Clinical Trial Site #5
state: Illinois
city: Shreveport
country: United States
facility: Endo Clinical Trial Site #1
state: Louisiana
city: Boston
country: United States
facility: Endo Clinical Trial Site #8
state: Massachusetts
city: Nashville
country: United States
facility: Endo Clinical Trial Site #4
state: Tennessee
Study officials:
affiliation: Endo Pharmaceuticals
name: Medical Affairs
role: STUDY_DIRECTOR
References: