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

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

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

Study Overview

• Status: Completed
• Conditions: Cellulite; Edematous Fibrosclerotic Panniculopathy (EFP)
• Intervention / Treatment: Drug: CCH-aaes; Other: Compression; Other: Cold Packs; Drug: Arnica Gel; Drug: INhance®; Other: PDL

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Endo Clinical Trial Site #3
  • California
    • Sacramento, California, United States, 95816
      • Endo Clinical Trial Site #2
    • San Diego, California, United States, 92122
      • Endo Clinical Trial Site #7
  • Colorado
    • Fort Collins, Colorado, United States, 80525
      • Endo Clinical Trial Site #6
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Endo Clinical Trial Site #5
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Endo Clinical Trial Site #1
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Endo Clinical Trial Site #8
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Endo Clinical Trial Site #4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cohort 1: CCH-aaes; CCH-aaes was administered without mitigation treatment (control group).	Drug: CCH-aaes; Participants were administered CCH-aaes by subcutaneous injection to both buttocks.; Other Names: QWO™
Active Comparator: Cohort 2: CCH-aaes + Compression Garment; CCH-aaes was administered with compression garment.	Other: Compression; Participants used a compression garment on both buttocks following subcutaneous CCH-aaes injections.
Active Comparator: Cohort 3: CCH-aaes + Instant Cold Packs; CCH-aaes was administered with instant cold packs.	Other: Cold Packs; Participants used cold packs applied to the right buttock for 5-10 minutes immediately after subcutaneous CCH-aaes injections.
Active Comparator: Cohort 4: CCH-aaes + Arnica Gel Patches (OcuMend); CCH-aaes was administered with arnica gel patches (OcuMend).	Drug: Arnica Gel; Participants used Arnica Gel Patches (Arnica montana 50% and Ledum palustre) immediately after the CCH-aaes injection to the right buttock.
Active Comparator: Cohort 5:CCH-aaes + INhance Post-Injection Serum with TriHex Technology®; CCH-aaes was administered with INhance Post-Injection Serum with TriHex Technology®	Drug: INhance®; Participants used INhance Post-injection Serum topically immediately after the CCH-aaes injection to the right buttock.
Active Comparator: Cohort 6: CCH-aaes + Pulse Dye Laser Treatment (PDL); CCH-aaes was administered with PDL.	Other: PDL; Investigators applied one treatment with PDL to the right buttock between days 1-7 after injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4	Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-point photonumeric scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome.	Day 4 (3 days after CCH-aaes injection)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	The investigator assessed improvement of bruising using the I-BIS, a 3-point Likert scale that compares bruising on the mitigated side to the bruising on the non-mitigated side as either worse (1), the same (2), or improved (3). I-BIS Rating was directly obtained from the investigator's assessment rating comparing the bruising of the mitigation-treated buttock to the untreated (with mitigation treatment) buttock.	Days 4 and 7
Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS)	The investigator assessed improvement of bruising using the S-BIS, a 3-point Likert scale that compares bruising on the mitigated side to the bruising on the non-mitigated side as either worse (1), the same (2), or improved (3). S-BIS Rating was directly obtained from the participant's assessment rating comparing the bruising of the mitigation-treated buttock to the untreated (with mitigation treatment) buttock. The S-BIS assessment was not completed for participants that did not receive mitigation treatment (Cohort 1) or participants that received bilateral mitigation treatment (Cohort 2), as these participants did not have an untreated buttock as a comparator.	Days 4 and 7
Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4	The Patient Bother by Bruising Scale is a 4-point scale, with a score of 1 indicating not bothered at all, and a score of 4, indicating extremely bothered. A lower score indicates a better outcome.	Day 4
Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71	Improvement was defined as +1 or better score on the I-GAIS for either buttock on Day 71 compared to Baseline. The I-GAIS is a 7-level scale ranging from +3 (very much improved) to -3 (very much worse). A higher score indicated a better outcome.	Day 71
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7	Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome.	Day 7
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14	Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome.	Day 14
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22	Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome.	Day 22

Collaborators and Investigators

• 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.
• Investigators: Study Director: Medical Affairs, Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2020
• Primary Completion (Actual): June 26, 2021
• Study Completion (Actual): September 2, 2021

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Bruising mitigation; CCH-aaes
• Additional Relevant MeSH Terms: Wounds and Injuries; Skin Manifestations; Wounds, Nonpenetrating; Cellulite; Contusions
• Other Study ID Numbers: EN3835-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No