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

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ClinicalTrials.gov Identifier: NCT04677712
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 4, 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
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bruises

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




Primary Outcome Measures :
  1. Investigator Assessment of Bruising Severity Scale [ Time Frame: Day 1 - Day 71 ]
    The proportion of subjects 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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04677712


Contacts
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Contact: Robert Yon 800-462-3636 ClinicalTrials@Endo.com
Contact: Michael McLane 800-462-3636 ClinicalTrials@Endo.com

Locations
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United States, Arizona
Endo Clinical Trial Site #3 Recruiting
Scottsdale, Arizona, United States, 85255
United States, California
Endo Clinical Trial Site #2 Recruiting
Sacramento, California, United States, 95816
United States, Colorado
Endo Clinical Trial Site #6 Recruiting
Fort Collins, Colorado, United States, 80525
United States, Illinois
Endo Clinical Trial Site #5 Recruiting
Chicago, Illinois, United States, 60611
United States, Louisiana
Endo Clinical Trial Site #1 Recruiting
Shreveport, Louisiana, United States, 71105
United States, Tennessee
Endo Clinical Trial Site #4 Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Kadriye Ciftci Endo Pharmaceutical
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04677712    
Other Study ID Numbers: EN3835-401
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cellulite
Skin Manifestations