Real World CCH Study in Adult Females With Cellulite (NCT04170296) | Clinical Trial Compass
CompletedPhase 3
Real World CCH Study in Adult Females With Cellulite
United States153 participantsStarted 2019-11-01
Plain-language summary
This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP).
Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or moderate EFP in the buttocks.
Who can participate
Age range18 Years – 60 Years
SexFEMALE
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Inclusion criteria
✓. Have both buttocks or both posterolateral thighs with:
✓. A score of 2 or 3 (mild or moderate) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
✓. A 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) at the Screening Visit only.
✓. Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study.
✓. Be judged to be in good health.
✓. Have a negative pregnancy test.
✓. Be willing and able to cooperate with the requirements of the study.
Exclusion criteria
✕. Is from a vulnerable population, as defined by the United States (US) Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
✕. Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.
✕. Has systemic conditions (coagulation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation.
What they're measuring
1
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh
Timeframe: 90 Days
2
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
✕. Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
✕. Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin.
✕. Has a Hexsel CSS Subsection D "Grade of laxity, flaccidity, or sagging skin" of 2 (moderate draped appearance) or 3 (severe draped appearance).
✕. Requires anticoagulant or antiplatelet medication during the study.
✕. Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.