Clinical trial NCT04170296: Real World CCH Study in Adult Females With Cellulite
Official title: A Real World, Multicenter, Open-Label, Multiple Dose Study to Assess the Effectiveness of, and Satisfaction With, CCH Treatment of Buttocks or Thigh Cellulite in Adult Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Edematous Fibrosclerotic Panniculopathy (EFP)
Cellulite
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-11-20
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Have both buttocks or both posterolateral thighs with:

   1. A score of 2 or 3 (mild or moderate) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
   2. 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.
2. Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study.
3. Be judged to be in good health.
4. Have a negative pregnancy test.
5. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

1. 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).
2. Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.
3. Has systemic conditions (coagulation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation.
4. Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
5. Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin.
6. Has a Hexsel CSS Subsection D "Grade of laxity, flaccidity, or sagging skin" of 2 (moderate draped appearance) or 3 (severe draped appearance).
7. Requires anticoagulant or antiplatelet medication during the study.
8. Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
9. Has received any collagenase treatments at any time prior to treatment in this study and/or has received previous treatment with EN3835 or CCH for cellulite.
10. Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit.
11. Is pregnant and/or is providing breast milk in any manner, or plans to become pregnant and/or to provide breast milk during the course of the study.
12. Has any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.

Primary outcomes:
measure: The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh
timeFrame: 90 Days
measure: The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
timeFrame: 90 Days
Secondary outcomes:
measure: Mean Change From Baseline in CR-PCSS for Each Buttock
timeFrame: Day 22, 43, 90 and 180
measure: Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score
timeFrame: Day 90, Day 180
measure: Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score
timeFrame: Day 90, Day 180
measure: The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh
timeFrame: Day 22, 43, and 180
measure: The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
timeFrame: Day 22, 43, and 180
measure: Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh)
timeFrame: Day 1, 90, and 180
measure: Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks)
timeFrame: Day 1, 90 and 180
measure: Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
timeFrame: Day 1, 90 and 180
measure: Presence of NAb Anti AUX-I and AUX-II (Buttocks)
timeFrame: Day 1, 90 and 180
Other outcomes:
Locations:
city: Encino
country: United States
facility: Endo Clinical Trial Site #2
state: California
city: San Diego
country: United States
facility: Endo Clinical Trial Site #4
state: California
city: Solana Beach
country: United States
facility: Endo Clinical Trial Site #5
state: California
city: Westport
country: United States
facility: Endo Clinical Trial Site #9
state: Connecticut
city: Coral Gables
country: United States
facility: Endo Clinical Trial Site #1
state: Florida
city: Alpharetta
country: United States
facility: Endo Clinical Trial Site #10
state: Georgia
city: Chicago
country: United States
facility: Endo Clinical Trial Site #3
state: Illinois
city: Itasca
country: United States
facility: Endo Clinical Trial Site #11
state: Illinois
city: New Orleans
country: United States
facility: Endo Clinical Trial Site #8
state: Louisiana
city: New York
country: United States
facility: Endo Clinical Trial Site #6
state: New York
city: Nashville
country: United States
facility: Endo Clinical Trial Site #12
state: Tennessee
city: San Juan
country: Puerto Rico
facility: Endo Clinical Trial Site #7
Study officials:
affiliation: Endo Pharmaceuticals
name: David Hernandez
role: STUDY_DIRECTOR
References: