Edematous Fibrosclerotic Panniculopathy
Conditions
Keywords
EFP, Cellulite
Brief summary
This study will evaluate the long-term safety and duration of efficacy of CCH in the treatment of women with cellulite. This study will be a single day evaluation, approximately 48 months after the first dose of study drug was received in the EN3835-201.
Interventions
No treatment to be administered - Observational only
Sponsors
Endo Pharmaceuticals
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have participated in and completed studies EN3835-201, EN3835-202 and EN3835-219 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201. 2. Be willing and able to cooperate with the requirements of the study.
Exclusion criteria
1. Has had retreatment with CCH in the area initially treated during the EN3835-201 study since the completion of study EN3835-219. 2. Has received collagenase treatments (eg, Santyl® Ointment and/or Xiaflex®/Xiapex®) since the completion of study EN3835-219. 3. Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study. 4. Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-201 study since the completion of that study. 5. Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study | Approximately 4 weeks | Clinician Reported-Photonumeric Cellulite Severity Scale is a 5-level photonumeric scale with ratings ranging from 0 (None) to 4 (Severe) |
| PR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study | Approximately 4 weeks | Patient Reported-Photonumeric Cellulite Severity Scale is a 5-level photonumeric scale with ratings ranging from 0 (None) to 4 (Severe) |
Countries
United States
Outcome results
None listed