Edematous Fibrosclerotic Panniculopathy
Conditions
Keywords
Edematous Fibrosclerotic Panniculopathy, EFP, Cellulite
Brief summary
This is a Phase 2b, rollover, long-term study to evaluate the safety and duration of efficacy of EN3835 in the treatment of women with EFP. Subjects who participated in and completed studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201 will be eligible for this study.
Interventions
BIOLOGICALPreviously Treated with EN3835
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
* To qualify for the study a subject must: 1. Be able to provide voluntary written informed consent prior to the initiation of any study-specific procedures per the policy of the governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC). 2. Have participated in and completed both studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201. 3. Be willing and able to comply with all protocol required visits and assessments.
Exclusion criteria
* Subjects will be ineligible for participation in this study if the subject: 1. Has had retreatment with EN3835 in the area initially treated during the EN3835-201 study since the completion of study EN3835-202. 2. Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study. 3. Has had any of the following in the area initially treated during the EN3835-201 study since the completion of that study. 1. Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision and/or powered subcision). 2. Any investigational treatment for EFP/cellulite. 3. Endermologie® or similar treatments. 4. Massage therapy. 5. Creams (eg, Celluvera™, TriLastin®). 4. Any other condition(s) that, in the Investigator's opinion, might indicate the subject is unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of response to treatment with EN3835 in subjects with EFP as assessed using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) | Change from baseline (pre-dose, Day 1) of response to treatment, approximately 3 years post treatment in EN3835-201 Study | Change from baseline (pre-dose, Day 1) of EN3835-201 study in CR-PCSS Scale is 5-levels, 0=None to 4=Severe |
| Change from baseline of response to treatment with EN3835 in subjects with EFP as assessed using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) | Change from baseline (pre-dose, Day 1) of response to treatment, approximately 3 years post treatment in EN3835-201 Study | Change from baseline (pre-dose, Day 1) of EN3835-201 study in PR-PCSS Scale is 5-levels, 0=None to 4=Severe |
| Change from reference time point of response to treatment with EN3835 in subjects with EFP as assessed using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) | Change from reference time point (Day 71), approximately 3 years post treatment in EN3835-201 Study | Change from reference time point (Day 71) of EN3835-201 study in CR-PCSS Scale is 5-levels, 0=None to 4=Severe |
| Change from reference time point of response to treatment with EN3835 in subjects with EFP as assessed using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) | Change from reference time point (Day 71), approximately 3 years post treatment in EN3835-201 Study | Change from reference time point (Day 71) of EN3835-201 study in PR-PCSS Scale is 5-levels, 0=None to 4=Severe |
Countries
United States
Outcome results
None listed