Durability and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women

Edematous Fibrosclerotic Panniculopathy Clinical Trial

Official title:

A Phase 2b, Open Label Durability Study of EN3835 Following Treatment of Edematous Fibrosclerotic Panniculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03893890
• Other study ID #: EN3835-219
• Status: Completed
• Start date: March 28, 2019
• Est. completion date: June 25, 2019

Study information

• Verified date: July 2019
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 25, 2019
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Edematous Fibrosclerotic Panniculopathy

Intervention

Biological:
• Previously Treated with EN3835
No treatment to be administered - Observational only

Locations

Country	Name	City	State
United States	Endo Clinical Trial Site #3	Charlottesville	Virginia
United States	Endo Clinical Trial Site #4	Clearwater	Florida
United States	Endo Clinical Trial Site #1	Coral Gables	Florida
United States	Endo Clinical Trial Site #2	New York	New York
United States	Endo Clinical Trial Site #5	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 EN3835-201 study in CR-PCSS Scale is 5-levels, 0=None to 4=Severe	Change from baseline (pre-dose, Day 1) of response to treatment, approximately 3 years post treatment in EN3835-201 Study
Primary	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 EN3835-201 study in PR-PCSS Scale is 5-levels, 0=None to 4=Severe	Change from baseline (pre-dose, Day 1) of response to treatment, approximately 3 years post treatment in EN3835-201 Study
Primary	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) of EN3835-201 study in CR-PCSS Scale is 5-levels, 0=None to 4=Severe	Change from reference time point (Day 71), approximately 3 years post treatment in EN3835-201 Study
Primary	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) of EN3835-201 study in PR-PCSS Scale is 5-levels, 0=None to 4=Severe	Change from reference time point (Day 71), approximately 3 years post treatment in EN3835-201 Study