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

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.

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Key information

Conditions

Edematous Fibrosclerotic Panniculopathy Cellulite Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Endo Clinical Trial Site #4, Clearwater, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To qualify for the study a subject must:

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).
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.
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:

Has had retreatment with EN3835 in the area initially treated during the EN3835-201 study since the completion of study EN3835-202.
Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study.
Has had any of the following in the area initially treated during the EN3835-201 study since the completion of that study.

Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision and/or powered subcision).
Any investigational treatment for EFP/cellulite.
Endermologie® or similar treatments.
Massage therapy.
Creams (eg, Celluvera™, TriLastin®).
Any other condition(s) that, in the Investigator's opinion, might indicate the subject is unsuitable for the study.

Treatment and study plan

Previously Treated with EN3835

Biological

No treatment to be administered - Observational only

Primary outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Mar 28, 2019
Registry last updated: Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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