Clinical trial NCT03893890: Durability and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women
Official title: A Phase 2b, Open Label Durability Study of EN3835 Following Treatment of Edematous Fibrosclerotic Panniculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edematous Fibrosclerotic Panniculopathy
Keywords: Edematous Fibrosclerotic Panniculopathy
EFP
Cellulite
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-03-28
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 8 subjects who completed the EN3835-201 and EN3835-202 studies and who had a composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in the EN3835-201 study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Change from baseline (pre-dose, Day 1) of response to treatment, approximately 3 years post treatment in EN3835-201 Study
measure: 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)
timeFrame: Change from baseline (pre-dose, Day 1) of response to treatment, approximately 3 years post treatment in EN3835-201 Study
measure: 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)
timeFrame: Change from reference time point (Day 71), approximately 3 years post treatment in EN3835-201 Study
measure: 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)
timeFrame: Change from reference time point (Day 71), approximately 3 years post treatment in EN3835-201 Study
Secondary outcomes:
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Endo Clinical Trial Site #4
state: Florida
city: Coral Gables
country: United States
facility: Endo Clinical Trial Site #1
state: Florida
city: Washington
country: United States
facility: Endo Clinical Trial Site #5
state: Missouri
city: New York
country: United States
facility: Endo Clinical Trial Site #2
state: New York
city: Charlottesville
country: United States
facility: Endo Clinical Trial Site #3
state: Virginia
Study officials:
affiliation: Endo Pharmaceuticals
name: Karen Chajko
role: STUDY_DIRECTOR
References: