Clinical trial NCT02942160: EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Official title: A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Edematous Fibrosclerotic Panniculopathy
Cellulite
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-10-21
Enrollment: 259
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).


Eligibility criteria: Inclusion Criteria for Observation Phase:

* Voluntarily sign and date an informed consent agreement
* Have participated in and completed the double-blind study EN3835-201
* Be willing to apply sunscreen to any treated quadrant before each exposure to sun

Inclusion Criteria for Treatment Phase:

* Voluntarily sign and date an informed consent agreement
* Have participated in and completed the double-blind study EN3835-201
* Be willing to apply sunscreen to any treated quadrant before each exposure to sun
* Have at least 1 quadrant with: a score of 3 or 4 (moderate or severe) as reported on the PCSS (Photonumeric Cellulite Severity Scale) by the subject or investigator, and a Hexsel CSS (Cellulite Severity Scale) score no greater than 13
* Be judged to be in good health
* Have a negative urine pregnancy test at screening and be using an effective contraception method, be surgically sterile, or post-menopausal

Exclusion Criteria for Observation Phase:

* None

Exclusion Criteria for Treatment Phase:

* Has used, or intends to use during the course of the study, other treatment of EFP on the legs or buttocks
* Is presently nursing a baby or providing breast milk for a baby
* Intends to become pregnant during the study
* Currently receiving, has received within 7 days before injection of study drug, or plans to receive an anticoagulant or antiplatelet medication
* History of stroke or bleeding

Primary outcomes:
measure: Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
timeFrame: Day 180 to Day 360
Secondary outcomes:
measure: Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
timeFrame: Day 180 to Day 360
measure: Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
timeFrame: Day 540 to Day 720
measure: Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
timeFrame: Day 540 to Day 720
measure: CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase
timeFrame: Baseline (in EN3835-201 Study) to Observation Day 360
measure: CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
timeFrame: Day 22 to Day 360
measure: PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment
timeFrame: Day 22 to Day 360
measure: Change From Baseline on the Hexsel CSS Total Score During the Observation Phase
timeFrame: Baseline (in EN3835-201 Study) to Day 360
measure: Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits
timeFrame: Day 540 to Day 720
measure: Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment
timeFrame: Baseline - Day 360
measure: Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase
timeFrame: Day 360
measure: Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
timeFrame: Day 71 - Day 360
measure: Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360
timeFrame: Day 360
measure: Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
timeFrame: Day 71 - Day 360
measure: Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360
timeFrame: Day 360
measure: Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment
timeFrame: Day 71 - Day 360
Other outcomes:
measure: Overall Serum Antibody at Observation Visit Day 360
timeFrame: Day 360
measure: Overall Antibody Log Titer Levels at Observation Visit Day 360
timeFrame: Day 360
measure: Neutralizing Antibodies at Observation Visit Day 360
timeFrame: Day 360
measure: Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
timeFrame: Day 1 to Day 360
measure: Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment
timeFrame: Day 71 to Day 360
Locations:
city: Beverly Hills
country: United States
facility: Endo Clinical Trial Site #1
state: California
city: Murrieta
country: United States
facility: Endo Clinical Trial Site #2
state: California
city: Oceanside
country: United States
facility: Endo Clinical Trial Site #3
state: California
city: San Diego
country: United States
facility: Endo Clinical Trial Site #4
state: California
city: Clearwater
country: United States
facility: Endo Clinical Trial Site #5
state: Florida
city: Coral Gables
country: United States
facility: Endo Clinical Trial Site #6
state: Florida
city: Palm Beach
country: United States
facility: Endo Clinical Trial Site #7
state: Florida
city: Washington
country: United States
facility: Endo Clinical Trial Site #8
state: Missouri
city: New York
country: United States
facility: Endo Clinical Trial Site #10
state: New York
city: New York
country: United States
facility: Endo Clinical Trial Site #9
state: New York
city: Nashville
country: United States
facility: Endo Clinical Trial Site #11
state: Tennessee
city: Pflugerville
country: United States
facility: Endo Clinical Trial Site #12
state: Texas
city: Charlottesville
country: United States
facility: Endo Clinical Trial Site #13
state: Virginia
city: Lynchburg
country: United States
facility: Endo Clinical Trial Site #14
state: Virginia
city: Spokane
country: United States
facility: Endo Clinical Trial Site #15
state: Washington
Study officials:
affiliation: Endo Pharmaceuticals
name: Mike McLane
role: STUDY_DIRECTOR
References: