Overview

This trial is active, not recruiting.

Conditions edematous fibrosclerotic panniculopathy, cellulite
Treatments collagenase clostridium histolyticum, placebo comparator
Phase phase 2
Sponsor Endo Pharmaceuticals
Start date February 2016
End date September 2016
Trial size 350 participants
Trial identifier NCT02724644, EN3835-201

Summary

The study will evaluate the safety, effectiveness, and immunogenicity of EN3835 in the treatment of adult women with Edematous Fibrosclerotic Panniculopathy (Commonly known as Cellulite).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
EN3835 0.84 mg (Collagenase Clostridium Histolyticum). Each subject can receive up to three treatment sessions. Each treatment session will be separated by approximately 21 days.
collagenase clostridium histolyticum Xiaflex
Injectable intervention
(Placebo Comparator)
Placebo
placebo comparator

Primary Outcomes

Measure
Proportion of composite responders with a 2 level improvement at Day 71
time frame: Day 71

Secondary Outcomes

Measure
Proportion of composite responders with a 1 level improvement at Day 71
time frame: Day 71
Proportion of responders with 2 levels of improvement in the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS)
time frame: Day 71
Proportion of responders with one level of improvement in the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS)
time frame: Day 71
Proportion of responders with improvement in the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS)
time frame: Day 71
Proportion of responders with one level improvement in the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS)
time frame: Day 71
Proportion of responders at each level of the Investigator Global Aesthetic Improvement Scale (I-GAIS)
time frame: Day 71
Proportion of responses at each level of the Subject Global Aesthetic Improvement Scale (S-GAIS)
time frame: Day 71
Proportion of responders at each level of the subject satisfaction with cellulite treatment assessment
time frame: Day 71
Change in the Hexsel CSS total score from day 1 (Baseline) to Day 71
time frame: Baseline and Day 71

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Be a female ≥18 years of age - At Screening visit, have at least 1 quadrant with: - a score of 3 or 4 (moderate or severe) as reported by the subject (PR- PCSS), and - a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and - a Hexsel CSS score no greater than 13 - At Day 1 visit, have an assigned quadrant with: - a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and - a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and - a Hexsel CSS score no greater than 13 - Be willing to apply sunscreen to the selected treatment quadrant before each exposure to the sun while participating in the study (ie, screening through end of study). - Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening - Have a negative urine pregnancy test at screening and be using an effective contraception method (eg, abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives, or double barrier method) for at least 1 menstrual cycle prior to study enrollment and for the duration of the study; or be menopausal defined as 12 months of amenorrhea in the absence of other biological or physiological causes, as determined by the investigator; or post-menopausal for at least 1 year; or be surgically sterile. - Be willing and able to cooperate with the requirements of the study - Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC). - Be able to read, complete and understand the Patient Reported Outcomes rating instruments in English Exclusion Criteria: - Has any of the following conditions: - Thyroid disease, unless controlled with medication for ≥6 months - Uncontrolled diabetes mellitus, as determined by the Investigator - Uncontrolled hypertension, as determined by the Investigator - Vascular disorder (eg, phlebitis or varicose veins) in area to be treated - Cushing's disease and/or use of systemic corticosteroids at a total daily dose greater than 5 mg prednisone (or equivalent) - History of lower extremity thrombosis or post-thrombosis syndrome - Documented autoimmune disorder such as lupus erythematosus, rheumatoid arthritis - Inflammation or active infection in area to be treated - Active cutaneous alteration in area to be treated including rash, eczema, psoriasis or skin cancer - History of keloidal scarring or abnormal wound healing - Coagulation disorder - Taking a medication for chronic anticoagulation (except for ≤150 mg aspirin daily)

Additional Information

Official title EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Endo Pharmaceuticals.