CompletedPhase 2

Safety and Effectiveness of EN3835 in the Treatment of EFP in Women

United States158 participantsStarted 2017-11-17

Plain-language summary

An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women.

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Voluntarily sign and date an informed consent agreement
✓. Be a female ≥18 years of age
✓. At Screening visit, have at least 2 bilateral quadrants with each quadrant having:
✓. a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and
✓. a Hexsel CSS score no greater than 13
✓. At Day 1 visit, have assigned bilateral quadrants with each quadrant having:
✓. a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and
✓. a Hexsel CSS score no greater than 13

✕. Has any of the following systemic conditions:
✕. Coagulation disorder
✕. Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there has been no recurrence in at least 5 years
✕. History of keloidal scarring or abnormal wound healing
✕. Concurrent diseases or conditions that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. Any questions about concurrent diseases should be discussed with the Medical Monitor.
✕. Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values.
✕. Has any of the following local conditions in the area to be treated:
✕. History of lower extremity thrombosis or post-thrombosis syndrome

Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders

Timeframe: Day 22, 43, 90, and 180

NCT IDNCT03329989

SponsorEndo Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09-05

Results submitted2020-08-05

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Voluntarily sign and date an informed consent agreement
✓. Be a female ≥18 years of age
✓. At Screening visit, have at least 2 bilateral quadrants with each quadrant having:
✓. a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and
✓. a Hexsel CSS score no greater than 13
✓. At Day 1 visit, have assigned bilateral quadrants with each quadrant having:
✓. a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and
✓. a Hexsel CSS score no greater than 13

✕. Has any of the following systemic conditions:
✕. Coagulation disorder
✕. Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there has been no recurrence in at least 5 years
✕. History of keloidal scarring or abnormal wound healing
✕. Concurrent diseases or conditions that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. Any questions about concurrent diseases should be discussed with the Medical Monitor.
✕. Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values.
✕. Has any of the following local conditions in the area to be treated:
✕. History of lower extremity thrombosis or post-thrombosis syndrome