EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

Endo Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Cellulite; Edematous Fibrosclerotic Panniculopathy

Treatments: Biological: Collagenase Clostridium Histolyticum

Study type: Interventional

Funder types: Industry

Identifiers

NCT02942160

EN3835-202

Details and patient eligibility

About

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

Enrollment: 259 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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259 participants in 1 patient group

EN3835 Active

Experimental group

Description:

EN3835 0.84mg (Collagenase Clostridium Histolyticum)

Treatment:

Biological: Collagenase Clostridium Histolyticum