EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Status: | Completed |
---|---|
Conditions: | Cardiology, Cosmetic |
Therapuetic Areas: | Cardiology / Vascular Diseases, Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/12/2018 |
Start Date: | October 2016 |
End Date: | June 14, 2018 |
A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy
A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic
Panniculopathy (commonly known as Cellulite).
Panniculopathy (commonly known as Cellulite).
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:
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
We found this trial at
14
sites
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