Long-Term Study of EN3835 in Edematous Fibrosclerotic Panniculopathy (Cellulite)
Status: | Enrolling by invitation |
---|---|
Conditions: | Cardiology, Cosmetic |
Therapuetic Areas: | Cardiology / Vascular Diseases, Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/15/2018 |
Start Date: | April 26, 2018 |
End Date: | October 2023 |
A Phase 3b, Open-Label, Long-Term Study to Evaluate the Safety and Temporal Pattern of Response of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy
A Phase 3b, Open-Label Extension Study to evaluate safety and how long response of EN3835
lasts in the treatment of Cellulite.
lasts in the treatment of Cellulite.
Inclusion Criteria through Day 180:
- Voluntarily sign and date an informed consent agreement
- Have participated in and completed the double-blind Phase 3 study EN3835-302 or
EN3835-303
- Be willing to apply sunscreen to the buttocks before each exposure to the sun while
participating in the study during this period
- Be judged in good health
- Have a negative serum pregnancy test and be using an effective method of birth control
Inclusion Criteria beyond Day 180
- Received active EN3835 in the double-blind studies (EN3835-302/303) and not placebo
- Be willing to apply sunscreen to the buttocks before each exposure to sun while
participating in any re-treatment portion of the study.
- Have a negative urine pregnancy test and use an effective method of birth control, as
appropriate
Exclusion Criteria through Day 180:
- Intends to or has used other treatments for EFP on the buttocks at any time during the
study
- Intends to use tanning spray or tanning booths during the study
Exclusion Criteria beyond Day 180:
- Intends to or has used other treatments for EFP on the buttocks at any time during the
study
- Intends to use tanning spray or tanning booths during the study
We found this trial at
45
sites
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2095 Langhorne Road
Lynchburg, Virginia 24501
Lynchburg, Virginia 24501
434-847-8400
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4137 J.F.K. Boulevard
North Little Rock, Arkansas 72116
North Little Rock, Arkansas 72116
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440 West 200 South
Salt Lake City, Utah 84101
Salt Lake City, Utah 84101
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