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

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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.


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
2095 Langhorne Road
Lynchburg, Virginia 24501
434-847-8400
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Lynchburg, VA
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3420 Fannin
Beaumont, Texas 77701
409-813-1190
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Beaumont, TX
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911 Park Avenue
New York, New York 10075
212-710-9855
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New York, NY
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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San Antonio, TX
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Austin, Texas 78759
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Austin, TX
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Boca Raton, Florida 33486
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Boca Raton, FL
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Carmel, IN
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Charlottesville, Virginia 22911
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Charlottesville, VA
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Chestnut Hill, Massachusetts 02467
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Chicago, IL
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Cincinnati, Ohio 45249
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Cincinnati, OH
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Coral Gables, Florida 33146
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Coral Gables, FL
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Encinitas, CA
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Encino, CA
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Glendale, Arizona 85308
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Glendale, AZ
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Greenwood Village, Colorado 80113
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Greenwood Village, CO
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6400 Fannin Street
Houston, Texas 77056
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Houston, TX
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23510 Kingsland Boulevard
Houston, Texas 77494
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Houston, TX
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4700 North Habana Avenue
Largo, Florida 33770
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Largo, FL
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Long Beach, California 90806
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Meridian, Idaho 83642
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Meridian, ID
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Metairie, LA
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4500 Biscayne Boulevard
Miami, Florida 33137
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Miami, Florida 33175
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Miami, FL
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Montclair, New Jersey 07042
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Montclair, NJ
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359 East Main Street
Mount Kisco, New York 10549
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Mount Kisco, NY
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Murrieta, California 92562
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Murrieta, CA
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Nashville, Tennessee 37215
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New Orleans, Louisiana 70124
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New Orleans, LA
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New York, New York 10022
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New York, New York 10065
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317 East 34th Street
New York, New York 10016
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Newport Beach, California 92663
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Newport Beach, CA
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4137 J.F.K. Boulevard
North Little Rock, Arkansas 72116
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North Little Rock, AR
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Oceanside, California 92056
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Oceanside, CA
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Omaha, Nebraska 68144
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Omaha, NE
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Pflugerville, TX
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Quincy, Massachusetts 02169
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Quincy, MA
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440 West 200 South
Salt Lake City, Utah 84101
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Salt Lake City, UT
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San Diego, CA
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Scottsdale, Arizona 85258
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2383 Pate Street North
Snellville, Georgia 30078
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Sugar Land, Texas 77497
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Sugar Land, TX
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Washington, Missouri 63090
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Washington, MO
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