Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite)
NCT ID: NCT03526549
Last Updated: 2023-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
483 participants
INTERVENTIONAL
2018-04-26
2021-10-08
Brief Summary
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Detailed Description
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In the Open-label Phase of the study, all participants who qualified for, and opted for, retreatment were administered CCH-aaes at 3 treatment sessions at 21-day intervals.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
CCH-aaes retreatment in this study was provided in an open-label manner.
Study Groups
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CCH-aaes Treatment in Parent Studies (EN3835-302/303)
Participants who received CCH-aaes treatment in EN3835-302/303 were followed for 180 days of observation with no treatment. Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase and entered the Open-label Phase of the study. Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals.
CCH-aaes
Administered to participants who qualified for, and opted for, retreatment.
Observation
No treatment administered during 180 days of observation.
Placebo Treatment in Parent Studies (EN3835-302/303)
Participants who received placebo in the parent studies, were followed for 180 days of observation with no treatment. After Day 180, all participants who received placebo during the double-blind parent studies were discontinued. No treatment was administered.
Observation
No treatment administered during 180 days of observation.
Interventions
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CCH-aaes
Administered to participants who qualified for, and opted for, retreatment.
Observation
No treatment administered during 180 days of observation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Voluntarily sign and date an informed consent agreement
2. Have participated in and completed the double-blind Phase 3 study EN3835-302 or EN3835-303
3. Be willing to apply sunscreen to the buttocks before each exposure to the sun and/or tanning booths while participating in the study
4. Be judged to be in good health
5. Be willing and able to cooperate with the requirements of the study
6. Be able to read, complete and understand the participant reported outcomes rating instruments in English.
1\. Have a negative pregnancy test and using a stable and effective contraception method.
Exclusion Criteria
1. Intends to or has used any of the local applications/therapies/injections/procedures that restricts study participation
2. Intends to use tanning spray or tanning booths during this period
3. Has received or intends to receive an investigational drug or treatment, other than the treatment received in study EN3835-302/303 during this period
4. Any other condition(s) that, in the Investigator's opinion, might indicate the participant to be unsuitable for the study
1\. Has received any collagenase treatments at any time since completion of the double-blind study (EN3835-302 or EN3835-303).
1\. Has systemic conditions (coagulation disorders, malignancy, keloidal scar, abnormal wound healing) that restricts study participation
* Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, skin laxity, flaccidity and/or skin sagging, active cutaneous alteration, tattoo/mole) that restricts study participation
* Requires anticoagulant or antiplatelet medication during the study
* Prior to and during the course of retreatment, is nursing or providing breast milk in any manner, intends to become pregnant during the study, or intends to use tanning spray or tanning booths during the study
* Has received an investigational drug or treatment, other than treatment in study EN3835-302/303, within 30 days before retreatment with study drug
* Has a known systemic allergy to collagenase or any other excipient of study drug
* Has received any collagenase treatments at any time since completion of the double-blind study
* Any other condition(s) that, in the Investigator's opinion, might indicate the participant to be unsuitable for retreatment
18 Years
FEMALE
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Karen Chajko
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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Endo Clinical Trial Site #3
Glendale, Arizona, United States
Endo Clinical Trial Site #11
Scottsdale, Arizona, United States
Endo Clinical Trial Site #41
North Little Rock, Arkansas, United States
Endo Clinical Trial Site #14
Encinitas, California, United States
Endo Clinical Trial Site #9
Long Beach, California, United States
Endo Clinical Trial Site #35
Murrieta, California, United States
Endo Clinical Trial Site #42
Newport Beach, California, United States
Endo Clinical Trial Site #17
Oceanside, California, United States
Endo Clinical Trial Site #39
San Diego, California, United States
Endo Clinical Trial Site #23
Greenwood Village, Colorado, United States
Endo Clinical Trial Site #38
Boca Raton, Florida, United States
Endo Clinical Trial Site #8
Coral Gables, Florida, United States
Endo Clinical Trial Site #40
Largo, Florida, United States
Endo Clinical Trial Site #27
Miami, Florida, United States
Endo Clinical Trial Site #36
Miami, Florida, United States
Endo Clinical Trial Site #20
Snellville, Georgia, United States
Endo Clinical Trial Site #19
Meridian, Idaho, United States
Endo Clinical Trial Site #34
Chicago, Illinois, United States
Endo Clinical Trial Site #30
Indianapolis, Indiana, United States
Endo Clinical Trial Site #16
Metairie, Louisiana, United States
Endo Clinical Trial Site #10
New Orleans, Louisiana, United States
Endo Clinical Trial Site #25
New Orleans, Louisiana, United States
Endo Clinical Trial Site #33
Quincy, Massachusetts, United States
Endo Clinical Trial Site #18
Washington, Missouri, United States
Endo Clinical Trial Site #4
Omaha, Nebraska, United States
Endo Clinical Trial Site #24
Mount Kisco, New York, United States
Endo Clinical Trial Site #32
New York, New York, United States
Endo Clinical Trial Site #12
New York, New York, United States
Endo Clinical Trial Site #15
New York, New York, United States
Endo Clinical Trial Site #29
New York, New York, United States
Endo Clinical Trial Site #26
Cincinnati, Ohio, United States
Endo Clinical Trial Site #5
Nashville, Tennessee, United States
Endo Clinical Trial Site #22
Austin, Texas, United States
Endo Clinical Trial Site #6
Beaumont, Texas, United States
Endo Clinical Trial Site #13
Houston, Texas, United States
Endo Clinical Trial Site #7
Houston, Texas, United States
Endo Clinical Trial Site #28
Pflugerville, Texas, United States
Endo Clinical Trial Site #21
San Antonio, Texas, United States
Endo Clinical Trial Site #37
Sugar Land, Texas, United States
Endo Clinical Trial Site #31
Salt Lake City, Utah, United States
Endo Clinical Trial Site #1
Charlottesville, Virginia, United States
Endo Clinical Trial Site #2
Lynchburg, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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EN3835-304
Identifier Type: -
Identifier Source: org_study_id
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