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Long-Term Study of EN3835 in Edematous Fibrosclerotic Panniculopathy (Cellulite)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03526549
Recruitment Status : Enrolling by invitation
First Posted : May 16, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:
A Phase 3b, Open-Label Extension Study to evaluate safety and how long response of EN3835 lasts in the treatment of Cellulite.

Condition or disease Intervention/treatment Phase
Edematous Fibrosclerotic Panniculopathy Cellulite Biological: EN3835 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: EN3835 Active
EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
Biological: EN3835
Collagenase Clostridium Histolyticum (CCH)
Other Name: Xiaflex




Primary Outcome Measures :
  1. Proportion of subjects who lose their response as compared to Day 71 of EN3835-302/303 [ Time Frame: 60 months ]
    Measured by proportion of subjects that both the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) scores/ratings return to baseline of the double-blind studies (EN3835-302/303) or worse; both CR-PCSS and PR-PCSS worsened 2-levels compared to the score at Day 71 of the double-blind studies (EN3835-302/303); either CR-PCSS or PR-PCSS worsened 2-levels compared to the scores at Day 71 of the double-blind studies (EN3835-302/303); both CR-PCSS and PR-PCSS scores worsened by 1-level compared to the corresponding scores at Day 71 of the double-blind studies (EN3835-302/303)


Secondary Outcome Measures :
  1. Proportion of subjects at each level of improvement in the PR-PCSS [ Time Frame: 60 months ]
    Scale is 5 levels, 0=None to 4=Severe

  2. Proportion of subjects at each level of improvement in the CR-PCSS [ Time Frame: 60 months ]
    Scale is 5 levels, 0=None to 4=Severe

  3. Changes in the Patient Reported Cellulite Impact Scale (PR-CIS) from Baseline (Day 1) of EN3835-302/303 [ Time Frame: 60 months ]
    Scale is 11 levels; 0=Not at All to 10=Extremely

  4. Proportion of subjects at each level of improvement in the Subject Satisfaction with cellulite treatment [ Time Frame: 60 months ]
    Scale is 5 levels; -2=Very dissatisfied to +2=Very satisfied

  5. Proportion of subjects at each level of improvement in the subject self-rating scale [ Time Frame: 60 months ]
    Scale is 7 levels; 0=Extremely dissatisfied to 6=Extremely satisfied



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526549


  Show 45 Study Locations
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Michael McLane, PhD Endo Pharmaceuticals

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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03526549     History of Changes
Other Study ID Numbers: EN3835-304
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cellulite
Edema
Skin Manifestations
Signs and Symptoms