Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite)
Condition: Edematous Fibrosclerotic Panniculopathy; Cellulite
MeSH terms: Cellulite; Edema
Intervention: CCH-aaes; Observation
Intervention description: Administered to participants who qualified for, and opted for, retreatment.; No treatment administered during 180 days of observation.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Investigators, participants, and site personnel were blinded to the treatment administered in the EN3835-302/303 parent studies until all Day 180 visit assessments were completed.
CCH-aaes retreatment in this study was provided in an open-label manner.
Enrollment: 483.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Phase 3b, Open-Label Extension Study to evaluate safety and how long response of EN3835
      (Collagenase Clostridium Histolyticum [CCH]-aaes) lasts in the treatment of Cellulite.
    

Eligibility criteria:

        Key Inclusion Criteria

        All Participants (Through Day 180):

          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.

        Key Inclusion Criteria for Participants Eligible for Retreatment:

        1. Have a negative pregnancy test and using a stable and effective contraception method.

        Key Exclusion Criteria

        All Participants (Through Day 180):

          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

        Additional Exclusion Criteria may apply Post Day 180:

        1. Has received any collagenase treatments at any time since completion of the double-blind
        study (EN3835-302 or EN3835-303).

        Key Exclusion Criteria for Participants Eligible for Retreatment:

        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