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

This is an interventional treatment trial for Edematous Fibrosclerotic Panniculopathy Read More

Inclusion Criteria

All Subjects (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 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 subject reported outcomes rating instruments in English.

In addition to inclusion Criteria for All Subjects Through Day 180, additional Inclusion Criteria are listed below:

Inclusion Criteria - Category I Subjects:

1. Received active EN3835 in study EN3835-302 or EN3835-303
2. Maximum composite response at Day 71 in either or both buttocks in double-blind study EN3835-302 or EN3835-303 was ONLY a 1-level improvement on CR-PCSS/PR-PCSS

Inclusion Criteria - Category II Subjects:

1. Received active EN3835 in study EN3835-302 or EN3835-303
2. Maximum composite response at Day 71 in either or both buttocks in double-blind study EN3835-302 or EN3835-303 was at least a 2-level composite improvement on CR-PCSS/PR-PCSS

Inclusion Criteria - Category III Subjects:

1. Received active EN3835 in study EN3835-302 or EN3835-303 but did not meet eligibility criteria for Category I or Category II status

Inclusion Criteria - Retreatment Subjects (Eligible Category I and Category II Subjects Whom opt to Receive Retreatment):

1. Have a negative serum pregnancy test

Exclusion Criteria

All Subjects (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 subject to be unsuitable for the study

In addition to Exclusion Criteria for All Subjects Through Day 180, additional Exclusion Criteria also apply to Category I and Category II subjects:

Exclusion Criteria - Category I and Category II Subjects (Post Day 180):

1. Has received any collagenase treatments at any time since completion of the double-blind study (EN3835-302 or EN3835-303).

Exclusion Criteria for Subjects Whom opt for Observations Only (ie, no retreatment): None

Exclusion Criteria - Category II Subjects:

Exclusion criteria for Subjects Whom opt for Observation Only (ie, no retreatment): None

Exclusion Criteria - Category III Subjects: None

Exclusion Criteria - Retreatment Subjects (Eligible Category I and Category II Subjects Whom opt to Receive Retreatment):

1. Has systemic conditions (coagulation disorders, malignancy, keloidal scar, adnormal wound healing) that restricts study participation
2. 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
3. Requires anticoagulant or antiplatelet medication during the study
4. Prior to and during the course of retreatment (Treatment Visit 1 through Treatment Visit 4), is nursing or providing breast milk in any manner
5. Prior to and during the course of retreatment (Treatment Visit 1 through Treatment Visit 4), intends to become pregnant during the study
6. Prior to and during the course of retreatment (Treatment Visit 1 through Treatment Visit 4), intends to use tanning spray or tanning booths during the study
7. Has received an investigational drug or treatment, other than treatment in study EN3835-302/303, within 30 days before retreatment with study drug
8. Has a known systemic allergy to collagenase or any other excipient of study drug
9. Has received any collagenase treatments at any time since completion of the double-blind study
10. Any other condition(s) that, in the Investigator's opinion, might indicate the subject to be unsuitable for Category II retreatment