CompletedPhase 3

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

United States483 participantsStarted 2018-04-26

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 and/or tanning booths while participating in the study
✓. Be judged to be in good health
✓. Be willing and able to cooperate with the requirements of the study
✓. Be able to read, complete and understand the participant reported outcomes rating instruments in English.

Exclusion criteria

✕. Intends to or has used any of the local applications/therapies/injections/procedures that restricts study participation
✕. Intends to use tanning spray or tanning booths during this period
✕. Has received or intends to receive an investigational drug or treatment, other than the treatment received in study EN3835-302/303 during this period
✕. Any other condition(s) that, in the Investigator's opinion, might indicate the participant to be unsuitable for the study

What they're measuring

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to Day 1080

Percentage of Participants Who Were Seropositive for Anti-Drug Antibodies (ADAs) After CCH-aaes Treatment

Timeframe: From Day 180 (Open-label Phase) up to Day 1080

Trial details

NCT IDNCT03526549

SponsorEndo Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-08

Results submitted2022-10-07

View on ClinicalTrials.gov More Edematous Fibrosclerotic Panniculopathy trials