CompletedNot Applicable

Long-term Durability Study of Collagenase Clostridium Histolyticum (CCH)

United States7 participantsStarted 2020-05-06

Plain-language summary

This study will evaluate the long-term safety and duration of efficacy of CCH in the treatment of women with cellulite. This study will be a single day evaluation, approximately 48 months after the first dose of study drug was received in the EN3835-201.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Have participated in and completed studies EN3835-201, EN3835-202 and EN3835-219 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201.
✓. Be willing and able to cooperate with the requirements of the study.

Exclusion criteria

✕. Has had retreatment with CCH in the area initially treated during the EN3835-201 study since the completion of study EN3835-219.
✕. Has received collagenase treatments (eg, Santyl® Ointment and/or Xiaflex®/Xiapex®) since the completion of study EN3835-219.
✕. Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study.
✕. Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-201 study since the completion of that study.
✕. Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.

What they're measuring

CR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study

Timeframe: Approximately 4 weeks

PR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study

Timeframe: Approximately 4 weeks

Trial details

NCT IDNCT04381117

SponsorEndo Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-06-22

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