CompletedNot Applicable

Durability and Safety of CCH With Two Different Injection Techniques in Cellulite With Laxity

United States20 participantsStarted 2022-01-25

Plain-language summary

All participants who completed the EN3835-224 study will be invited to participate in this observational study to evaluate long term durability of response and safety.

Who can participate

Age range18 Years – 55 Years

SexFEMALE

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Inclusion criteria

✓. Have participated in and completed study EN3835-224 (parent study).
✓. Be willing and able to cooperate with the requirements of the study.

Exclusion criteria

✕. Has received any collagenase treatments (eg, Santyl® Ointment) at any time since
✕. Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-224 study since the completion of that study.
✕. Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study

What they're measuring

Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh

Timeframe: Day 360

Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh

Timeframe: Day 540

Trial details

NCT IDNCT05249257

SponsorEndo Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-09-12

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