Eligibility Details:
Inclusion Criteria:
1. Have both buttocks or both posterolateral thighs with:
1. A score of 2 or 3 (mild or moderate) as reported by the investigator using the
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
2. A Hexsel Cellulite Severity Scale (CSS) Subsection D "Grade of Laxity,
Flaccidity, or Sagging Skin" score of 0 (absence of laxity, flaccidity, or
sagging skin), or 1 (slightly draped appearance) at the Screening Visit only.
2. Be willing to apply sunscreen to the treatment areas before each exposure to the sun
for the duration of the study.
3. Be judged to be in good health.
4. Have a negative pregnancy test.
5. Be willing and able to cooperate with the requirements of the study.
Exclusion Criteria:
1. Is from a vulnerable population, as defined by the United States (US) Code of Federal
Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national
regulations, including but not limited to, employees (temporary, part-time, full-time,
etc.) or a family member of the research staff conducting the study, or of the
sponsor, or of the contract research organization, or of the Institutional Review
Board (IRB)/Independent Ethics Committee (IEC).
2. Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.
3. Has systemic conditions (coagulation disorders, malignancy, keloidal scar, abnormal
wound healing) that restricts study participation.
4. Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active
infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study
participation.
5. Has skin laxity or linear undulations on the treatment region (both buttocks or both
thighs) that can be effaced by lifting skin.
6. Has a Hexsel CSS Subsection D "Grade of laxity, flaccidity, or sagging skin" of 2
(moderate draped appearance) or 3 (severe draped appearance).
7. Requires anticoagulant or antiplatelet medication during the study.
8. Has used or intends to use any of the local
applications/therapies/injections/procedures that restricts study participation.
9. Has received any collagenase treatments at any time prior to treatment in this study
and/or has received previous treatment with EN3835 or CCH for cellulite.
10. Has received treatment with an investigational product within 30 days (or 5
half-lives, whichever is longer) of the Screening Visit.
11. Is pregnant and/or is providing breast milk or plans to become pregnant and/or to
provide breast milk during the course of the study.
12. Has any other condition(s) that, in the investigator's opinion, might indicate the
subject to be unsuitable for the study.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
