Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the B… (NCT04830722) | Clinical Trial Compass
UnknownNot Applicable
Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the Buttocks and Thighs
United States20 participantsStarted 2021-04-09
Plain-language summary
clinical trial is to assess the safety, efficacy and patient satisfaction associated with the treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic
Who can participate
Age range30 Years – 60 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:
* Healthy adult females age 30 to 60
* Both buttocks and/or both posterolateral thighs with a score of mild (1-5) to moderate (6-10 according to the Hexsel, Dal'Forno \& Hexsel Cellulite Severity Scale (CSS), and a laxity score using the Hexsel, Dal'Forno \& Hexsel Cellulite Severity Scale of 1 (slight) or 2 (moderate). Must be the same score on both sides of the same area (ie: if 1 on one buttock, must be 1 on the other buttock but can be a 2 on the thigh, as long as the other thigh is also a 2)
* Must be willing to give and sign an informed consent form and photographic release form.
* Must have had a stable body weight for at least 6 months prior to study entry.
* Must be willing to maintain usual sun exposure, diet, and exercise routines for the duration of the study.
* Subject agrees to avoid tanning or use of sunless tanner during the entire course of the study.
* Negative urine pregnancy test results at the time of study entry (if applicable).
* For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment participation.
* A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
* Acceptable methods of birth control are: oral contraceptives, contraceptive patches…