CompletedNot Applicable

Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite

Canada29 participantsStarted 2021-11-19

Plain-language summary

This pilot study has been designed to evaluate the safety and effectiveness of PLLA as a single regimen for the improvement in appearance of cellulite after changes in reconstitution procedure.

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.

Exclusion criteria

✕. Previous permanent implant, filler, lifting threads, or autologous fat in the treatment area, regardless of time.
✕. Previous semi-permanent implants exemplified by Calcium Hydroxylapatite (CaHA), poly l-lactic acid (PLLA) in treatment area, regardless of time.
✕. Previous Hyaluronic acid (HA) filler or collagen filler in the treatment area within 12 months.
✕. Previous energy based aesthetic procedures (e.g. laser, intense pulsed light, radiofrequency and endermology) in the treatment area within 6 months.
✕. Previous mechanical (e.g. dermabrasion, needling) or chemical aesthetic procedures (e.g. chemical peel) in the treatment area within 6 months.
✕. Previous treatment with cryotherapy, lipolytic treatments or liporeduction massage in the treatment area within 6 months.

What they're measuring

Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9

Timeframe: At Month 9

Trial details

NCT IDNCT05064761

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-21

Results submitted2024-06-14

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