Clinical trial NCT05064761: Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite
Official title: A Pilot Study to Evaluate Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cellulite
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2021-10-01
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Cellulite is a topographic and localized skin condition that is commonly found on the posterolateral thighs, buttocks, and abdomen. It is often identified by a dimpled or orange-peel appearance of the skin's surface. The presence of visible cellulite is associated with histologic changes in the dermis, adipose tissue, and septae.

Based on the theory that a stronger skin structure, with a decrease in skin laxity and increase in dermal thickness, could reduce the appearance of cellulite, the Sponsor intends to investigate the safety and effectiveness of PLLA for the improvement in appearance of cellulite in the posterior thighs.

Eligibility criteria: Inclusion Criteria:

* Subjects with intent to undergo treatment to improve appearance of cellulite in the posterior thighs.

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any of the Sculptra constituents.
* Known/previous allergy or hypersensitivity to lidocaine and other local anesthetics, e.g. amide-type anesthetics, or topical anesthetics or nerve blocking agents.
* Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
* Previous treatment/procedure in or near the treatment area:

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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
timeFrame: At month 1, 2, 6 and 12
measure: Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
timeFrame: At Months 1, 2, 6, 9 and 12
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Galderma Research Site
state: British Columbia
Study officials:
affiliation: Galderma R&D
name: Study Director
role: STUDY_DIRECTOR
References: