Poly-L-Lactic Acid in Atrophic Acne Scars
Poly-L-Lactic Acid: A Comparative Study of Injectable and Thread-Based Delivery in Atrophic Acne Scars
1 other identifier
interventional
52
1 country
1
Brief Summary
Background: Management of atrophic acne scars remains challenging due to their heterogeneous morphology and suboptimal response to conventional therapies. Poly-L-lactic acid (PLLA), a biostimulatory agent, promotes neocollagenesis and has emerged as a promising therapeutic option. However, comparative data on different delivery modalities of PLLA and their effects on dermal remodeling and skin physiology remain limited. Objective: To compare two delivery modalities of PLLA (injectable versus mono-thread) and evaluate their effects on dermal remodeling, clinical outcomes, and safety in atrophic acne scars. Methods: This prospective split-face study included 24 patients with atrophic acne scars. The right facial side was treated with a single session of PLLA mono-threads, while the left side received two sessions of injectable PLLA at 6-week intervals. Clinical outcomes were assessed using Goodman and Baron's qualitative and quantitative grading systems over a 3-month follow-up period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2024
CompletedFirst Submitted
Initial submission to the registry
April 3, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 15, 2027
April 13, 2026
April 1, 2026
3 years
April 3, 2026
April 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
change in Goodman and Baron's qualitative grading score
6 months
Study Arms (2)
injectable PLLA
EXPERIMENTALPLLA threads
EXPERIMENTALInterventions
The vial was reconstituted with 8 mL of bacteriostatic sterile water for injection (BSWFI). After at least 2 hours, 2 mL of lidocaine (1-2%) with epinephrine was added, making the total solution volume 10 mL. One hour later, the vial was gently shaken, and the syringes were prepared for injection. The injection was given using 28-G needles beneath each scar with a serial injection technique during each session.
On the right side of the face, PLLA threads were used in a single session. Approximately 8-10 Everline PLLA mono-threads
Eligibility Criteria
You may qualify if:
- included adult patients (≥18 years) of both sexes presenting with clinically diagnosed atrophic acne scars (Grades 2-4 according to the Goodman and Baron classification)
You may not qualify if:
- active acne lesions, pregnancy or lactation, bleeding disorders, keloid tendency, systemic diseases affecting wound healing, recent acne scar treatment within the past six months, and known hypersensitivity to PLLA components.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zagazig University Hospitals
Zagazig, Sharqia Province, 2543, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass.prof
Study Record Dates
First Submitted
April 3, 2026
First Posted
April 13, 2026
Study Start
March 15, 2024
Primary Completion (Estimated)
March 15, 2027
Study Completion (Estimated)
March 15, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04