Poly-L-Lactic Acid in Atrophic Acne Scars

ConditionAtrophic Acne Scarring

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-40

SponsorZagazig University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

injectable PLLA
Drug
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.
PLLA threads
Drug
On the right side of the face, PLLA threads were used in a single session. Approximately 8-10 Everline PLLA mono-threads

Treatment groups

52 Participants

are divided into 2 treatment groups

Group A: injectable PLLAExperimental treatment 1 intervention

Group B: PLLA threadsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

change in Goodman and Baron's qualitative grading score

Time frame

6 months

Sponsors and contacts

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Zagazig University

Lead sponsor

Source ClinicalTrials.gov

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