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Recruiting NCT07523217

Poly-L-Lactic Acid in Atrophic Acne Scars

No phase Interventional Atrophic Acne Scarring

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: injectable PLLA, PLLA threads.
Who it may be relevant to
Registry conditions: Atrophic Acne Scarring. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Poly-L-Lactic Acid: A Comparative Study of Injectable and Thread-Based Delivery in Atrophic Acne Scars

Overview

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.

Interventions

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

Primary outcome measures

  • change in Goodman and Baron's qualitative grading score [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Zagazig University Hospitals — Zagazig

Identifiers

NCT: NCT07523217 · ZU-IRB# 212/March 2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗