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Poly-L-Lactic Acid in Atrophic Acne Scars

Z

Zagazig University

Status

Enrolling

Conditions

Atrophic Acne Scarring

Treatments

Drug: injectable PLLA
Drug: PLLA threads

Study type

Interventional

Funder types

Other

Identifiers

NCT07523217
ZU-IRB# 212/March 2024

Details and patient eligibility

About

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.

Enrollment

52 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

52 participants in 2 patient groups

injectable PLLA
Experimental group
Treatment:
Drug: injectable PLLA
PLLA threads
Experimental group
Treatment:
Drug: PLLA threads

Trial contacts and locations

1

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Central trial contact

Reham Essam, MD

Data sourced from clinicaltrials.gov

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