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RecruitingNCT07523217Updated Sep 18, 2026

Poly-L-Lactic Acid in Atrophic Acne Scars

An interventional study of injectable PLLA and PLLA threads in Atrophic Acne Scarring, sponsored by Zagazig University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Zagazig University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Atrophic Acne Scarring
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    injectable PLLA

    Drug: injectable PLLA

  • Experimental
    PLLA threads

    Drug: PLLA threads

Interventions

  • Druginjectable 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.

  • DrugPLLA threads

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

05

What researchers measure

Primary outcomes

  1. change in Goodman and Baron's qualitative grading score

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • Zagazig University Hospitals
    Zagazig, Sharqia Province 2543, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07523217
Lead sponsor
Zagazig University
Responsible party
Reham Essam (Ass.prof, Zagazig University) — Principal investigator
First posted
Apr 13, 2026
Start date
Mar 15, 2026
Primary completion
Mar 15, 2027 (estimated)
Completion
Mar 15, 2027 (estimated)
Last update
Sep 18, 2026

Study contacts

Reham Essam, MD
Contact
rereessam22@gmail.com
+201097709477

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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