Trials / Recruiting
RecruitingNCT07523217
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- Sponsor
- Zagazig University · Other Government
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-03-15
- Primary completion
- 2027-03-15
- Completion
- 2027-03-15
- First posted
- 2026-04-13
- Last updated
- 2026-04-13
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT07523217. Inclusion in this directory is not an endorsement.