Atrophic Acne ScarringNCT07523217
Poly-L-Lactic Acid in Atrophic Acne Scars
A study testing injectable PLLA and PLLA threads in people with Atrophic Acne Scarring, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophic Acne Scarring
- What is being tested?
- injectable PLLA and PLLA threads
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2026to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University Hospitals
Zagazig, Sharqia Province, 2543
Reham Essam, 01097709477, rereessam22@gmail.com
About this study
Official title: Poly-L-Lactic Acid: A Comparative Study of Injectable and Thread-Based Delivery in Atrophic Acne Scars
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
- Atrophic Acne Scarring
- Being tested
- injectable PLLA, PLLA threads
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectable PLLADrug
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 threadsDrug
On the right side of the face, PLLA threads were used in a single session. Approximately 8-10 Everline PLLA mono-threads
| Study group | Role | What they receive |
|---|---|---|
| injectable PLLA | Experimental | Not described Receives: Drug: injectable PLLA |
| PLLA threads | Experimental | Not described Receives: Drug: PLLA threads |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Goodman and Baron's qualitative grading score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 Mar 2026
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic Acne ScarringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Essam, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523217
- Sponsor's protocol ID
- ZU-IRB# 212/March 2024
- Status last verified
- Sep 2026
- First submitted
- 3 Apr 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Poly-L-Lactic Acid: A Comparative Study of Injectable and Thread-Based Delivery in Atrophic Acne Scars
- ClinicalTrials.gov ID
- NCT07523217
- Acronym / sponsor ID
- ZU-IRB# 212/March 2024
- Conditions
- Atrophic Acne Scarring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| injectable PLLA | Experimental | Drug: injectable PLLA |
| PLLA threads | Experimental | Drug: PLLA threads |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injectable PLLAThe 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 | injectable PLLA |
| PLLA threadsOn the right side of the face, PLLA threads were used in a single session. Approximately 8-10 Everline PLLA mono-threads | Drug | PLLA threads |
Primary outcome
change in Goodman and Baron's qualitative grading score
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injectable PLLA and PLLA threads in people with Atrophic Acne Scarring, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reham Essam, MD (+201097709477, rereessam22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Goodman and Baron's qualitative grading score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.