AcnePhase 2/3NCT07903012
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
A Phase 2/3 study testing polydioxanone (PDO) mono threads and Mono Threads with Plasma Gel in people with Acne, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate and compare the efficacy and safety of mono threads alone versus mono threads combined with plasma gel for the treatment of atrophic post-acne scars. Using a prospective, randomized, split-face design, participants receive mono threads on both sides of the face, followed one month later by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne
- What is being tested?
- polydioxanone (PDO) mono threads and Mono Threads with Plasma Gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2025to 1 Nov 2026
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older of either sex.
- Patients with bilateral atrophic post-acne scars on the face.
Who cannot join
- Active acne.
- History of keloid scarring.
- Autoimmune diseases.
- Bleeding disorders.
- Pregnancy or lactation.
- Any treatment for acne scars within the preceding 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to evaluate and compare the efficacy and safety of mono threads alone versus mono threads combined with plasma gel for the treatment of atrophic post-acne scars. Using a prospective, randomized, split-face design, participants receive mono threads on both sides of the face, followed one month later by plasma gel injection on one side and saline injection on the other. Treatment outcomes are assessed using standardized clinical photographs, the Goodman Quantitative Global Scarring Grading System, the ECCA scar grading scale, qualitative scar severity grading, and patient-reported quality of life and satisfaction measures. The study also evaluates treatment-related adverse effects, including erythema, edema, pain, and ecchymosis. The findings aim to determine whether adding plasma gel to mono threads provides greater clinical improvement and better patient-reported outcomes than mono threads with saline.
- Conditions
- Acne
- Being tested
- polydioxanone (PDO) mono threads, Mono Threads with Plasma Gel
- Keywords
- PRP
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polydioxanone (PDO) mono threadsDrug
Participants receive polydioxanone (PDO) mono threads on the assigned side of the face, followed by saline injection one month later. Six to ten threads are inserted into the mid dermis using a cross-hatch technique, according to acne scar severity.
Mono Threads with Plasma GelDrug
Also called Plasma
Participants receive polydioxanone (PDO) mono threads on the assigned side of the face, followed by plasma gel injection one month later. Six to ten threads are inserted into the mid dermis using a cross-hatch technique, according to acne scar severity. Plasma gel is subsequently injected into the mid and deep dermis and gently massaged into the skin.
| Study group | Role | What they receive |
|---|---|---|
| Mono Threads | Experimental | Participants receive polydioxanone (PDO) mono threads inserted into the mid dermis on the assigned side of the face using a cross-hatch technique. Six to ten threads are inserted according to acne scar severity. One month after thread insertion, plasma gel is injected into the mid and deep dermis and gently massaged into the skin. Clinical outcomes are assessed using standardized photographs, acne scar grading scales, and other study outcome measures. Receives: Drug: polydioxanone (PDO) mono threads |
| Mono Threads with Plasma Gel | Active comparator | Participants receive polydioxanone (PDO) mono threads on the assigned side of the face, followed by plasma gel injection one month later. Six to ten threads are inserted into the mid dermis using a cross-hatch technique, according to acne scar severity. Plasma gel is subsequently injected into the mid and deep dermis and gently massaged into the skin. Receives: Drug: Mono Threads with Plasma Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with improvement
Treatment outcome is assessed using standardized clinical photographs
Measured: 6 months
Goodman Quantitative Global Scarring Score
Change in Goodman Quantitative Global Scarring Score from baseline.
Measured: Baseline to 3 months after the final treatment session.
ECCA Scar Score
Change in the Echelle d'Évaluation Clinique des Cicatrices d'Acné (ECCA) score from baseline.
Measured: Baseline to 3 months after the final treatment session.
Qualitative Scarring Grade
Distribution of participants across mild, moderate, and severe acne scar grades.
Measured: Baseline and 3 months after the final treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start10 Nov 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AcneStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Sarsik, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903012
- Sponsor's protocol ID
- Acne PRP
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication, including relevant clinical characteristics, acne scar severity scores, clinical improvement assessments, quality-of-life assessments, patient satisfaction, and safety outcomes, will be available upon reasonable request, subject to applicable ethical and privacy requirements.
Publications
Elfar NN, Hasby EA. Efficacy and safety of plasma gel as a new modality in treatment of atrophic acne scars. Int J Dermatol. 2020 May;59(5):620-626. doi: 10.1111/ijd.14815. Epub 2020 Feb 28.
PubMed 32108322Munjal A, Ferguson N. Diversity, Equity, and Inclusion Initiatives in Dermatology Organizations. Dermatol Clin. 2023 Apr;41(2):359-369. doi: 10.1016/j.det.2022.10.008. Epub 2023 Feb 1.
PubMed 36933926
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
- ClinicalTrials.gov ID
- NCT07903012
- Acronym / sponsor ID
- Acne PRP
- Conditions
- Acne
- Keywords
- PRP
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 29 Oct 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.
This study aims to evaluate and compare the efficacy and safety of mono threads alone versus mono threads combined with plasma gel for the treatment of atrophic post-acne scars. Using a prospective, randomized, split-face design, participants receive mono threads on both sides of the face, followed one month later by plasma gel injection on one side and saline injection on the other. Treatment outcomes are assessed using standardized clinical photographs, the Goodman Quantitative Global Scarring Grading System, the ECCA scar grading scale, qualitative scar severity grading, and patient-reported quality of life and satisfaction measures. The study also evaluates treatment-related adverse effects, including erythema, edema, pain, and ecchymosis. The findings aim to determine whether adding plasma gel to mono threads provides greater clinical improvement and better patient-reported outcomes than mono threads with saline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mono Threads | Experimental | Drug: polydioxanone (PDO) mono threadsParticipants receive polydioxanone (PDO) mono threads inserted into the mid dermis on the assigned side of the face using a cross-hatch technique. Six to ten threads are inserted according to acne scar severity. One month after thread insertion, plasma gel is injected into the mid and deep dermis and gently massaged into the skin. Clinical outcomes are assessed using standardized photographs, acne scar grading scales, and other study outcome measures. |
| Mono Threads with Plasma Gel | Active comparator | Drug: Mono Threads with Plasma GelParticipants receive polydioxanone (PDO) mono threads on the assigned side of the face, followed by plasma gel injection one month later. Six to ten threads are inserted into the mid dermis using a cross-hatch technique, according to acne scar severity. Plasma gel is subsequently injected into the mid and deep dermis and gently massaged into the skin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 years or older of either sex.
- Patients with bilateral atrophic post-acne scars on the face.
Key exclusion criteria (6 listed)
- Active acne.
- History of keloid scarring.
- Autoimmune diseases.
- Bleeding disorders.
- Pregnancy or lactation.
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 |
|---|---|---|
| polydioxanone (PDO) mono threadsParticipants receive polydioxanone (PDO) mono threads on the assigned side of the face, followed by saline injection one month later. Six to ten threads are inserted into the mid dermis using a cross-hatch technique, according to acne scar severity. | Drug | Mono Threads |
| Mono Threads with Plasma GelAlso: PlasmaParticipants receive polydioxanone (PDO) mono threads on the assigned side of the face, followed by plasma gel injection one month later. Six to ten threads are inserted into the mid dermis using a cross-hatch technique, according to acne scar severity. Plasma gel is subsequently injected into the mid and deep dermis and gently massaged into the skin. | Drug | Mono Threads with Plasma Gel |
Primary outcome
Number of participants with improvement
Time frame: 6 months
Treatment outcome is assessed using standardized clinical photographs
Goodman Quantitative Global Scarring Score
Time frame: Baseline to 3 months after the final treatment session.
Change in Goodman Quantitative Global Scarring Score from baseline.
ECCA Scar Score
Time frame: Baseline to 3 months after the final treatment session.
Change in the Echelle d'Évaluation Clinique des Cicatrices d'Acné (ECCA) score from baseline.
Qualitative Scarring Grade
Time frame: Baseline and 3 months after the final treatment session.
Distribution of participants across mild, moderate, and severe acne scar grades.
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 29 Oct 2026.
- Results publication: PubMed 32108322Elfar NN, Hasby EA. Efficacy and safety of plasma gel as a new modality in treatment of atrophic acne scars. Int J Dermatol. 2020 May;59(5):620-626. doi: 10.1111/ijd.14815. Epub 2020 Feb 28.
- Results publication: PubMed 36933926Munjal A, Ferguson N. Diversity, Equity, and Inclusion Initiatives in Dermatology Organizations. Dermatol Clin. 2023 Apr;41(2):359-369. doi: 10.1016/j.det.2022.10.008. Epub 2023 Feb 1.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication, including relevant clinical characteristics, acne scar severity scores, clinical improvement assessments, quality-of-life assessments, patient satisfaction, and safety outcomes, will be available upon reasonable request, subject to applicable ethical and privacy requirements.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing polydioxanone (PDO) mono threads and Mono Threads with Plasma Gel in people with Acne, run by Tanta 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 2 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 29 Oct 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with improvement (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07903012, which also lists 2 linked publications.
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 29 Oct 2026.