Atrophic Acne ScarPhase 2NCT06227481
Combined Procedures in the Treatment of Severe Acne Scars
A Phase 2 study testing Scar subcision, Platelet rich plasma injection and Polydioxanone mono threads insertion in people with Atrophic Acne Scar, run by Al-Azhar University.
Trial summary
Many methods utilize for acne scar treatment including laser, cosmetic filler, microneedling, local tumescent, Subcision and chemical peels. These procedures can be used individually or as a combination therapy. Combining procedures give better results. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Atrophic Acne Scar
- What is being tested?
- Scar subcision, Platelet rich plasma injection and Polydioxanone mono threads insertion
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- Patients with severe atrophic acne scars (as per Goodman and Baron's acne qualitative scar grading scale)
Who cannot join
- Patients with active acne lesions.
- Patients having a keloid formation tendency.
- Patients with a history of bleeding disorder or severe anemia.
- Pregnant or lactating women.
- Patients received any treatment for scars in the last 6 months.
- Patients using drugs causing photosensitivity or systemic retinoids in the previous 6 months (for laser group).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficiency Of Combination Of Scar Subcision With Platelet Rich Plasma, Polydioxanone Mono Threads Or Fractional Carbon Dioxide Laser In The Treatment Of Severe Atrophic Acne Scars: A Randomized Controlled Study
Many methods utilize for acne scar treatment including laser, cosmetic filler, microneedling, local tumescent, Subcision and chemical peels. These procedures can be used individually or as a combination therapy.
Combining procedures give better results. In our study we will try in the period from March 2024 to March 2026, to assess the efficacy of combination of scar subcision with platelet rich plasma, Polydioxanone mono threads or fractional Carbon dioxide laser in the treatment of severe atrophic acne scars with 1:1:1 ratios and to compare between these modalities regarding safety and efficacy.
Read the detailed description
This is a prospective controlled trial that will be conducted at Dermatology, venereology, and andrology Department, Al-Azhar university hospital, Assiut, in the period from March 2024 to March 2026, to assess the efficacy of combination of scar subcision with platelet rich plasma , polydioxanone mono threads or fractional carbon dioxide laser in the treatment of severe atrophic acne scars with 1:1:1 ratios and to compare between these modalities regarding safety and efficacy
- Conditions
- Atrophic Acne Scar
- Being tested
- Scar subcision, Platelet rich plasma injection, Polydioxanone mono threads insertion, Fractional carbon dioxide laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scar subcisionProcedure or surgery
- Subcision will be performed with18 gauge cannula at the margin of the scars on both sides of the face.
- The cannula will be directed in a forward and backward motion producing a tunnel. Then, the it will be passed in sideways in a sweeping action to freeing up the scars from their bases.
- Once finish, the pressure will be applied to reduce the bleeding and swelling. The topical antibiotic will be applied for 3 days.
Platelet rich plasma injectionProcedure or surgery
- 20 ml of autologous whole blood will be collected into tubes containing acid citrate dextrose and centrifuged at 1500 rpm for 10 minutes in order to get PRP at the top of the test tube. Then, the PRP will be further centrifuged at 3700 rpm for 10 minutes at room temperature of 22°C in order to obtain a platelet count 4.5 times higher than the base line. Platelet-poor plasma (PPP) will be partly removed and partly used to resuspend the platelets. Calcium gluconate will be added as an activator (1:9), i.e., 1 ml of calcium gluconate in 9 ml of PRP
Polydioxanone mono threads insertionProcedure or surgery
- Topical anesthetic cream will be applied for halfan hour on the involved area.
- polydioxanone mono threads (50 mm, 27 G) will be inserted at 1-cm spacing into the dermal layer of the skin; the threads will be arranged in a transverse and vertical line in the form of a mesh similar to cross-hatching technique.
- The total numbers will range from 8 to 10 each side. The skin of the face will be stretched by the non-dominant hand of the physician and the needle will be inserted by the other hand through the required point.
Fractional carbon dioxide laserDevice
- Topical anesthetic cream will be applied for 30 minutes before the procedure.
- BX300 device from AMI inc.,Korea will be used.
- Different settings will be used according to each individual case regarding the type of scar, severity and skin type fluence ranging from 36 to 42 j/cm2 will be used and pulse duration 1.8 ms.
- In an attempt to avoid common side effects that occur with fractional laser treatment, a lower fluence will be used in the first session and depending on the results, the fluence will be increased per treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Subcision plus platelet rich plasma | Active comparator | 3 sessions of scar subcision with platelet rich plasma injection at the same session with one month interval Receives: Procedure: Scar subcision; Procedure: Platelet rich plasma injection |
| Subcision plus Polydioxanone mono threads | Active comparator | 3 sessions of scar subcision followed by the insertion of Polydioxanone mono threads after the last session Receives: Procedure: Scar subcision; Procedure: Polydioxanone mono threads insertion |
| Subcision plus fractional carbon dioxide laser | Active comparator | 3 sessions of scar subcision with Fractional carbon dioxide laser at the same session with one month interval Receives: Procedure: Scar subcision; Device: Fractional carbon dioxide laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Management of severe atrophic acne scars
to assess the efficacy of the combination of subcision with Platelet rich plasma, Polydioxanone mono threads or fractional carbon dioxide laser in the treatment of severe atrophic acne scars (As per Goodman and Baron's acne qualitative scar grading scale)
Measured: 2 years
Secondary outcomes (1)
Comparing the 3 lines
to compare between the combination of subcision with Platelet rich plasma, Polydioxanone mono threads or fractional carbon dioxide laser in the treatment of severe atrophic acne scars regarding efficacy and safety.
(As per Goodman and Baron's acne qualitative scar grading scale)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Atrophic Acne ScarStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective controlled trial that will be conducted at Dermatology, venereology, and andrology Department, Al-Azhar university hospital, Assiut, in the period from December 2023 to December 2025, to assess the efficacy of combination of scar subcision with platelet rich plasma, polydioxanone mono threads or fractional carbon dioxide laserin the treatment of severe atrophic acne scars with 1:1:1 ratios and to compare between these modalities regarding safety and efficacy.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Omar Abdulrahman Hassan, Al-Azhar University
- Investigators
- Essam-Eldin M Mohamed, MD, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227481
- Sponsor's protocol ID
- Severe acne scars
- Status last verified
- Jan 2024
- First submitted
- 5 Nov 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alser OH, Goutos I. The evidence behind the use of platelet-rich plasma (PRP) in scar management: a literature review. Scars Burn Heal. 2018 Nov 18;4:2059513118808773. doi: 10.1177/2059513118808773. eCollection 2018 Jan-Dec.
PubMed 30479843Chawla S. Split Face Comparative Study of Microneedling with PRP Versus Microneedling with Vitamin C in Treating Atrophic Post Acne Scars. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):209-12. doi: 10.4103/0974-2077.150742.
PubMed 25722599Chilicka K, Rogowska AM, Szygula R. Effects of Topical Hydrogen Purification on Skin Parameters and Acne Vulgaris in Adult Women. Healthcare (Basel). 2021 Feb 1;9(2):144. doi: 10.3390/healthcare9020144.
PubMed 33535651Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x.
PubMed 17199653Mu YZ, Jiang L, Yang H. The efficacy of fractional ablative carbon dioxide laser combined with other therapies in acne scars. Dermatol Ther. 2019 Nov;32(6):e13084. doi: 10.1111/dth.13084. Epub 2019 Oct 7.
PubMed 31496020Oh IY, Kim BJ, Kim MN. Depressed Facial Scars Successfully Treated with Autologous Platelet-Rich Plasma and Light-Emitting Diode Phototherapy at 830 nm. Ann Dermatol. 2014 Jun;26(3):417-8. doi: 10.5021/ad.2014.26.3.417. Epub 2014 Jun 12. No abstract available.
PubMed 24966653Zhang DD, Zhao WY, Fang QQ, Wang ZC, Wang XF, Zhang MX, Hu YY, Zheng B, Tan WQ. The efficacy of fractional CO2 laser in acne scar treatment: A meta-analysis. Dermatol Ther. 2021 Jan;34(1):e14539. doi: 10.1111/dth.14539. Epub 2020 Nov 23.
PubMed 33190373Nilforoushzadeh MA, Lotfi E, Heidari-Kharaji M, Nickhah N, Alavi S, Mahmoudbeyk M. Comparing cannula-based subcision with the common needle method: A clinical trial. Skin Res Technol. 2020 Jan;26(1):39-44. doi: 10.1111/srt.12761. Epub 2019 Aug 1.
PubMed 31373077Tan J, Beissert S, Cook-Bolden F, Chavda R, Harper J, Hebert A, Lain E, Layton A, Rocha M, Weiss J, Dreno B. Evaluation of psychological well-being and social impact of atrophic acne scarring: A multinational, mixed-methods study. JAAD Int. 2021 Dec 23;6:43-50. doi: 10.1016/j.jdin.2021.11.006. eCollection 2022 Mar.
PubMed 35005652
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency Of Combination Of Scar Subcision With Platelet Rich Plasma, Polydioxanone Mono Threads Or Fractional Carbon Dioxide Laser In The Treatment Of Severe Atrophic Acne Scars: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06227481
- Acronym / sponsor ID
- Severe acne scars
- Conditions
- Atrophic Acne Scar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 29 Jan 2024 (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.
Many methods utilize for acne scar treatment including laser, cosmetic filler, microneedling, local tumescent, Subcision and chemical peels. These procedures can be used individually or as a combination therapy.
Combining procedures give better results. In our study we will try in the period from March 2024 to March 2026, to assess the efficacy of combination of scar subcision with platelet rich plasma, Polydioxanone mono threads or fractional Carbon dioxide laser in the treatment of severe atrophic acne scars with 1:1:1 ratios and to compare between these modalities regarding safety and efficacy.
Detailed description
This is a prospective controlled trial that will be conducted at Dermatology, venereology, and andrology Department, Al-Azhar university hospital, Assiut, in the period from March 2024 to March 2026, to assess the efficacy of combination of scar subcision with platelet rich plasma , polydioxanone mono threads or fractional carbon dioxide laser in the treatment of severe atrophic acne scars with 1:1:1 ratios and to compare between these modalities regarding safety and efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a prospective controlled trial that will be conducted at Dermatology, venereology, and andrology Department, Al-Azhar university hospital, Assiut, in the period from December 2023 to December 2025, to assess the efficacy of combination of scar subcision with platelet rich plasma, polydioxanone mono threads or fractional carbon dioxide laserin the treatment of severe atrophic acne scars with 1:1:1 ratios and to compare between these modalities regarding safety and efficacy.
| Arm | Type | Receives |
|---|---|---|
| Subcision plus platelet rich plasma | Active comparator | Procedure: Scar subcision, Procedure: Platelet rich plasma injection3 sessions of scar subcision with platelet rich plasma injection at the same session with one month interval |
| Subcision plus Polydioxanone mono threads | Active comparator | Procedure: Scar subcision, Procedure: Polydioxanone mono threads insertion3 sessions of scar subcision followed by the insertion of Polydioxanone mono threads after the last session |
| Subcision plus fractional carbon dioxide laser | Active comparator | Procedure: Scar subcision, Device: Fractional carbon dioxide laser3 sessions of scar subcision with Fractional carbon dioxide laser at the same session with one month interval |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with severe atrophic acne scars (as per Goodman and Baron's acne qualitative scar grading scale)
Key exclusion criteria (6 listed)
- Patients with active acne lesions.
- Patients having a keloid formation tendency.
- Patients with a history of bleeding disorder or severe anemia.
- Pregnant or lactating women.
- Patients received any treatment for scars in the last 6 months.
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 |
|---|---|---|
| Scar subcision* Subcision will be performed with18 gauge cannula at the margin of the scars on both sides of the face. * The cannula will be directed in a forward and backward motion producing a tunnel. Then, the it will be passed in sideways in a sweeping action to freeing up the scars from their bases. * Once finish, the pressure will be applied to reduce the bleeding and swelling. The topical antibiotic will be applied for 3 days. | Procedure or surgery | Subcision plus Polydioxanone mono threads, Subcision plus fractional carbon dioxide laser, Subcision plus platelet rich plasma |
| Platelet rich plasma injection• 20 ml of autologous whole blood will be collected into tubes containing acid citrate dextrose and centrifuged at 1500 rpm for 10 minutes in order to get PRP at the top of the test tube. Then, the PRP will be further centrifuged at 3700 rpm for 10 minutes at room temperature of 22°C in order to obtain a platelet count 4.5 times higher than the base line. Platelet-poor plasma (PPP) will be partly removed and partly used to resuspend the platelets. Calcium gluconate will be added as an activator (1:9), i.e., 1 ml of calcium gluconate in 9 ml of PRP | Procedure or surgery | Subcision plus platelet rich plasma |
| Polydioxanone mono threads insertion* Topical anesthetic cream will be applied for halfan hour on the involved area. * polydioxanone mono threads (50 mm, 27 G) will be inserted at 1-cm spacing into the dermal layer of the skin; the threads will be arranged in a transverse and vertical line in the form of a mesh similar to cross-hatching technique. * The total numbers will range from 8 to 10 each side. The skin of the face will be stretched by the non-dominant hand of the physician and the needle will be inserted by the other hand through the required point. | Procedure or surgery | Subcision plus Polydioxanone mono threads |
| Fractional carbon dioxide laser* Topical anesthetic cream will be applied for 30 minutes before the procedure. * BX300 device from AMI inc.,Korea will be used. * Different settings will be used according to each individual case regarding the type of scar, severity and skin type fluence ranging from 36 to 42 j/cm2 will be used and pulse duration 1.8 ms. * In an attempt to avoid common side effects that occur with fractional laser treatment, a lower fluence will be used in the first session and depending on the results, the fluence will be increased per treatment session. | Device | Subcision plus fractional carbon dioxide laser |
Primary outcome
Management of severe atrophic acne scars
Time frame: 2 years
to assess the efficacy of the combination of subcision with Platelet rich plasma, Polydioxanone mono threads or fractional carbon dioxide laser in the treatment of severe atrophic acne scars (As per Goodman and Baron's acne qualitative scar grading scale)
1 secondary outcome
Comparing the 3 lines
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Background: PubMed 30479843Alser OH, Goutos I. The evidence behind the use of platelet-rich plasma (PRP) in scar management: a literature review. Scars Burn Heal. 2018 Nov 18;4:2059513118808773. doi: 10.1177/2059513118808773. eCollection 2018 Jan-Dec.
- Background: PubMed 25722599Chawla S. Split Face Comparative Study of Microneedling with PRP Versus Microneedling with Vitamin C in Treating Atrophic Post Acne Scars. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):209-12. doi: 10.4103/0974-2077.150742.
- Background: PubMed 33535651Chilicka K, Rogowska AM, Szygula R. Effects of Topical Hydrogen Purification on Skin Parameters and Acne Vulgaris in Adult Women. Healthcare (Basel). 2021 Feb 1;9(2):144. doi: 10.3390/healthcare9020144.
- Background: PubMed 17199653Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x.
- Background: PubMed 31496020Mu YZ, Jiang L, Yang H. The efficacy of fractional ablative carbon dioxide laser combined with other therapies in acne scars. Dermatol Ther. 2019 Nov;32(6):e13084. doi: 10.1111/dth.13084. Epub 2019 Oct 7.
- Background: PubMed 24966653Oh IY, Kim BJ, Kim MN. Depressed Facial Scars Successfully Treated with Autologous Platelet-Rich Plasma and Light-Emitting Diode Phototherapy at 830 nm. Ann Dermatol. 2014 Jun;26(3):417-8. doi: 10.5021/ad.2014.26.3.417. Epub 2014 Jun 12. No abstract available.
- Background: PubMed 33190373Zhang DD, Zhao WY, Fang QQ, Wang ZC, Wang XF, Zhang MX, Hu YY, Zheng B, Tan WQ. The efficacy of fractional CO2 laser in acne scar treatment: A meta-analysis. Dermatol Ther. 2021 Jan;34(1):e14539. doi: 10.1111/dth.14539. Epub 2020 Nov 23.
- Background: PubMed 31373077Nilforoushzadeh MA, Lotfi E, Heidari-Kharaji M, Nickhah N, Alavi S, Mahmoudbeyk M. Comparing cannula-based subcision with the common needle method: A clinical trial. Skin Res Technol. 2020 Jan;26(1):39-44. doi: 10.1111/srt.12761. Epub 2019 Aug 1.
- Background: PubMed 35005652Tan J, Beissert S, Cook-Bolden F, Chavda R, Harper J, Hebert A, Lain E, Layton A, Rocha M, Weiss J, Dreno B. Evaluation of psychological well-being and social impact of atrophic acne scarring: A multinational, mixed-methods study. JAAD Int. 2021 Dec 23;6:43-50. doi: 10.1016/j.jdin.2021.11.006. eCollection 2022 Mar.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Essam-Eldin M Mohamed, MD study director
Al-Azhar University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Scar subcision, Platelet rich plasma injection and Polydioxanone mono threads insertion in people with Atrophic Acne Scar, run by Al-Azhar University.
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 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: status not confirmed, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed O Hassan (1155162310 ext. 0020, alproff2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Management of severe atrophic acne scars (time frame: 2 years). 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 NCT06227481, which also lists 9 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 Jan 2024.