Clinical trial NCT06227481: Combined Procedures in the Treatment of Severe Acne Scars
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Atrophic Acne Scar
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

• Patients with severe atrophic acne scars (as per Goodman and Baron's acne qualitative scar grading scale)

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Management of severe atrophic acne scars
timeFrame: 2 years
Secondary outcomes:
measure: Comparing the 3 lines
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Al-Azhar University
name: Essam-Eldin M Mohamed, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Chawla 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.
citation: Chilicka 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.
citation: Goodman 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.
citation: Mu 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.
citation: Oh 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.
citation: Zhang 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.
citation: Nilforoushzadeh 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.
citation: Tan 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.