Combined Procedures in the Treatment of Severe Acne Scars

Atrophic Acne Scar Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06227481
• Other study ID #: Severe acne scars
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: January 2024
• Source: Al-Azhar University
• Contact: Ahmed O Hassan
• Phone: 1155162310
• Email: alproff2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: March 31, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Atrophic Acne Scar
• Atrophy

Intervention

Procedure:
• 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.
• 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
• 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.

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

References & Publications (9)

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. — View 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. Erratum In: J Cutan Aesthet Surg. 2015 Jan-Mar;8(1):75. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 years
Secondary	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)	2 years