NCT06227481

Combined Procedures in the Treatment of Severe Acne Scars

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atrophic Acne Scar

Interventions

Type	Name	Description
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.
PROCEDURE	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	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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-03-01
• Completion: 2026-03-31
• First posted: 2024-01-29
• Last updated: 2024-01-29