Combined Procedures in the Treatment of Severe Acne Scars

Phase 2

Not yet recruiting

• Conditions: Atrophic Acne Scar
• Interventions: Procedure: Scar subcision; Procedure: Polydioxanone mono threads insertion; Procedure: Platelet rich plasma injection; Device: Fractional carbon dioxide laser

• Registration Number: NCT06227481
• Lead Sponsor: Al-Azhar University

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

Study Timeline

• Study First Submitted: 2023-11-05
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29
• Study Start: 2024-03-01
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subcision plus Polydioxanone mono threads	Scar subcision	3 sessions of scar subcision followed by the insertion of Polydioxanone mono threads after the last session
Subcision plus Polydioxanone mono threads	Polydioxanone mono threads insertion	3 sessions of scar subcision followed by the insertion of Polydioxanone mono threads after the last session
Subcision plus platelet rich plasma	Scar subcision	3 sessions of scar subcision with platelet rich plasma injection at the same session with one month interval
Subcision plus fractional carbon dioxide laser	Scar subcision	3 sessions of scar subcision with Fractional carbon dioxide laser at the same session with one month interval
Subcision plus platelet rich plasma	Platelet rich plasma injection	3 sessions of scar subcision with platelet rich plasma injection at the same session with one month interval
Subcision plus fractional carbon dioxide laser	Fractional carbon dioxide laser	3 sessions of scar subcision with Fractional carbon dioxide laser at the same session with one month interval

Primary Outcome Measures

Name	Time	Method
Management of severe atrophic acne scars	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)

Secondary Outcome Measures

Name	Time	Method
Comparing the 3 lines	2 years	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)