Various Procedural Treatment Options for Post-acne Atrophic Scars

Sheikh Zayed Medical College

Status and phase: Not yet enrolling; Phase 2

Conditions: Post-acne Atrophic Scars

Treatments: Procedure: Micro-needling with topical Platelet rich plasma; Procedure: micro-needling with topical human actrapid insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT06770608

sheikh-ZMC

Details and patient eligibility

About

Post acne scars are formed as a result of very inflamed and nodulocystic acne. Most common type of acne scars are atrophic scars and they are further classified on the basis of depth and size of destruction into ice pick, boxcar and rolling scars. Evaulating the most efficacious, safe and affordable treatment option is the need of the hour. This study is going to compare the efficacy of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars as to find out the relatively more effective and safer treatment.

Full description

Acne vulgaris is a disease involving inflammation or blockage of pilosebaceous units. Post acne scars are formed as a result of very inflamed and nodulocystic acne. There are many procedures to treat post-acne scar including lasers, platelet rich plasma, fillers, chemical peeling, pulsed dye lasers, fractional CO2 lasers, subcision and punch techniques, but almost lead to additional scaring and pigmentation.The major purpose of our study is comparison of outcome of micro-needling and platelet rich plasma as opposed to combining it with topical in atrophic scars due to acne, as topical insulin is natural component of body, cheap, easy to use, minimally invasive and a new therapy for post-acne scars. No local study was found in literature research. Hence, any effect of this potentially very effective therapeutic modality needs to be investigated.

OBJECTIVE: "To compare the outcome of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars".

Material & Methods: This randomized comarative study will be carried out in Outpatient Dermatology Department, Sheikh Zayed Hospital Rahim Yar Khan, Pakistan. Approval of the study has been taken from ethical review committee of the hospital.Data will be collected on prescribed form. Patient will be selected on basis of inclusion & exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will includes 60 patients which will be divided into 2 groups A & B, 30 in each group. Group A will receive micro-needling with topical application of 2ml of human actrapid insulin. Group B will receive micro-needling with topical application of 2ml Platelet rich plasma. Face of the patient will be washed after 30 mints and patients will be strictly instructed regarding sun protection at least 1 day after the procedure. Blood glucose level will be checked prior to and 30 mints following procedure.

At monthly interval for total 4 sessions and follow up visit will be after 2 months of last session.Data will be analyzed by SPSS v25.0.

Chi-square test will be applied for qualitative variables and t-test will be used for quantitative variables.

Enrollment: 60 estimated patients

Sex: All

Ages: 13 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 13-50 years
• Gender: both male and female
• Type of acne scar: Atrophic acne scar
• Patients not taking prior treatment in last 1-2 months

Exclusion criteria

• Pregnancy and lactating females
• Bleeding disorders
• Platelet count less than 100000
• Hypersensitivity to insulin, PRP
• Keloidal tendency
• Active herpes simples, warts and molluscum contagiosum
• Unrealistic expectations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Micro-needling with topical human actrapid insulin group (Group A)

Active Comparator group

Description:

Patients with post-acne atrophic scars will receive micro-needling with topical application of 2ml of human actrapid insulin

Treatment:

Procedure: micro-needling with topical human actrapid insulin

Micro-needling with topical Platelet rich plasma(Group B)

Active Comparator group

Description:

Patients with post-acne atrophic scars will receive micro-needling with topical application of 2ml Platelet rich plasma

Treatment:

Procedure: Micro-needling with topical Platelet rich plasma