Various Procedural Treatment Options for Post-acne Atrophic Scars

NCT06770608 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: sheikh-ZMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-acne Atrophic Scars

Keywords

Microneedling; Autologous platelet rich plasma; Topical insulin; Post-acne atrophic scars

Outcome Measures

Primary Outcomes (1)

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

  Efficacy will be assesssed clinically at each follow up visit. Final efficacy of each treatment will be determined at last follow up visit( i.e. at 6th month after start of treatment).The final efficacy will be divided into following groups on the basis of clinical resolution of disease: 1.Remission: It is defined as complete resolution of all scar leaving behind normal skin. 2.Improvement: It is defined as a more than 50% healing of scars ,as clinically measured by the surface area from the baseline. 3.No improvement: It is defined as less than a 50% improvement in the healing of scars, as measured clinically by the surface area from the baseline.

  Clinical assessment for efficacy will be done monthly for 6 months

Study Arms (2)

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

ACTIVE COMPARATOR

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

Procedure: micro-needling with topical human actrapid insulin

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

ACTIVE COMPARATOR

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

Procedure: Micro-needling with topical Platelet rich plasma

Interventions

micro-needling with topical human actrapid insulin PROCEDURE

Micro-needling with topical application of 2ml of human actrapid insulin once monthly for 4 months

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

Micro-needling with topical Platelet rich plasma PROCEDURE

Micro-needling with topical application of 2ml Platelet rich plasma once monthly for 4 months

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

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

Study Sites (1)

Sheikh zayed Medical College and Hospital

Rahim Yar Khan, Punjab Province, 644200, Pakistan

Location

Central Study Contacts

Mohibullah, Post graduate resident

CONTACT

+923168716717; mohibzahidi.123@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident in Dermatology

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 13, 2025
• Study Start: January 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)