Various Procedural Treatment Options for Post-acne Atrophic Scars

NCT ID: NCT06770608

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post-acne Atrophic Scars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

micro-needling with topical human actrapid insulin

Intervention Type PROCEDURE

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

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

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

Group Type ACTIVE_COMPARATOR

Micro-needling with topical Platelet rich plasma

Intervention Type PROCEDURE

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

Interventions

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micro-needling with topical human actrapid insulin

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

Intervention Type PROCEDURE

Micro-needling with topical Platelet rich plasma

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheikh Zayed Medical College

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mohibullah Zahidi

Post Graduate Resident in Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheikh zayed Medical College and Hospital

Rahim Yar Khan, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Mohibullah, Post graduate resident

Role: CONTACT

+923168716717

Facility Contacts

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Sheikh zayed Medical college SZMC/H

Role: primary

+92689230168

Other Identifiers

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sheikh-ZMC

Identifier Type: -

Identifier Source: org_study_id

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