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Not yet recruiting NCT06770608

Various Procedural Treatment Options for Post-acne Atrophic Scars

Phase II Interventional Post-acne Atrophic Scars

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: micro-needling with topical human actrapid insulin, Micro-needling with topical Platelet rich plasma.
Who it may be relevant to
Registry conditions: Post-acne Atrophic Scars. Basic parameters: 13 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Outcome of Microneedling With Autologous Platelet Rich Plasma Verses Microneedling With Topical Insulin in the Treatment of Post-Acne Atrophic Scars

Overview

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

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.

Interventions

  • Procedure micro-needling with topical human actrapid insulin
    Micro-needling with topical application of 2ml of human actrapid insulin once monthly for 4 months
  • Procedure Micro-needling with topical Platelet rich plasma
    Micro-needling with topical application of 2ml Platelet rich plasma once monthly for 4 months

Primary outcome measures

  • To compare the outcome of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars [Time frame: Clinical assessment for efficacy will be done monthly for 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Sheikh zayed Medical College and Hospital — Rahim Yar Khan

Identifiers

NCT: NCT06770608 · sheikh-ZMC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗