NCT06978361

Brief Summary

This study compares the outcome of two procedures for the treatment of atrophic acne scars.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 18, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

May 10, 2025

Last Update Submit

May 16, 2025

Conditions

Keywords

Post-acne atrophic scarsMicroneedling with autologous Platelet- Rich PlasmaMicroneedling with topical insulin

Outcome Measures

Primary Outcomes (1)

  • Efficacy of treatment

    Efficacy will be determined by using the Goodman and Baron's Scarring Grading System as" Percentage of decrease in acne scar grade" i.e calculated through subtracting post treatment grade from pre treatment grade and then multiplying it with 100 in both treatment groups .

    6 months

Study Arms (2)

Group A , Microneedling with autologous PRP

EXPERIMENTAL

Patients in group A will undergo microneedling with autologous PRP i.e cleansing of the treatment area with an antiseptic solution will be performed.Topical anesthetic will be applied to the area for 20-30 mins .Approximately 10ml of blood will be drawn into sterile tubes. blood sample will be placed in centrifuge 10-15mins which separates the blood components, allowing for the collection of PRP .Then sterile microneedling device will be used to begin the procedure by adjusting the needle depth according to scar severity.Controlled microinjuries to the skin will be made by moving the device in a systematic pattern over the treatment area .After microneedling ,immediately harvested PRP will be applied to the treated area ,allowing it to penetrate into the microinjuries .Patient will be asked for consideration of aftercare instructions ,including avoiding sun exposure , harsh skincare products and strenuous exercise for few days.

Procedure: Microneedling with autologous Platelet Rich Plasma

Group B , Microneedling with Topical insulin

EXPERIMENTAL

Patients in group B will undergo microneedling with Topical insulin i.e cleansing of the treatment area with an antiseptic solution will be performed.Topical anesthetic will be applied to the area for 20-30 mins to reduce discomfort during the procedure.Then sterile microneedling device will be used to begin the procedure by adjusting the needle depth according to scar severity.Controlled microinjuries to the skin will be made by moving the device in a systematic pattern over the treatment area .After microneedling Insulin (Regular) will be applied immediately to the treated area. insulin will be allowed to penetrate into the microinjuries created by the microneedling for about 30 mins . Patient will be asked for consideration of aftercare instructions ,including avoiding sun exposure , harsh skincare products and strenuous exercise for few days.

Procedure: Microneedling with topical insulin

Interventions

Patients in group A will undergo Microneedling with autologous PRP

Group A , Microneedling with autologous PRP

Patients in group B will undergo Microneedling with Topical insulin ( regular).

Group B , Microneedling with Topical insulin

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients confirmed with post-acne atrophic scars . No prior treatment for scars in last 6 months.

You may not qualify if:

  • Patient with active acne or other skin conditions (e.g eczema , psoriasis). Patients on oral or topical retinoids. Pregnant or lactating Mothers. Patients with recurrent herpes simplex infection. Previous Hx of keloids / hypertrophic scarring. Deranged blood glucose levels. Bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber Teaching Hospital

Peshawar, KPK ,Pakistan, 25000, Pakistan

RECRUITING

MeSH Terms

Interventions

Percutaneous Collagen InductionInsulin

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPuncturesRehabilitationProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Soaiba Naeem, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 10, 2025

First Posted

May 18, 2025

Study Start

March 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Patient's confidentiality may be breached .

Locations