Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars

Not Applicable

Recruiting

• Conditions: Scars; Insulin
• Interventions: Other: Microneedling with topical application of saline; Other: Microneedling with topical application of regular insulin

• Registration Number: NCT06021275
• Lead Sponsor: Alexandria University

Brief Summary

Recently, few studies have attempted to test the regenerative effects of human insulin application by microneedling on atrophic scars versus other topical preparations. However, the scars were limited etiologically to acne scars. In addition, a lack of inclusion of a control group instead of comparing topical preparations with insulin was also a limitation to these studies. A control group consisting of microneedling alone would have served as a better comparison in order to determine whether the effects of microneedling are augmented by topical protein-rich preparations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-27
• Study First Submitted QC: 2023-08-27
• Study First Posted: 2023-09-01
• Study Start: 2023-10-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-27
• Last Update Posted: 2024-07-30
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients aged 12 to 60 years
2. Atrophic scars (traumatic or surgical)
3. Completely healed scars

Exclusion Criteria

1. Patients with a tendency or history of hypertrophic or keloidal scars
2. Patients who received treatment for their scar in the past 3 months
3. Diabetic patients or those with a history of Dysglycemia
4. Pregnant, or lactating females
5. Patients with active infection at the site of scar
6. Patients currently receiving isotretinoin treatment or in the past month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microneedling only	Microneedling with topical application of saline	-
Microneedling with topical application of regular insulin	Microneedling with topical application of regular insulin	-

Primary Outcome Measures

Name	Time	Method
Change in Scar	4 months	According the different scar assessment scores (e.g.POSAS score - The Patient and Observer Scar Assessment Scale score, range from 6 to 60, the higher the score the worse the scar, lowering in the score denotes improvement )

Trial Locations

Locations (1)

Alexandria University, Faculty of Medicine; 🇪🇬 Alexandria, Egypt