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NCT06021275 Clinical Trial

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

Scars Clinical Trial

Official title:
Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06021275
Other study ID # Scar 1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date May 2024

Study information
Verified date January 2024
Source Alexandria University
Contact Dalia I Halwag, PhD, MD
Phone +00201224489473
Email daliahalwag@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Microneedling with topical application of regular insulin
Microneeling preformed onto the scar In one group insulin will be applied while saline will be used in the second group
• Microneedling with topical application of saline
Microneeling preformed onto the scar In one group insulin will be applied while saline will be used in the second group

Locations
Country Name City State
Egypt Alexandria University, Faculty of Medicine Alexandria

Sponsors (1)
Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Scar 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 ) 4 months
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