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

• Sponsor: Alexandria University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06021275
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scars; Insulin	Other: Microneedling with topical application of regular insulin; Other: Microneedling with topical application of saline	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Microneedling with topical application of regular insulin	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
Active Comparator: Microneedling only	Other: 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

Outcome Measures

Primary Outcome Measures

1. 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 )

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria University, Faculty of Medicine	Alexandria		Egypt

Sponsors and Collaborators

• Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dalia Ibrahim Halwag, Lecturer and Consultant of Dermatology, Venereology and Andrology, Faculty of Medicine, Alexandria University
• ClinicalTrials.gov Identifier: NCT06021275
• Other Study ID Numbers: Scar 1
• First Posted: Sep 1, 2023
• Last Update Posted: Sep 11, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dalia Ibrahim Halwag, Lecturer and Consultant of Dermatology, Venereology and Andrology, Faculty of Medicine, Alexandria University: Insulin; scars
• Additional relevant MeSH terms: Cicatrix; Atrophy; Insulin; Insulin, Globin Zinc

Study Results

No Results Posted as of Sep 11, 2023