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

NCT06021275 | Recruiting

• 1 other identifier: Scar 1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Scars; Insulin

Keywords

Insulin; scars

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Microneedling with topical application of regular insulin

ACTIVE COMPARATOR

Other: Microneedling with topical application of regular insulin

Microneedling only

ACTIVE COMPARATOR

Other: Microneedling with topical application of saline

Interventions

Microneedling with topical application of regular insulin OTHER

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 regular insulin

Microneedling with topical application of saline OTHER

Microneeling preformed onto the scar In one group insulin will be applied while saline will be used in the second group

Microneedling only

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 12 to 60 years
• Atrophic scars (traumatic or surgical)
• Completely healed scars

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University, Faculty of Medicine

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Cicatrix; Insulin Resistance

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Central Study Contacts

Dalia I Halwag, PhD, MD

CONTACT

+00201224489473; daliahalwag@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer and Consultant of Dermatology, Venereology and Andrology, Faculty of Medicine

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 1, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)