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NCT Number: NCT06021275

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

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.

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Key information

Conditions

Scars Cicatrix Fibrosis Glucose Metabolism Disorders Hyperinsulinism Insulin Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University, Faculty of Medicine

Alexandria, Egypt

Location status: Recruiting

Location contact

Dalia I Halwag, PhD, MD

CONTACT

[email protected]

+0201224489473

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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 saline

Other

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

Primary outcomes

  1. Change in Scar

    Time frame: 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 )

Study contacts

Contact information is provided by the study sponsor or research team.

Dalia I Halwag, PhD, MD

CONTACT

[email protected]

+00201224489473

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 1, 2023
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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