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

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ClinicalTrials.gov Identifier: NCT06021275
Recruitment Status : Recruiting
First Posted : September 1, 2023
Last Update Posted : February 2, 2024
Sponsor:
Information provided by (Responsible Party):
Dalia Ibrahim Halwag, Alexandria University

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : October 1, 2023
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arms and Interventions
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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
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Primary Outcome Measures :
  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 )


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06021275


Contacts
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Contact: Dalia I Halwag, PhD, MD +00201224489473 daliahalwag@gmail.com

Locations
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Egypt
Alexandria University, Faculty of Medicine Recruiting
Alexandria, Egypt
Contact: Dalia I Halwag, PhD, MD    +0201224489473    daliahalwag@gmail.com   
Sponsors and Collaborators
Alexandria University
More Information
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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: September 1, 2023    Key Record Dates
Last Update Posted: February 2, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study protocol after finishing all the research and publishing the research

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dalia Ibrahim Halwag, Alexandria University:
Insulin
scars
Additional relevant MeSH terms:
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Cicatrix
Atrophy
Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical
 Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs