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

NCT ID: NCT06021275

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Scars Insulin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Microneedling with topical application of regular insulin

Group Type ACTIVE_COMPARATOR

Microneedling with topical application of regular insulin

Intervention Type OTHER

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

Microneedling only

Group Type ACTIVE_COMPARATOR

Microneedling with topical application of saline

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Dalia Ibrahim Halwag

Lecturer and Consultant of Dermatology, Venereology and Andrology, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alexandria University, Faculty of Medicine

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Dalia I Halwag, PhD, MD

Role: CONTACT

+00201224489473

Facility Contacts

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Dalia I Halwag, PhD, MD

Role: primary

+0201224489473

Other Identifiers

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Scar 1

Identifier Type: -

Identifier Source: org_study_id

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