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

Primary Purpose

Scars, Insulin

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Microneedling with topical application of regular insulin
Microneedling with topical application of saline
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scars focused on measuring Insulin, scars

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alexandria University, Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Microneedling with topical application of regular insulin

Microneedling only

Arm Description

Outcomes

Primary Outcome Measures

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 )

Secondary Outcome Measures

Full Information

First Posted
August 27, 2023
Last Updated
September 7, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT06021275
Brief Title
Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars
Official Title
Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scars, Insulin
Keywords
Insulin, scars

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microneedling with topical application of regular insulin
Arm Type
Active Comparator
Arm Title
Microneedling only
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Microneedling with topical application of regular insulin
Intervention Description
Microneeling preformed onto the scar In one group insulin will be applied while saline will be used in the second group
Intervention Type
Other
Intervention Name(s)
Microneedling with topical application of saline
Intervention Description
Microneeling preformed onto the scar In one group insulin will be applied while saline will be used in the second group
Primary Outcome Measure Information:
Title
Change in Scar
Description
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 )
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dalia I Halwag, PhD, MD
Phone
+00201224489473
Email
daliahalwag@gmail.com
Facility Information:
Facility Name
Alexandria University, Faculty of Medicine
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalia I Halwag, PhD, MD
Phone
+0201224489473
Email
daliahalwag@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study protocol after finishing all the research and publishing the research

Learn more about this trial

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

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