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
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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 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 |
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 |
- 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 )
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Ages Eligible for Study: | 12 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
Contact: Dalia I Halwag, PhD, MD | +00201224489473 | daliahalwag@gmail.com |
Egypt | |
Alexandria University, Faculty of Medicine | Recruiting |
Alexandria, Egypt | |
Contact: Dalia I Halwag, PhD, MD +0201224489473 daliahalwag@gmail.com |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Insulin scars |
Cicatrix Atrophy Fibrosis Pathologic Processes Pathological Conditions, Anatomical |
Insulin Insulin, Globin Zinc Hypoglycemic Agents Physiological Effects of Drugs |