Fractional Microneedling RF vs Intralesional Steroid With & Without Microneedling in Hypertrophic Scars

Not Applicable

• Conditions: Hypertrophic Scars
• Interventions: Device: Fractional Microneedling Radiofrequency; Procedure: Intralesional Steroid Injection with and without Microneedling

• Registration Number: NCT04389619
• Lead Sponsor: Cairo University

Brief Summary

Comparing between the effect of Fractional Microneedling Radiofrequency Versus Intralesional Steroid Injection with and without Microneedling on Tissue levels of PDGF \& CTGF in Hypertrophic Scars

Detailed Description

In each patient, each one of the two scars, or each side of a large scar will be assigned to one of the following treatment methods: 1-Fractional microneedling radiofrequency 2-Intralesional steroids injection. Scars treated with intralesional steroids will be subgrouped into two groups, one group treated with only intralesional steroids and the other group treated with intralesional steroids and followed by microneedling. Fractional microneedling radiofrequency parameters; Power: 6 v, Exposure time: 800 ms. Depth: 2.5 mm (using non-insulated micro-needles), Frequency: 2 Hz. For intralesional steroids injection, Triamcinolone acetonide will be injected in concentration 1:2 (20 mg/dl) using insulin syringe. Microneedling will be done using the same tip of the fractional microneedling radiofrequency at same depth. All patients will receive 5 treatment sessions 4 weeks apart.

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-10
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-12
• Study First Posted: 2020-05-15
• Last Update Posted: 2020-05-15
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with mature hypertrophic scars.
• Patients with age above 18 years.
• Both males and females.
• Patients with two separate lesions, each 3 cm length at least OR a large sized lesion 10 cm length at least.

Exclusion Criteria

• Patients with unrealistic expectations.
• Patients with active skin infections or autoimmune diseases.
• Non-compliant patients.
• Patients who had received any form of treatment for scars during the last six months.
• Recent use of isotretinoin within six months prior to the procedures.
• Patient with known allergy to lidocaine.
• Pregnancy & Lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fractional Microneedling Radiofrequency	Fractional Microneedling Radiofrequency	In every patient, each one of the two scars, or each side of a large scar will be assigned to fractional microneedling radiofrequency parameters; Power: 6 v, Exposure time: 800 ms. Depth: 2.5 mm (using non-insulated micro-needles), Frequency: 2 Hz for 5 treatment sessions 4 weeks apart.
Intralesional Steroid Injection with and without Microneedling	Intralesional Steroid Injection with and without Microneedling	In every patient, each one of the two scars, or the other side of a large scar will be assigned to intralesional steroids injection, Triamcinolone acetonide will be injected in concentration 1:2 (20 mg/dl) using insulin syringe. Microneedling will be done using the same tip of the fractional microneedling radiofrequency at same depth. Patients will receive 5 treatment sessions 4 weeks apart.

Primary Outcome Measures

Name	Time	Method
Calculation of patient and observer scar assessment scale (POSAS) to assess change of hyertrophic scars	6 months	Calculation of patient and observer scar assessment scale (POSAS) before every session and one month after the last session to clinically assess change of hyertrophic scars
Photographic documentation will be performed to assess change of hypertrophic scar(s)	6 months	Photographic documentation will be performed by obtaining digital photographs for hypertrophic scar(s) before every session and one month after the last session.
Measurement of tissue levels of both platelet derived growth factor (PDGF) & connective tissue growth factor (CTGF) to assess change of hypertrophic scars	6 months	Measurement of tissue levels of both PDGF \& CTGF to assess change of hypertrophic scars. Tissue levels of both PDGF \& CTGF will be measured by PCR in biopsies obtained from the scar areas before the treatment sessions and one month after the last session

Trial Locations

Locations (1)

Maha Fathy Elmasry; 🇪🇬 Cairo, Egypt