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

Hypertrophic Scars Clinical Trial

Official title:

Effect of Fractional Microneedling Radiofrequency Versus Intralesional Steroid Injection With and Without Microneedling on Tissue Levels of PDGF & CTGF in Hypertrophic Scars: a Randomized Comparative Clinical Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04389619
• Other study ID #: Dermatology 13
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 10, 2020
• Est. completion date: December 2020

Study information

• Verified date: May 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scars
• Hypertrophy

Intervention

Device:
• 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. 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.

Procedure:
• 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. o 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. 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.

Locations

Country	Name	City	State
Egypt	Maha Fathy Elmasry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculation of patient and observer scar assessment scale (POSAS) to assess change of hyertrophic scars	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	6 months
Primary	Photographic documentation will be performed to assess change of hypertrophic scar(s)	Photographic documentation will be performed by obtaining digital photographs for hypertrophic scar(s) before every session and one month after the last session.	6 months
Primary	Measurement of tissue levels of both platelet derived growth factor (PDGF) & connective tissue growth factor (CTGF) to assess change of hypertrophic scars	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	6 months