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

NCT04389619 | Unknown

• 1 other identifier: Dermatology 13
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertrophic Scars

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Fractional Microneedling Radiofrequency

EXPERIMENTAL

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.

Device: Fractional Microneedling Radiofrequency

Intralesional Steroid Injection with and without Microneedling

ACTIVE COMPARATOR

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.

Procedure: Intralesional Steroid Injection with and without Microneedling

Interventions

Fractional Microneedling Radiofrequency DEVICE

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.

Fractional Microneedling Radiofrequency

Intralesional Steroid Injection with and without Microneedling PROCEDURE

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.

Intralesional Steroid Injection with and without Microneedling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Maha Fathy Elmasry

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 15, 2020
• Study Start: May 10, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Locations

EG (1)