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

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Cairo University (CU)

Status

Unknown

Conditions

Hypertrophic Scars

Treatments

Procedure: Intralesional Steroid Injection with and without Microneedling
Device: Fractional Microneedling Radiofrequency

Study type

Interventional

Funder types

Other

Identifiers

NCT04389619
Dermatology 13

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

Fractional Microneedling Radiofrequency
Experimental group
Description:
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.
Treatment:
Device: Fractional Microneedling Radiofrequency
Intralesional Steroid Injection with and without Microneedling
Active Comparator group
Description:
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.
Treatment:
Procedure: Intralesional Steroid Injection with and without Microneedling

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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