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Clinical Trials/NCT04389619
NCT04389619UnknownNot Applicable

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.

Cairo University2 sites in 1 country30 target enrollmentStarted: May 10, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
2
Primary Endpoint
Calculation of patient and observer scar assessment scale (POSAS) to assess change of hyertrophic scars

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Calculation of patient and observer scar assessment scale (POSAS) to assess change of hyertrophic scars

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maha Fathy Elmasry

principal investigator

Cairo University

Study Sites (2)

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