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

May 12, 2020 updated by: Maha Fathy Elmasry, Cairo University

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.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Maha Fathy Elmasry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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.
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dermatology 13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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