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

Primary Purpose

Hypertrophic Scars

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fractional Microneedling Radiofrequency
Intralesional Steroid Injection with and without Microneedling
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Scars

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Maha Fathy Elmasry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fractional Microneedling Radiofrequency

Intralesional Steroid Injection with and without Microneedling

Arm 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.

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.

Outcomes

Primary Outcome Measures

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
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.
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

Secondary Outcome Measures

Full Information

First Posted
May 12, 2020
Last Updated
May 12, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04389619
Brief Title
Fractional Microneedling RF vs Intralesional Steroid With & Without Microneedling in Hypertrophic Scars
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scars

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fractional Microneedling Radiofrequency
Arm Type
Experimental
Arm 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.
Arm Title
Intralesional Steroid Injection with and without Microneedling
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Fractional Microneedling Radiofrequency
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intralesional Steroid Injection with and without Microneedling
Intervention 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. 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.
Primary Outcome Measure Information:
Title
Calculation of patient and observer scar assessment scale (POSAS) to assess change of hyertrophic scars
Description
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
Time Frame
6 months
Title
Photographic documentation will be performed to assess change of hypertrophic scar(s)
Description
Photographic documentation will be performed by obtaining digital photographs for hypertrophic scar(s) before every session and one month after the last session.
Time Frame
6 months
Title
Measurement of tissue levels of both platelet derived growth factor (PDGF) & connective tissue growth factor (CTGF) to assess change of hypertrophic scars
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Maha Fathy Elmasry
City
Cairo
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

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

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