Microneedling Therapy With or Without Amnion Bilayer Sheeting on Scar Tissue

July 31, 2021 updated by: Dr.dr.Irma Bernadette, SpKK (K)

The Comparison of Microneedling Therapy With or Without Amnion Bilayer Sheeting on Post-Burn Hypertrophic Scar Tissue

The aim of this study is to compare the outcome of microneedling therapy with or without amnion bilayer sheeting on post-burn hypertrophic scar tissue. A clinical trial will be conducted with 17 samples, from September to December 2021.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

High degree burn injuries commonly result in abnormal scar formation, and therapy for this hypertrophic scar remains a challenge. For years, microoneedling has been used for treating hypertrophic scars, and an addition of amnion bilayer sheeting is expected to provide a more favorable outcome. This study aims to compare microneedling therapy with or without amnion bilayer sheeting on post-burn hypertrophic scars tissue. This is an interventional study with 17 samples, aged 18-50 years old. Therapeutic outcomes will be evaluated using visual analog scale, degree of erythema, patient's subjective evaluation, dermoscope, biopsy, and skin ultrasound.

Study Type

Interventional

Enrollment (Anticipated)

17

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 Contact

Study Locations

  • Indonesia
    • Jakarta Pusat
      • Jakarta, Jakarta Pusat, Indonesia, 10430
        • Dr. Cipto Mangunkusumo Hospital
        • Contact:

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients, aged 18-50 years old
  • Patients with post-burn, mature hypertrophic scars, localized in any areas other than the face, with a minimum of 5 cm in diameter.
  • Patients are willing to participate in the study and sign an informed consent form

Exclusion Criteria:

  • Patients with scars less than 5 cm in diameter
  • Patients with scars localized solely in the face
  • Hypertrophic scars with keloid
  • Patients with comorbidities

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Microneedling and Amnion Bilayer
Microneedling is a dermaroller procedure that uses small needles to prick the skin. Amnion bilayer is used as an additional therapy after microneedling therapy.
Procedure: Microoneedling and Amnion Bilayer
Microneedling is conducted following a three-week application of tretinoin cream. Then, scar tissue that has been treated with microneedling is covered with amnion bilayer for 72 hours.
Placebo Comparator: Microneedling
Microneedling is a dermaroller procedure that uses small needles to prick the skin.
Procedure: Microoneedling
Microneedling is conducted following a three-week application of tretinoin cream. Then, scar tissue that has been treated with microneedling is covered with an antibacterial gauze dressing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Subjective Pain in one month
Time Frame: Baseline, day 7, day 30
Using Visual Analog Scale (0-10, 0 indicates no pain and 10 indicates severe pain)
Baseline, day 7, day 30
Change in Erythema Degree in one month
Time Frame: Baseline, day 7, day 30
Using Erythema score (0-4, 0 indicates no erythema and 4 indicates severe erythema)
Baseline, day 7, day 30
Change in Dermoscopy Evaluation in one month
Time Frame: Baseline, day 7 , day 30
Qualitative description of blood vessel structure, pigmentation density and erythema
Baseline, day 7 , day 30
Change in Biopsy Evaluation in one month
Time Frame: Baseline, Day 7 and day 30
Descriptive evaluation using HE staining
Baseline, Day 7 and day 30
Change in Skin Thickness in one month
Time Frame: Baseline, Day 7 and day 30
Evaluation with USG of epidermal and dermal layer (in pixels)
Baseline, Day 7 and day 30
Change in Subjective Improvement in one month
Time Frame: Baseline , Day 7 and day 30
Using Patient and Observer Scar Assessment Scale (Patients scored from 1-10 in pain, itch, color, stiffness, thickness and irregularity of their scar, observer gives score on vascularity, pigmentation, thickness, relief, pliability, and surface area)
Baseline , Day 7 and day 30
Change in Subjective Improvement in one month
Time Frame: Baseline , Day 7 and day 30
Using Modified Vancouver Scar Scale (Evaluating pigmentation (score 0-3), vascularity (0-3), pliability (0-5), height (0-5))
Baseline , Day 7 and day 30

Collaborators and Investigators

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

Sponsor

Dr.dr.Irma Bernadette, SpKK (K)

Investigators

  • Principal Investigator: Irma B Sitohang, Fakultas Kedokteran Universitas Indonesia

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 (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

July 31, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

July 31, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MicroneedlingScar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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