Microneedling Therapy With or Without Amnion Bilayer Sheeting on Scar Tissue

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Scars, Hypertrophic Burn Scar

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

In this study, one scar in one subject, will be divided into two areas, one-half of the scar will receive an intervention of microneedling, and the other half will receive microneedling+amnion bilayer. Hence, one subject will receive both interventions at the same time

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Microoneedling and Amnion Bilayer

Intervention Type PROCEDURE

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.

Microneedling

Microneedling is a dermaroller procedure that uses small needles to prick the skin.

Group Type PLACEBO_COMPARATOR

Microoneedling

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Dr.dr.Irma Bernadette, SpKK (K)

Irma Bernadette S. Sitohang, MD, PhD - Head of Cosmetic Dermatology Division, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Responsibility Role SPONSOR_INVESTIGATOR