Microneedling Therapy With or Without Amnion Bilayer Sheeting on Scar Tissue

NCT04995302 | Unknown

• 1 other identifier: MicroneedlingScar
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scars, Hypertrophic; Burn Scar

Keywords

Microneedling; Amnion bilayer; Scar

Outcome Measures

Primary Outcomes (7)

• Change in Subjective Pain in one month

  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

  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

  Qualitative description of blood vessel structure, pigmentation density and erythema

  Baseline, day 7 , day 30

• Change in Biopsy Evaluation in one month

  Descriptive evaluation using HE staining

  Baseline, Day 7 and day 30

• Change in Skin Thickness in one month

  Evaluation with USG of epidermal and dermal layer (in pixels)

  Baseline, Day 7 and day 30

• Change in Subjective Improvement in one month

  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

  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

Study Arms (2)

Microneedling and Amnion Bilayer

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

Procedure: Microoneedling

Interventions

Microoneedling and Amnion Bilayer 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 and Amnion Bilayer

Microoneedling 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.

Microneedling

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dr.dr.Irma Bernadette, SpKK (K): lead

Study Sites (1)

dr. Cipto Mangunkusumo Hospital

Jakarta, Jakarta Pusat, 10430, Indonesia

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic; Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Irma B Sitohang

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irma B Sitohang

CONTACT

+62818130761; irma_bernadette@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: 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

Model Details: 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

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 6, 2021
• Study Start: September 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: January 31, 2022
• Last Updated: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)