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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04995302
Other study ID # MicroneedlingScar
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date January 31, 2022

Study information

Verified date July 2021
Source Indonesia University
Contact Irma B Sitohang
Phone +62818130761
Email irma_bernadette@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 17
Est. completion date January 31, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
Indonesia dr. Cipto Mangunkusumo Hospital Jakarta Jakarta Pusat

Sponsors (1)

Lead Sponsor Collaborator
Dr.dr.Irma Bernadette, SpKK (K)

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Change in Dermoscopy Evaluation in one month Qualitative description of blood vessel structure, pigmentation density and erythema Baseline, day 7 , day 30
Primary Change in Biopsy Evaluation in one month Descriptive evaluation using HE staining Baseline, Day 7 and day 30
Primary Change in Skin Thickness in one month Evaluation with USG of epidermal and dermal layer (in pixels) Baseline, Day 7 and day 30
Primary 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
Primary 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
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