Efficacy of triamcinolone acetonide dissolving microneedle patch for the treatment of hypertrophic scar and keloid: A randomized, double-blinded, placebo-controlled split-scar study

Phase 2

• Conditions: Triamcinolone acetonide dissolving microneedle patch for hypertrophic scar or keloid; triamcinolone acetonide, dissolving microneedle patch, hypertrophic scar, keloid

• Registration Number: TCTR20220318004
• Lead Sponsor: Division of Dermatology, Department of internal medicine, Faculty of medicine, Thammasat University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-18
• Study Completion: 2022-03-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Healthy male or female participants, aged 18-60.
2. Participants had hypertrophic scar or keloid more than 2 cm without any previous treatments, more than 6 months of intralesional steroids, or more than 3 months of light & laser treament.
3. Participants who are willing to join the project after receiving a detailed description of the project and signing a consent form for the study.
4. Participants can follow the testing method to follow up on treatment results throughout the study period and can report side effects that arise from the study immediately

Exclusion Criteria

1. Participants who had history of treatment with intralesional steroids less than 6 months or light & laser treatment less than 3 months.
2. Participants who had a history of using systemic corticosteroids (oral, intramuscular, intravenous), chemotherapy, warfarin, heparin, or systemic retinoids
3. Participants who had active dermatitis or skin infection at the study site
4. Participants who are pregnant, breastfeeding or planning to become pregnant.
5. Participants who had a history of liver diseases, renal diseases.
6. Participants with any type of diabetes mellitus.
7.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scar volume at day 0, 14-16, 28-30, 60 days skin imaging analysis ( Visioscan)

Secondary Outcome Measures

Name	Time	Method
appearance of scar at day 0, 14-16, 28-30, 60 days Patient and observer scar assessment scale (POSAS),adverse effects at day 0, 14-16, 28-30, 60 days erythema, edema, burning and stinging, pustule, oozing/crusting,Histopathological change 60 day skin biopsy/ Imaging mass microscope