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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220318004
Enrollment
10
Registered
2022-03-18
Start date
2021-02-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triamcinolone acetonide dissolving microneedle patch for hypertrophic scar or keloid triamcinolone acetonide, dissolving microneedle patch, hypertrophic scar, keloid

Interventions

Each participant was given two equal parts of the hypertrophic scar or keloid then one side of the scar was randomized for treatment with triamcinolone dissolving microneedle patch and the other side
Treatment group with triamcinolone dissolving microneedle patch,Control group with dissolving microneedle without triamcinolone

Sponsors

Division of Dermatology, Department of internal medicine, Faculty of medicine, Thammasat University
Lead Sponsor
National Nanotechnology Center, National Science and Technology Development Agency
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Scar volume at day 0, 14-16, 28-30, 60 days skin imaging analysis ( Visioscan)

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactWareeporn Disphanurat

Division of Dermatology, Department of internal medicine, Faculty of medicine, Thammasat University, Thailand

dwareeporn@gmail.com029269435

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026