Efficacy and Safety of Microneedle Patch Containing Triamcinolone Acetonide in the Treatment of Inflammatory Acne

Phase 2

Completed

• Conditions: Inflammatory acne; inflammatory acne; microneedle; triamcinolone acetonide

• Registration Number: TCTR20211215006
• Lead Sponsor: Faculty of Medicine Srinakharinwirot University

Brief Summary

This present study demonstrated that microneedle patch is effective in treatment of inflammatory acne. It is safe with no side effect reports and could be considered as an alternative treatment of inflammatory acne. Further study of 1000 um MNTA at variable amount of triamcinolone in comparison to intralesional steroid injection is suggested.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-15
• Study Completion: 2022-06-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Male or female aged more than 18 year-old
2. At least four facial inflammatory papules or pustules
3. Willingness to volunteer to participate in the trial and sign the informed consent form

Exclusion Criteria

1. Acne extraction or intralesional steroid injection within 2 weeks
2. Ablative or non-ablative lasers on face within 2 weeks
3. Dermatitis, photodermatitis or skin injection on face
4. Pregnant or lactating women
5. Unable to follow up as required

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to resolution of inflammatory acne At day 2, 3, 7, 14, 28 after treatment Physician grading

Secondary Outcome Measures

Name	Time	Method
Changing in diameter of inflammatory acne (millimeter) at day 2, 3, 7, 14, 28 after treatment Measure diameter of acne by Vernier caliper, Changing in volume of inflammatory acne (cubic millimeters) at day 2, 3, 7, 14, 28 after treatment Measure volume of acne by antera 3D,Changing in erythema index (A* value) at day 2, 3, 7, 14, 28 after treatment Erythema index by Colorimeter,Changing in melanin index (L* value) at day 2, 3, 7, 14, 28 after treatment Melanin index by Colorimeter,Safety and side effects at day 2, 3, 7, 14, 28 after treatment Patients' reports (irritation, pain, infection, bruising, skin atrophy, hyperpigmentation and hypopigmentation),Patient and physician satisfaction at day 7 after treatment Visual analogue scale,Patient preference at day 7 after treatment Questionnaire