Irritation and sensitization potential of novel dissolving microneedle patch : in vivo study
- Conditions
- healthy volunteerDissolving microneedleIrritationTransdermal drug delivery
- Registration Number
- TCTR20220127002
- Lead Sponsor
- Division of Dermatology, Department of internal medicine, Faculty of medicine, Thammasat University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 28
1. Healthy male or female participants, aged 18-65.
2. Participants who are willing to join the project after receiving a detailed description of the project and signing a consent form for the study.
3. 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.
1. Participants who are pregnant, breastfeeding, or planning to become pregnant.
2. Participants who had history of dermatologic conditions such as atopic dermatitis, psoriasis, vitiligo, melanoma, squamous cell carcinoma.
3. Participants who had history of Diabetes mellitus, porphyria, primary immunodeficiencies, HIV, anaphylaxis, asthma, generalized drug reaction, lymphoma, leukemia.
4. Participants had a history of connective tissue disease.
5. Participants who took immunosuppressants (Immunosuppressive agents).
6. Participants who had a history of allergic contact dermatitis to Tegaderm.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Skin irritation every visits after remove patches Irritation score,Skin irritation every visits after remove patches Skin imaging(photograph),skin irritation every visits after remove patches Transepidermal water loss
- Secondary Outcome Measures
Name Time Method skin recovery every visits after remove patches Transepidermal water loss