healthy volunteer Dissolving microneedle Irritation Transdermal drug delivery
Conditions
Interventions
n the induction phase, 28 healthy participants was applied by 600 nm, 1500nm nPatch, sodium lauryl sulfate patch(positive control) and petroleum patch(negative control) on their volar forearms for 24
Experimental Device
nPatch dissolving microneedle
Sponsors
Division of Dermatology, Department of internal medicine, Faculty of medicine, Thammasat University
National Nanotechnology Center, National Science and Technology Development Agency
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| skin recovery every visits after remove patches Transepidermal water loss | — |
Countries
Thailand
Contacts
Public ContactWareeporn Disphanurat
Division of Dermatology, Department of internal medicine, Faculty of medicine, Thammasat University, Thailand
Outcome results
None listed