Detachable Dissolvable Microneedles Patch Test in Detecting Contact Allergy Contact allergy, Allergic contact dermatitis, Patch test, Microneedles patch
Conditions
Interventions
All participants will undergo the specific allergens loaded DDMNs patches application on the back of the participant, where one, randomly chosen side. Once applied, the DDMN patch will be hydrated wit
Experimental Device,Active Comparator Device
Detachable Dissolvable Microneedles Patch Test (DDMNs PT),Standard Patch test
Sponsors
Research and International Relations Division, Srinakharinwirot University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects must be at least 18 years of age. 2. Subjects with allergic contact dermatitis who had positive patch test to at least one of the 3 tested allergens (3 months before) 3. Subjects voluntarily agree to participate in this research project and have documented their consent by signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Participants with any medical condition that could potentially interfere with the results of the patch test ; a. Severe of generalized active dermatitis b. Taking systemic immunosuppressive agents, including but not limited to corticosteroids, azathioprine, cyclosporine, in relevant doses within 4 weeks. c. Dermatitis on the back or other sites chosen for the application of patch test. d. Ultraviolet exposure of the test area within 21 days. e. Test area treated with topical corticosteroids within 14 days. f. Known 3+ (extreme) patch reactions to a substance 2. Female participant who is pregnant or lactating 3. History of anaphylaxis 4. Participants who have participated in another research trial involving an investigational product (microneedles).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of DDMNs Patch test in Detecting Contact Allergy at 72 hours after placement Clinical scoring of allergic patch test reactions (by ICDRG) | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction at day 7 and day 28 after the intervention Patient reported outcome using a visual analog scale (VAS),Pain (Adverse effects of DDMNs Patch test) within 5 mins after placement of DDMNs Patient reported outcome using a visual analog scale (VAS),Skin hyperpigmentation (Adverse effects of Patch test) at day 14 and day 28 after the intervention a 3-point scale (0,1,2),Persistent positive reaction (Adverse effects of Patch test) at day 14 and day 28 after the intervention Evaluated by researcher | — |
Countries
Thailand
Contacts
Public ContactChotinij Lertphanichkul
Faculty of Medicine, Srinakharinwirot University
Outcome results
None listed