None listed
Conditions
Interventions
Intervention1: Test Arm- Maxo Mosquito Repellant Cream (Investigational Product): 40 g of investigational product (without dilution) on the pre-cut filter paper placed inside the allotted derma proo
Sponsors
Jyothy Labs Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Able and willing to provide written informed consent 2.Available for the entire 6 to8 week study duration 3.Fitzpatrick skin type 3 to 5 4.Healthy intact skin on test sites (upper back or volar forearm) without sunburn, wounds or active dermatitis 5.Willing to refrain from new topical or systemic skin treatments during the study 6.Agree to avoid sun exposure, swimming and vigorous exercise during the patching period
Exclusion criteria
Exclusion criteria: 1.Active flare of eczema/atopic dermatitis, psoriasis, acne, or infection on the test site. 2.Presence of suspected allergic contact dermatitis or chronic dermatitis where contact allergy is clinically suspected. 3.Known hypersensitivity to adhesives, occlusive patches, or any study product ingredients. 4.Systemic corticosteroid, immunosuppressive or antihistamine therapy within 14 days. 5.Topical corticosteroid or retinoid use on test the site within 7 days. 6.History of keloid scarring or poor wound healing. 7.Pregnancy or lactation or having stopped to breastfeeding in the past three months. 8.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 9.Having applied a cosmetic product (including make-up) on the studied areas 48 hours prior to the study. 10.Having consumed caffeine-based products (coffee, cola, tea, ), alcohol, highly spiced food, and/or smoke in the two hours preceding the measurements. 11.Having practiced intensive sports during the day prior to the T0 measurements 12.Having wounds, scars, sunburns, tattoos and piercings on the test site. 13.Participation in another investigational study within 30 days. 14.Any condition judged by the investigator to interfere with the test or safety evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety of the investigational product (IP) and record the incidence of dermal sensitization reactions following HRIPT.Timepoint: Day 1 to Day 40 | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt Ltd
Outcome results
None listed