None listed
Conditions
Interventions
Intervention1: Test Arm- Bactorub Disinfectant (Investigational Product): 40 l of investigational product (without dilution) on the pre-cut filter paper placed inside the allotted derma proof Aluminiu
Sponsors
Ross Lifescience Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Able and willing to provide written informed consent. 2.Available for entire 6 8-week study duration. 3.Fitzpatrick skin type (III V). 4.Healthy intact skin on test sites (upper back/volar forearm) without sunburn, wounds, or active dermatitis. 5. Willing to refrain from new topical or systemic skin treatments during study. 6.Agree to avoid sun exposure, swimming, and vigorous exercise during patching periods.
Exclusion criteria
Exclusion criteria: 1.Active flare of eczema/atopic dermatitis, psoriasis, acne, or infection on the test site. 2.Known hypersensitivity to adhesives, occlusive patches, or any study product ingredients. 3.Systemic corticosteroid, immunosuppressive, or antihistamine therapy within 14 days. 4.Topical corticosteroid or retinoid use on test site within 7 days. 5.History of keloid scarring or poor wound healing. 6.Pregnancy or lactation. 7.Participation in another investigational study within 30 days. 8.Any condition judged by 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 incidence of dermal sensitization reactions.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