None listed
Conditions
Interventions
Intervention1: Hydroxy S Plus: -The active ingredient is hydrogen peroxide in water, at a concentration between 2.5 to 2.9%.
-The study product is applied via spray application directly onto intact h
Sponsors
Dr Avijit Roy
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged 18 to 65 years at enrolment 2. Participants with intact healthy skin on the upper arm or calf suitable for topical application, with no tattoos, scarring, active dermatoses, or significant pigmentation alterations in the proposed application area 3. Participants who, in the judgment of the investigator, are considered suitable for participation in this study and have the ability to complete all study visits and procedures 4. Participants who are able and willing to provide written informed consent and comply with all protocol procedures.
Exclusion criteria
Exclusion criteria: 1. Participants with poor or compromised skin integrity at or near the application site including wounds, cuts, active inflammation, moderate to severe dermatologic conditions (such as eczema, psoriasis, dermatitis, or significant sunburn), or a history of severe urticaria, anaphylaxis, or chemically induced contact dermatitis 2. Participants with known allergy or hypersensitivity to hydrogen peroxide or any of the product ingredients (excipients) 3. Participants who have used topical corticosteroids, topical immunomodulators, or other agents that may alter skin reactivity in the proposed application area within the past 7 days 4. Participants with significant respiratory disease, including moderate to severe asthma, COPD requiring daily controller medication, documented exacerbation within the past 3 months 5. Female participants who are pregnant, planning pregnancy, or currently breastfeeding 6. Participants who have participated in another interventional clinical study or received an investigational product within the past 30 days 7. Participants with any medical, psychological, or social condition that, in the judgment of the investigator, may increase risk, reduce compliance, or confound study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects exhibiting any clinical symptoms, as assessed by the International Contact Dermatitis Research Group (ICDRG) scoring system [1]. 2. To evaluate the frequency and severity of symptoms temporally associated with product use (sneezing, cough, throat irritation, wheeze, dyspnoea, ocular irritation/redness/tearing) as recorded in the subject diary.Timepoint: Time Frame: From Enrolment to Visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be assessed based on the incidence of signs and symptoms as recorded in the subject diaryTimepoint: Time Frame: From Screening to End of Study | — |
Countries
India
Contacts
Public ContactDr Chikkalingaiah Siddegowda
Medstar Specialist Hospital
Outcome results
None listed