None listed
Conditions
Interventions
None listed
Sponsors
Accelia Sante Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male or female participants aged 18 to 65 years. 2. No clinically significant dermatological conditions (e.g., eczema, psoriasis). 3. Participants with clinically normal, healthy skin on the upper back (preferred test site). 4. Fitzpatrick skin types I IV. 5. Willing and able to comply with all study procedures and visit schedules. 6. Able to understand the study requirements and provide written informed consent. 7. Agree to avoid use of any topical products (cosmetics, creams, medicated products) on the test area during the study. 8. Agree to avoid excessive sun exposure, swimming, or activities that may affect the test site. 9. Willing to refrain from participation in other clinical studies during the study period.
Exclusion criteria
Exclusion criteria: 1. Known history of hypersensitivity or allergy to any component of the test product(s). 2. Presence of dermatological conditions (e.g., eczema, psoriasis, dermatitis, active skin infection) on or near the test site. 3. History of chronic skin diseases or conditions that may interfere with study evaluation. 4. Presence of cuts, scars, tattoos, sunburn, moles or excessive hair on the test site that may interfere with assessment. 5. Use of topical medications (e.g., corticosteroids, antihistamines) on the test area within 1 week prior to study initiation. 6. Use of systemic corticosteroids, immunosuppressants, or antihistamines within 4 weeks prior to study. 7. History of severe allergic reactions or anaphylaxis. 8. Participation in another clinical study within the last 4 weeks. 9. Pregnant or lactating women. 10. Any significant medical condition (e.g., uncontrolled diabetes, autoimmune disorders) that may interfere with study participation. 11. Participants with a history of keloid formation or poor wound healing. 12. Any condition which, in the opinion of the Investigator, makes the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence and severity of skin irritation reactions at the application sites during the induction phase, as assessed using a standardized grading scale (e.g., Draize scoring system). Timepoint: Day 0- Visit 1 Day 2- Visit 2 Day 3- Visit 3 Day 4- Visit 4 Day 5- Visit 5 Day 6- Visit 6 Day 7- Visit 7 Day 8- Visit 8 Day 9- Visit 9 Day 10- Visit 10 Day 11- Visit 11 Day 12- Visit 12 Day 13- Visit 13 Day 19- Visit 14 Day 20- Visit 15 Day 21- Visit 16 Day 22- Visit 17 Day 23- Visit 18 | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall dermatological tolerability, based on: Frequency, nature, and severity of local skin reactions throughout the study.Timepoint: Day 0- Visit 1 Day 2- Visit 2 Day 3- Visit 3 Day 4- Visit 4 Day 5- Visit 5 Day 6- Visit 6 Day 7- Visit 7 Day 8- Visit 8 Day 9- Visit 9 Day 10- Visit 10 Day 11- Visit 11 Day 12- Visit 12 Day 13- Visit 13 Day 19- Visit 14 Day 20- Visit 15 Day 21- Visit 16 Day 22- Visit 17 Day 23- Visit 18 ;Cumulative irritation response, evaluated across repeated applications during the induction phase.Timepoint: Day 0- Visit 1 Day 2- Visit 2 Day 3- Visit 3 Day 4- Visit 4 Day 5- Visit 5 Day 6- Visit 6 Day 7- Visit 7 Day 8- Visit 8 Day 9- Visit 9 Day 10- Visit 10 Day 11- Visit 11 Day 12- Visit 12 Day 13- Visit 13 Day 19- Visit 14 Day 20- Visit 15 Day 21- Visit 16 Day 22- Visit 17 Day 23- Visit 18;Incidence of adverse events (AEs) and their relationship to the test product(s).Timepoint: Day 0- Visit 1 Day 2- Visit 2 Day 3- Visit 3 Day 4- Visit 4 Day 5- Visit 5 Day 6- Visit 6 Day 7- Visit 7 Day 8- Visit 8 Day 9- Visit 9 Day 10- Visit 10 Day 11- Visit 11 Day 12- Visit 12 Day 13- Visit 13 Day 19- Visit 14 Day 20- Visit 15 Day 21- Visit 16 Day 22- Visit 17 Day 23- Visit 18;Participant-reported skin responses, including burning, itching, stinging, tingling and others sensations at application sites.Timepoint: Day 0- Visit 1 Day 2- Visit 2 Day 3- Visit 3 Day 4- Visit 4 Day 5- Visit 5 Day 6- Visit 6 Day 7- Visit 7 Day 8- Visit 8 Day 9- Visit 9 Day 10- Visit 10 Day 11- Visit 11 Day 12- Visit 12 Day 13- Visit 13 Day 19- Visit 14 Day 20- Visit 15 Day 21- Visit 16 Day 22- Visit 17 Day 23- Visit 18 | — |
Countries
India
Contacts
Public ContactMamatha B Gokavi
Accelia Sante Pvt Ltd
Outcome results
None listed