None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1 Males and females aged 18 65 years 2 Healthy by medical history and investigator exam 3 Intact facial skin areas for patch application no cuts active dermatitis infections 4 Fitzpatrick skin types I VI accepted 5 Women of childbearing potential must use contraception and have negative pregnancy test 6 Willing to provide informed consent and comply with study procedures
Exclusion criteria
Exclusion criteria: 1 Pregnant or lactating women 2 Known hypersensitivity to ingredients in IPs 3 History of atopic dermatitis chronic eczema psoriasis affecting test area 4 Active acneiform or follicular infection at application site 5 Use of systemic retinoids within 6 months or topical retinoids steroids at site within 4 weeks 6 Immunosuppressive therapy within 4 weeks 7 Photosensitivity dermatographism severe allergy history 8 Participation in another interventional study or investigational product within 30 days 9 Recent vaccination or planned vaccination during study 10 Any condition interfering with safety or data interpretation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the primary skin irritation potential of the above Skinovate skin products in healthy volunteers after a single occluded 24hour application 2 h measured by Draize scale scores at 24 and 48-hours post-applicationTimepoint: three months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate overall safety and tolerability based on incidence frequency and severity of adverse events AEs SAEs To document subject-reported sensations at the test site itching burning stinging tightness Timepoint: three months | — |
Countries
India
Contacts
Skinovate Laser Cosmetic Surgery Center,