None listed
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Skinovate Laser Cosmetic Surgery Center
Eligibility
Inclusion criteria
Inclusion criteria: 1 Males and females aged eighteen to sixtyfive years 2 Healthy as determined by medical history and investigator exam 3 Intact skin at proposed application sites no cuts infections active dermatitis 4 Fitzpatrick skin types I VI accepted 5 Able and willing to provide written informed consent and comply with study procedures 6 Women of childbearing potential must use acceptable contraception and have a negative urine pregnancy test at screening
Exclusion criteria
Exclusion criteria: 1 Pregnant or lactating women. 2 Known hypersensitivity to any ingredient in the investigational products 3 History of atopic dermatitis, chronic eczema, psoriasis, or other active skin disease affecting the test area 4 Active acneiform or follicular infection at the intended application site 5 Use of systemic retinoids within previous 6 months or topical retinoids steroids at test site within 4 weeks 6Use of systemic immunosuppressive therapy or corticosteroids within 4 weeks 7 Known photosensitivity dermatographism or severe allergic history. 8 Participation in another interventional study or receipt of an investigational product within 30 days. 9 Recent within 3 weeks vaccination or intention to be vaccinated during study perio 10 Any condition which, in the investigators opinion would interfere with the safe conduct of the study or interpretation of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary irritation as scored by the Draize scale erythema dryness wrinkling oedema recorded at Visit 2 24 h after occlusion removal and Visit 3 48 h after occlusion removal The maximum Draize score recorded per site will be used for analysisTimepoint: 24 hours and 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Incidence frequency & severity of AEs SAEs during the study period 2 Subject reported sensations at the test site non mild moderate severe for itching burning tinging Timepoint: 24 hours & 48 hours | — |
Countries
India
Contacts
Public ContactDr Sonal Shendkar
Skinovate Laser Cosmetic Surgery Center,
Outcome results
None listed