None listed
Conditions
Interventions
Intervention1: 1. Plaster 1[9740892]
2. Plaster 2 [W547]
: Product 1 & 2: The plaster to be removed from the packaging and applied on the designated test site.
Intervention2: 1. Plaster 1[9740892]: Th
Sponsors
ITC LSTC
Eligibility
Inclusion criteria
Inclusion criteria: Healthy & Clear Skin on back on the studied anatomic unit (free of psoriasis, eczema, , lichen plan, vitiligo, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies â?¦.) Male and female volunteers in the age group of 18 to 50 years in generally good health Volunteer willing to participate in the study and provide signed informed consent for the same Subjects representing varied skin types (ideally equal representation of all 4 skin types â?? Oily, Normal, Dry and combination)
Exclusion criteria
Exclusion criteria: Volunteers hesitant to sign on Informed consent forms Volunteers with known sensitivity to bandage or adhesive tape Volunteer who has participated in a similar clinical investigation in the last four weeks of study initiation Volunteer who is considered immunocompromised, or has a clinically-relevant history of or currently suffering from any disease or condition that, in the opinion of the investigator, might affect the evaluation of the study product or place the subject at undue risk Volunteers with sunburns, uneven skin tone, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality on their back that would render the site non-conducive for visual assessment. Volunteers identified with clinically-relevant skin disease, including psoriasis, eczema, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies, or a history of skin cancer, that may, in the opinion of the investigator, contraindicate participation or interfere with test site evaluations Volunteers on medication such as Antihistamines, Antifungals, Corticosteroids, Topical Steroids, etc. that might influence the study results Female volunteers who are Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the dermatological safety of investigational products by Single Application Closed patch test on healthy human volunteers of varied skin types. Timepoint: screening T0 T1day T2days T8days | — |
Secondary
| Measure | Time frame |
|---|---|
| not applicableTimepoint: not applicable | — |
Countries
India
Contacts
Public ContactMs Priya Shah
MASCOT-SPINCONTROL India Pvt. Ltd.
Outcome results
None listed