None listed
Conditions
Interventions
Intervention1: 1. Anti Acne Product-Z331: Product A
2. Anti Acne Product-Y973: Product B
: Product A & B are skin care formulation which have tobe applied on the acne lesions on face.
Control Inter
Sponsors
ITC LIMITED ITC Life Sciences and Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: Healthy Indian / Asian male and female subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) Male and female volunteers in the age group of 19 to 35 years with acne of mild and moderate severity. Volunteer willing to participate in the study and provide signed informed consent for the same Subjects who has tolerated the IP well showing no sensitivity symptoms during the sensitivity test.
Exclusion criteria
Exclusion criteria: � Volunteers hesitant to sign on Informed consent forms � Volunteer who is insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) � Volunteer having a progressive asthma (either under treatment or last fit in the last 2 years) � Volunteer having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) � Volunteer having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) � Volunteer who is epileptic � Volunteer following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted isparacetamol) � Volunteer having cutaneous hypersensitivity � Volunteer having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products � Volunteer having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months � Volunteer having changed her/his cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit � Volunteer having any genetic and endocrinal disorders as disclosed by volunteers � Volunteer having acne of severe incidence (presence of Nodules, Cysts or numerous pustules) which requires pharmaceutical treatment � Volunteer having allergy to Retinol � Female volunteers who are Pregnant or lactating . � Volunteer having started, changed or stopped a hormonal treatment or taken an oral retinoid-based treatment or having undergone a physical (phototherapy, laser ..) or chemical (peeling) treatment for acne in previous 6 months. � Volunteer having had a local benzoyl-peroxide-based treatment, Clindamycin, AHA or a local retinoid-based treatment or oral treatment with a base of cimetidine, zinc (zinc gluconate) or spironolactone in previous month � Volunteer having applied cosmetic products with anti-seborrheic aims or cosmetics for oily skin or oral/local antibiotic treatment for acne in two previous weeks. � Volunteer having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask �) or suntanned skin on the studied areas which could interfere with the evaluations of the study in previous week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Screening Day 1 , Screening Day 2, T0 ( Baseline),T+4 hrs after Product application, T+1 day, T+2 days, T+7 days, T+14 days and T+28 days visitTimepoint: Screening Day 1 , Screening Day 2, T0 ( Baseline),T+4 hrs after Product application, T+1 day, T+2 days, T+7 days, T+14 days and T+28 days visit | — |
Secondary
| Measure | Time frame |
|---|---|
| not applicableTimepoint: not applicable | — |
Countries
India
Contacts
Public ContactMr Mohit Lalvani
MASCOT-SPINCONTROL India Pvt. Ltd.
Outcome results
None listed