None listed
Conditions
Interventions
Intervention1: Skin lightening topical cream: One FTU (Finger Tip Unit i.e. approximately 0.5 gms on entire face) two times daily on face, morning and night after cleaning the face for 8 weeks
Control
Sponsors
LOreal India Pvt Ltd Research Innovation R I
CIDP Biotech India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Indian female subjects, aged 18-60 years (approximately 80% of total population is between 18 to 45 years age) • All skin types (50% having sensitive skin) e.g. fair, wheatish, brown and dark brown with equal distribution of skin type across the group • Subjects having pigmented spots and at least 1 well defined and homogenous spot on face and visible pores on cheek, presenting vascular homogeneity • Subjects not applying any skin whitening product prior to 6 weeks of the start of the study • Able to give written informed consent and to comply with the requirements of the study
Exclusion criteria
Exclusion criteria: • Any significant skin pathology in the test areas, like rosacea, severe acne, eczema & melasma • Known hypersensitivity to the any of the study products or constituents • Any topical or systemic treatment that could interfere with the study treatments/assessments (antibiotics, corticosteroids, retinoids, antiinflammatory drugsâ?¦) within the last 4 weeks prior to participation in the study, and during the study • Any surgical treatment on the test areas (laser peel, dermabrasion, etc.) • Subject reported or planning to sun-bath or to overexpose to UV-light (mountains sports, phototherapy, tanning salon use, etc.) for aesthetic or therapeutic reason the month before the study start or during the study • Any significant medical condition that would interfere in the participation in the trial • Participation in a clinical trial up to 1 month prior to inclusion • Pregnant women (as confirmed by UPT) and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ô??¹ Evaluation of the color of a selected dark spot and its adjacent spotless area + contrast spot/ spotless area ô??¹ Evaluation of pores visibility at T0-T4 ws, T8 ws ô??¹ Evaluation of the pigmentary homogeneity ô??¹ Evaluation of the vascular homogeneity ô??¹ Evaluation of skin tone using standard shade card developed ô??¹ Chromameter evaluation of the color of a selected dark spot and its adjacent spotless area and contrast ô??¹ Digital Photography using Visia-CRTimepoint: T0, T4 ws, T8 ws | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse events of the treated skin areas for signs and symptoms of skin irritation or sensitisationTimepoint: T0, T4 ws, T8 ws;Self assessment according to shade card to be done by the subject as well as assessment by the InvestigatorTimepoint: T0, T4 ws, T8 ws;Self evaluation questionnaire to be filled by the subject: according to a 5 point scaleTimepoint: Timm, T1 wk, T2 ws, T4 ws, T8 ws | — |
Countries
India
Contacts
Public ContactDr Aalok Makker
CIDP Biotech India Pvt. Ltd.
Outcome results
None listed