None listed
Conditions
Interventions
Intervention1: 24883 Day Cream SPF40 with Night cream A (24191): Day Cream:0.5g (or a pea size amount) of Day Cream to be applied to each half face left and right (cheek, forehead, nose, chin and ja
Sponsors
Oriflame Research and Development Ltd
CIDP Biotech India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Healthy Indian subjects, • Sex: female, • Age: 18 â?? 65 years old, • Subject having at least one of the following on both the left and right profiles of the face - moderate melasma - a dark spot severity score of 1-3 according to the Spot Contrast scale (Skin Ageing Atlas, Asian type by Bazin and Doublet) - moderate Post Acne hyperpigmentation • Fitzpatrick skin types III â?? V, • Subject not using skin lightening facial product at least 12 weeks prior to trial, • Subject having given freely and expressly her informed consent, cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol can be expected, • Subject who is able to read and understand documents transmitted (consent and information sheet), • Subject accepting not to apply cosmetic products other than those she usually applies and at their usual frequency of application, • Subject having access to health services.
Exclusion criteria
Exclusion criteria: • Subject who is unwilling or unable to give informed consent or to otherwise comply with protocol requirements, • Subject who is pregnant or nursing or who is planning a pregnancy during the study, • Subject exhibiting active acne, • Subject who is acne prone, • Subject having started, changed or interrupted any hormonal treatment (contraceptive, HRT, thyroid) during the past 3 months or intending to change during the study, • Subject having taken within 12 weeks prior to the study any systemic antibiotics, steroids, or any oral anti acne medications such as retinoids within 6 months prior to the study, • Current use of immunosuppressive drugs and/or an organ transplant, • Current use of topical or systemic anti-inflammatory drugs for a defined medical condition, e.g. aspirin, ibuprofen, corticosteroids, • Currently receiving allergy injections, final injection within the last week, or expecting to begin injections during the course of the study, • Insulin-dependent diabetes, • Immune deficiency or autoimmune disease, • Skin disorders affecting the study area which, in the investigatorâ??s judgment, would interfere with the grading / assessment of the skin response (e.g. acne, psoriasis, scars, hyperhidrosis, etc, â?¦), • Subjects with any skin disorder that could compromise evaluation of skin reactions, • Vaccination during the three weeks preceding the study or intention to be vaccinated during the course of the study, • Current participation in another clinical study of any kind, • Subject who cannot be contacted in case of emergency, • Febrile disease in the three days preceding the study, • Personnel of the investigating laboratory
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical scoring by the dermatologist investigator on the evolution of the different types of hyperpigmentations, according to defined scales 2. Image analysis of the images captured for the front, left and right profiles of subjects face with VISIA-CR, under standard-2 and cross-polarized light. 3. Subjective evaluation of the anti-hyperpigmentation and lightening effects of the investigational products and of its cosmetic acceptability by the subjectsTimepoint: Day 0, Day 28, Day 56 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Report of intolerance sensations.Timepoint: Day 0, Day 28, Day 56 and Day 84 | — |
Countries
India
Contacts
Public ContactDr Aalok Makker
CIDP Biotech India Pvt. Ltd.
Outcome results
None listed