Study of effectiveness of a day cream product in combination with a night cream in reducing dark spots in asian adult females over a period of 3 months
- Registration Number
- CTRI/2012/02/002420
- Lead Sponsor
- Oriflame Research and Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
• 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.
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Clinical scoring by the dermatologist investigator on the evolution of the different types of hyperpigmentations, according to defined scales <br/ ><br>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. <br/ ><br>3. Subjective evaluation of the anti-hyperpigmentation and lightening effects of the <br/ ><br>investigational products and of its cosmetic acceptability by the subjectsTimepoint: Day 0, Day 28, Day 56 and Day 84
- Secondary Outcome Measures
Name Time Method Report of intolerance sensations.Timepoint: Day 0, Day 28, Day 56 and Day 84