A clinical study to evaluate safety andEffectiveness of the Elure advanced skin whitening products (Advanced whitening lotion andAdvanced whitening night cream) in imparting skin fairness on healthy human volunteers.
- Registration Number
- CTRI/2012/01/002363
- Lead Sponsor
- Syneron P Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Female subjects in generally good health.
Subject can read and comprehend with the English informed consent form.
Subjects of skin types III, IV, and V.
Subjects age group 18 - 60 years
Subjects willing to give a written informed consent and come for a regular follow up.
Subject willing to abide by and comply with the study protocol
Subject has not participated in a similar investigation in the past four weeks.
Subjects having post inflammatory hyperpigmentation, freckles, pigmented demarcation lines, and uneven tone skin will also be included.
The subject will be enrolled after the sensitivity test is negative for all the sites
A known history or present condition of allergic response to any cosmetic products.
Subject having skin diseases (e.g. moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, active atopic dermatitis, melasma, lichen planus pigmentosus/ Achy dermatosis, pigmented contact dermatitis or other cutaneous manifestations), which will interfere with the test readings.
Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy.
Subjects not willing to discontinue other fairness/whitening/ brightening creams including vitamin A derivatives.
Subjects who are pregnant, lactating or nursing.
Hypersensitivity to any component of the tested products.
History of intense sun exposure.
Chronic illness which may influence the cutaneous state.
Subject participating in any other cosmetic or therapeutic trial.
Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.
Subject having any sensitive reaction to the investigational product- Skin Sensitivity test.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Improvement in whitening property of skin in comparison to baseline. <br/ ><br>2.Improvement in melanin values in Mexameter readings in comparison to baseline readings. <br/ ><br>3.Improvement in L value in Chromameter readings in comparison to baseline readings. <br/ ><br>Timepoint: Day 1, Day 15, Day 28, Day 56, Day 84
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil