To study the effect of fairness cream in healthy human volunteers compared to placebo
- Conditions
- Skin Lightening study
- Registration Number
- CTRI/2012/06/002710
- Lead Sponsor
- Sami Labs
- Brief Summary
It is aPhase II, randomized double blind placebo controlled study to evaluate the efficacy and safety of skin lightening cream in healthy human volunteers.
The study aims at
a. Primary objectivexml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" / To assess product efficacy by overall lightening of skin tone in comparison to baseline and placebo by following parameters:
· Dermatologist’s assessment
· Instrumental measurements- mexameter, chromameter
**b. Secondary objective**
· To assess product performance in reduction of dark spots, blemishes and marks in comparison to baseline and placebo by evaluating photographically with Imaging system - Image pro II
· Assessment for adverse events
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
- •Male and Female subjects in generally good health •Subjects of skin types III, IV, and V. •Subjects age group 18.
- 55 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. •Subject should be willing to abstain from spa treatments/facials throughout the study period.
- •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, photosensitizing drugs.
- •Subjects not willing to discontinue other topical fairness, anti ageing, anti wrinkle facial products.
- •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 concurrently in any other cosmetic or therapeutic trial.
- •Any underlying uncontrolled medical illness such as diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a. Primary objective 6 Weeks To assess product efficacy by overall lightening of skin tone in comparison to baseline and placebo by following parameters: 6 Weeks •Dermatologist’s assessment 6 Weeks •Instrumental measurements- mexameter, chromameter 6 Weeks
- Secondary Outcome Measures
Name Time Method b. Secondary objective •To assess product performance in reduction of dark spots, blemishes and marks in comparison to baseline and placebo by evaluating photographically with Imaging system - Image pro II
Trial Locations
- Locations (1)
MS Clinical Research Pvt. Ltd
🇮🇳Bangalore, KARNATAKA, India
MS Clinical Research Pvt. Ltd🇮🇳Bangalore, KARNATAKA, IndiaDr Mukta SachdevPrincipal investigator80-40917253mukta.sachdev@mscr.in