Study of effectiveness of a skin whitening cream on 40 adult female volunteers for 6 weeks
- Registration Number
- CTRI/2013/02/003426
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
Female subjects
-Age: 18 to 55 years; both inclusive
-A subject having given written consent of her free, informed and specific willingness to participate
-Subjects having skin phototype III, IV and V
-Subjects having dark spots, freckles, pigmented
demarcation lines, and uneven tone
-Subjects having under-eye dark circles with a
score >=2
-Subjects having visible fine lines on face
-A subject having good physical health as
determined by the Investigator
-A cooperative subject informed of the importance
and the duration of the controls, enabling complete respect of the protocols established by the Clinical Centre
-Female participants must have a negative
pregnancy test at screening visit and willing to use acceptable contraceptive measures during the study
-Female subject who is pregnant or breast-feeding
(or planning to get pregnant during the study)
-A known history or present condition of allergic
response to any cosmetic products
-Subject having skin diseases (e.g. moderate to
severe acne vulgaris on face or nodulocystic acne,
psoriasis, active atopic dermatitis, pigmented
contact dermatitis or other cutaneous
manifestations), which can interfere with the test
readings
-Subjects taking oral contraceptive or any hormonal treatment since less than 1.5 month
-Any treatment, topical or systemic, taken in the
weeks preceding the test, which is likely to
interfere with the evaluation of the efficacy of the product(s) being studied
-Subjects undergoing anti-inflammatory, corticoids
or retinoids therapy by oral way
Subject having used depigmenting products, masks
exfoliant product on the studied zone in last 4
weeks
-Excessive exposure to sunlight (sun bathing,
swimming, prolong sun exposure) or UV-rays
within the previous month and during the study
-Subject who has been deemed by the investigator
as potentially unable or unwilling to comply with
the protocol
-Subject enrolled in another clinical trial during the study period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the skin whitening effects of a cosmetic product for: <br/ ><br>- Reduction in dark spots and skin blemishes <br/ ><br>- Reduction of under eye dark circles <br/ ><br>- Reduction in excessive sebum secretion <br/ ><br>- Reduction in fine lines on face <br/ ><br>- Enhancement of facial skin tone, as illustrated by a shade card assessmentTimepoint: Day 0, Day 14, Day 28, Day 42
- Secondary Outcome Measures
Name Time Method Measurement of skin hydration effects by CorneometerTimepoint: Day 0, 14, 28, 42;Subjective evaluation questionnaireTimepoint: Day 14, 28, 42