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Study of effectiveness of a skin whitening cream on 40 adult female volunteers for 6 weeks

ASSESSMENT OF THE EFFICACY OF A SKIN WHITENING COSMETIC PRODUCT OVER 6 WEEKS BY 40 FEMALE ADULT SUBJECTS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/02/003426
Enrollment
46
Registered
2013-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: skin whitening topical cosmetic product: One FTU (finger tip unit, 0.5 gm) to be applied) twice daily to the whole face and massaged for 5 to 6 times with the help of four finger tips o

Sponsors

The Himalaya Drug Company
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -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

Exclusion criteria

Exclusion criteria: -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

Design outcomes

Primary

MeasureTime frame
To evaluate the skin whitening effects of a cosmetic product for: - Reduction in dark spots and skin blemishes - Reduction of under eye dark circles - Reduction in excessive sebum secretion - Reduction in fine lines on face - Enhancement of facial skin tone, as illustrated by a shade card assessmentTimepoint: Day 0, Day 14, Day 28, Day 42

Secondary

MeasureTime frame
Measurement of skin hydration effects by CorneometerTimepoint: Day 0, 14, 28, 42;Subjective evaluation questionnaireTimepoint: Day 14, 28, 42

Countries

India

Contacts

Public ContactRashi Nangia

CIDP Biotech India Pvt. Ltd.

m.bakshi@cidp-cro.com01140793385

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026