Skip to content

To study the effect of fairness cream in healthy human volunteers compared to placebo

A Phase II, randomized, double blind placebo controlled study to evaluate the efficacy and safety of Skin Lightening cream in healthy human volunteers.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/06/002710
Enrollment
30
Registered
2012-06-04
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 Lightening Cream: Frequency:Twice daily- morning and night. Dose:0.5 gms per application. Duration of application: 42 days Control Intervention1: Placebo: Frequency:Twice daily- mo

Sponsors

Sami Labs
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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.

Design outcomes

Primary

MeasureTime frame
a. Primary objective To assess product efficacy by overall lightening of skin tone in comparison to baseline and placebo by following parameters: â?¢ Dermatologistâ??s assessment â?¢ Instrumental measurements- mexameter, chromameter Timepoint: 6 Weeks

Secondary

MeasureTime frame
b. Secondary objective â?¢ 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 â?¢ Assessment for adverse eventsTimepoint: 6 Weeks.

Countries

India

Contacts

Public ContactDr Mukta Sachdev

MS CLINICAL RESEARCH PVT.LTD

mukta.sachdev@mscr.in9180-40917253

Outcome results

None listed

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