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Evaluation of safety of skin bleaching products by single open application test on human subjects

Evaluation of dermatological safety of skin bleaching products by single open application test on healthy female subjects belonging to the age group 18-50 years. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/08/006088
Enrollment
24
Registered
2015-08-12
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: Total 6 bleaching products: Approximately 100 microliter of of each bleaching product will applied below and above side of cubital fossa of the left hand using a spatula. Control Interv

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Healthy female subjects in age group 18 - 50 years (both the ages inclusive). •Subjects with Fitzpatrick skin type III to V. •Subjects who are not allergic to bleaching products as per medical history. •Subjects willing to give a voluntary written informed consent. •Subject having not participated in a similar investigation in the past two weeks. •Subjects willing to come for regular follow up visits. •Subjects ready to follow instructions during the study period.

Exclusion criteria

Exclusion criteria: •Infection, allergy on the tested area. •Skin allergy, antecedents or atopic subjects. •Athletes and subjects with history of excessive sweating. •Cutaneous disease which may influence the study result. •Subjects on oral corticosteroid >10mg/day. •Subjects participating in any other cosmetic or therapeutic study. •Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

Design outcomes

Primary

MeasureTime frame
To evaluate the dermatological safety of the investigational products on healthy human subjects.Timepoint: Approximately 9 day for each subject

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDrRachana Shilpakar

MS Clinical Research Pvt Ltd

rachana.shilpakar@mscr.in8040917253

Outcome results

None listed

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