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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/08/006088
• Date of registration: 12-08-2015
• Prospective Registration: No
• Primary sponsor: Dabur India Limited
• Public title: Evaluation of safety of skin bleaching products by single open application test on human subjects
• Scientific title: 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
• Date of first enrolment: 29-07-2015
• Target sample size: 24
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12554
• Study type: Interventional
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: DrRachana Shilpakar
• Affiliation: MS Clinical Research Pvt Ltd

• Name: DrRachana Shilpakar
• Affiliation: MS Clinical Research Pvt Ltd

Key inclusion & exclusion 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: •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.



Age minimum:
Age maximum:
Gender:

Intervention(s)

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 Intervention1: Vaseline: 100µl of the negative control (Vaseline, neat/ without dilution) will be dispensed on the test site above the cubital fossa of the right hand using a positive displacement pipette.

Primary Outcome(s)

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

Secondary Outcome(s)

NILTimepoint: NIL

Secondary ID(s)

MSCR/DAST/2015-01, Version 1.0 dated 03 Jul 2015

Source(s) of Monetary Support

Dabur India Limited, Plot No.22, Site IV, Sahibabad-201010, Ghaziabad (U.P.), India.

Ethics review

Status: Approved
Approval date: 25/07/2015
Contact:

Life Line Ethics Committee, Bangalore