24hrs skin sensitivity patch test on healthy human volunteers

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/08/004895
• Date of registration: 20-08-2014
• Prospective Registration: No
• Primary sponsor: ITC Life Sciences Technology Centre Bangalore
• Public title: 24hrs skin sensitivity patch test on healthy human volunteers
• Scientific title: Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types. - Nil
• Date of first enrolment: 06-08-2014
• Target sample size: 24
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9855
• 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: Dr Sapna R
• Affiliation: MS Clinical Research Pvt Ltd

• Name: Dr Sapna R
• Affiliation: MS Clinical Research Pvt Ltd

Key inclusion & exclusion criteria

Inclusion criteria: •Subjects in age group 18 - 55 years (both the ages inclusive).

•Healthy male & female subjects.

•Subjects with Fitzpatrick skin type III to V.

•Subjects willing to give a written informed consent.

•Subjects willing to maintain the patch test in position for 24 hours.

•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 with dose >10mg/day.

•Subjects participating in any other cosmetic or therapeutic trial.

•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: Product1 Cologne
Product2 Cologne
Product3 Cologne
Product4 Cologne
Product5 Deodorant
Product6 Deodoront
Product7 Deodoront
Product8 Toner
Product9 Soap
Product10 Soap
Product11 Soap
Product12 Soap
Product13 Soap
Product14 Soap
Product15 Soap
Product16 Soap
Product17 Soap: The 40 micro liter(After dilution for respective products as per EC Approved protocol)of each products will be loaded in IQ chambers and same will be pasted on the upper back of volunteers(between scapula and waist).The patch will be kept for 24 hrs
All products would be used simultaneously.
Control Intervention1: 3% Sodium Lauryl Sulphate: 40 microliter of 3% SLS will be applied on upper back of volunteers using IQ chambers. The patch will be kept for 24 hrs

Primary Outcome(s)

To evaluate the dermatological safety of the given investigational products on healthy human volunteers of varied skin types.Timepoint: To evaluate the dermatological safety of the given investigational products on healthy human volunteers of varied skin types.

Secondary Outcome(s)

NilTimepoint: NIL

Secondary ID(s)

MSCR/ITPT/2014-08

Source(s) of Monetary Support

ITC Life Sciences & Technology Centre, Bangalore.

Ethics review

Status: Approved
Approval date: 30/07/2014
Contact:

CLINICOM, Ethics Committee