Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types.

ITC Life Sciences and Technology Centre0 sites26 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 19, 2019

Last Updated

4 years ago

Study Type

Interventional

Sponsor

ITC Life Sciences and Technology Centre

•1\.Healthy male and female subjects in the age group of 18\-55 years (both age inclusive).
•2\.Subjects with Fitzpatrick skin type III to V.
•3\.Subjects with good general health as determined by the Investigator on the basis of medical history.
•4\.Subjects willing to give a voluntary written informed consent.
•5\.Subjects willing to maintain the test patches in designated positions for 24 Hours.
•6\.Subjects having not participated in a similar investigation in the past two weeks.
•7\.Subjects willing to come for regular follow up visits.
•8\.Subjects ready to follow instructions during the study period.
•9\.Subjects without any open wounds, cuts, abrasions, irritation symptoms.

•1\.Female subject is pregnant, planning for pregnancy, or lactating.
•2\.Subject having skin irritation, pigmentation, pimple, excessive hair, mole, blemishes, marks (e.g. tattoos, scars, sunburn), or any dermatological condition that can interfere with the reading on test sites.
•3\.Medication which may affect skin response and/or past medical history.
•4\.Subject having history of diabetes.
•5\.Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
•6\.Subject suffering from any active clinically significant skin diseases which may contraindicate.
•7\.Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
•8\.Participation in any patch test for irritation or sensitization within the last four weeks.
•9\.Subject having history of Bronchial Asthma.
•10\.Subject with Self\-reported Immunological disorders such as HIV, AIDS and systemic lupus erythematous.