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Closed Patch Test (24 hrs)to assess dermatological safety of test products.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/03/003474
Enrollment
24
Registered
2013-03-12
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: Product1 Lip Formulation. Product2 Lip Formulation. Product3 Talcum Powder. Product4 Hair Tonic Formulation. Product5 Face wash. Product6 Face Wash. : Dose:40 microliters of 8% Soluti

Sponsors

ITC R D Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Subject age group 18-55 years. -Healthy Male and Female Volunteers. -Subject with skin type III and IV. -Subject willing to give a written Informed consent. -Subject willing to maintain the patch test in position for 24 hrs. -Subject has not participated in similar investigation in the past two weeks. -Subject willing to come for regular follow up. -Subject ready to follow instructions during the study period.

Exclusion criteria

Exclusion criteria: -Infection, Allergy on tested area. -Skin allergy antecedents or atopic subjects. -Hyper sensitivity to any component of the tested products. -Athletes and subjects with history of excessive sweating. -Cutaneous disease which may influence the study result. -Chronic illness which may influence the cutaneous state. - 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.

Design outcomes

Primary

MeasureTime frame
To evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test.Timepoint: 9 Days for each subject.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDrMukta Sachdev

MS Clinical Research Pvt.Ltd.

mukta.sachdev@mscr.in918040917253

Outcome results

None listed

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