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To evaluate safety of the products by skin sensitivity test on healthy human volunteers

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/2016/12/007525
Enrollment
24
Registered
2016-12-02
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: 1.Skin Leave-on 2.Skin Leave-on 3. Hair Leave-on 4.Talc 5.Talc 6.Talc 7.Talc 8.Talc 9.Rinse off product 10.Rinse off product 11.Rinse off product: 40µl of investigational products 1,2,

Sponsors

ITC Life Sciences and Technology Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Subjects in the age group 18 - 55 years (both the ages inclusive). 2)Healthy male & female subjects. 3)Subjects with Fitzpatrick skin type III to V. 4)Subjects willing to give a written informed consent. 5)Subjects willing to maintain the patch test in position for 24 hours. 6)Subject 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.

Exclusion criteria

Exclusion criteria: 1)Infection, allergy on the tested area. 2)Skin allergy, antecedents or atopic subjects. 3)Athletes and subjects with history of excessive sweating. 4)Cutaneous disease which may influence the study result. 5)Subjects on oral corticosteroid. 6)Subjects participating in any other cosmetic or therapeutic trial. 7)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 subjectsTimepoint: Time points 0hr, 24hr and 7days post patch removal

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDrMukesh Ramnane

MS Clinical Research Pvt Ltd

mukesh.ramnane@mscr.in918040917253

Outcome results

None listed

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