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24hrs skin sensitivity patch test on healthy human volunteers.

Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin type. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/012122
Enrollment
24
Registered
2018-02-23
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 Oil Product2 Oil Product3 Oil Product4 Cream Product5 Lotion Product6 Solution: The 40 micro liter of each products will be loaded in IQ chambers and same will be pasted on th

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1Subjects in age group 18 - 55 years. 2Healthy 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. 9.Subjects with sensitive skin type as per the score obtained on the skin type identification questionnaire in annexure-I and by dermatological evaluation for the confirmation of the same.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjectsTimepoint: 0hr,24hr and 7days post patch removal

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Sapna R

MS Clinical Research Pvt Ltd

sapna.r@mscr.in918040917253

Outcome results

None listed

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