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Patch test study on healthy human volunteers under occlusion for 24hrs

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/2018/02/012023
Enrollment
24
Registered
2018-02-21
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.Soap 2.Soap 3.Soap 4.Rinse off 5.Rinse off 6.Skin leave on 7.Skin leave on 8.Skin leave on 9.Skin leave on 10.Skin leave on: 40 µl of the investigational products 1-3 (Soap),products

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. 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: 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 >10mg/day. 6)Subjects participating in any other cosmetic or therapeutic study. 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 ContactDrRachana Shilpakar

MS Clinical Research Pvt.Ltd

rachana.shilpakar@mscr.in08041125934

Outcome results

None listed

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