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Evaluation of dermatological safety of investigational products by pasting patch on the upper back of healthy human volunteers.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/01/002342
Enrollment
24
Registered
2012-01-17
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: PIPT for Vivel Fairness cream coded VTFC#4750: The product is applied to the upper back of volunteer using IQ chambers in the form of patch. Intervention2: PIPT for New shampoo AD cod

Sponsors

ITC RD Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Subjects age group 18 - 55 years • Healthy male & female volunteers • Subjects with skin type III to V. • Subjects willing to give a written informed consent. • Subjects willing to maintain the patch test in position for 24 hours • Subject has not participated in a similar investigation in the past two weeks. • Subjects willing to come for regular follow up. • Subjects ready to follow instructions during the study period.

Exclusion criteria

Exclusion criteria: • Infection, allergy on the 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.

Design outcomes

Primary

MeasureTime frame
The objective of this study is to evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by dermatological visual assessment.Timepoint: 0HRS, 24HRS, 1WEEK ASSESSMENT

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactDr Mukta Sachdev

MS Clinical Research Pvt. Ltd

mukta.sachdev@mscr.in80-91-40917253

Outcome results

None listed

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