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Safety testing of products by Patch Test

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/2018/06/014456
Enrollment
24
Registered
2018-06-07
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. Skin Leave-On 4.Rinse-off 5.Skin Leave-On 6. Skin Leave-On 7. Skin Leave-On 8. Skin Leave-On 9. Skin Leave-On 10. Skin Leave-On 11. Skin Leave-On

Sponsors

ITC Life Sciences Technology Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy male and female subjects in the age group of 18-55 years (both age inclusive) 2. Subjects with Fitzpatrick skin type III to V 3. Subjects willing to give a voluntary written informed consent 4. Subjects willing to maintain the test patches in designated positions for 24 Hours 5. Subjects having not participated in a similar investigation in the past two weeks 6. Subjects willing to come for regular follow up visits 7. Subjects ready to follow instructions during the study period 8. Subjects without any open wounds, cuts, abrasions, irritation symptoms

Exclusion criteria

Exclusion criteria: 1. Subjects with Infection/ allergy/ irritation symptoms on the upper back area identified for patch application 2. Subjects with any kind of skin allergy, antecedents or atopy or cutaneous disease which may influence the study results 3. Subject is Pregnant or Lactating 4. Athletes and subjects with history of excessive sweating 5. Subjects on oral corticosteroid, or using any topical or systemic medicine which might interfere with the study results 6. Subjects participating in any other cosmetic or therapeutic trial 7. Subjects with 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
Safety assessment of investigational products for irritation potential using Draize scale.Timepoint: Safety assessment of investigational products for irritation potential using Draize scale at 0 hour, 24 hours and Day 7 post patch removal.—

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable—

Countries

India

Contacts

Public ContactRajat Gupta

CIDP Biotech India Pvt Ltd

a.jain@cidp-cro.com09582645711

Outcome results

None listed

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