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Safety Testing of cosmetic product by Patch test

Evaluation of Dermatological safety of Test 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/2021/04/032587
Enrollment
24
Registered
2021-04-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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. Baby Nappy Rash Cream 2. Baby talcum Powder 3. Baby Oil 4. Baby Lotion 5. Baby Shampoo 6. Baby Shower gel: 1. For product 1, 3, 4 the product is leave on product, so is placed direct

Sponsors

Freedom Fragrances
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy male and female subjects in the age group of 18-45 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 a history of excessive sweating 5. Subjects on an 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 at 0 hour, 24 hours and 7 days post patch removal.Timepoint: Safety assessment of investigational products for irritation potential using draize scale.

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactRajat Gupta

Auriga Research Private Limited

drurvi77@gmail.com01244006445

Outcome results

None listed

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