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Primary Irritation Patch Test on Healthy Adult Human Subjects with Normal Skin.

Evaluation of Dermatological Safety of Test Products by 24 hours Patch Test under Complete Occlusion on Adult Healthy Human Participants with Normal Skin. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061088
Enrollment
26
Registered
2024-01-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Staze 9 to 9 All Eyes On You Kajal Blackest Black (01) 0.3 g: Neat, 0.04mg, single dose, topical application, 24 hr Intervention2: Staze 9 to 9 All Eyes On You Liner Blackest Black (01)

Sponsors

Honasa Consumer Pvt. Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1Males and non-pregnant or non-lactating females preferably equal numbers of males and females between age group of 18 to 65 years both inclusive at the time of consent. 2Participants with normal Fitzpatrick skin type three to five. 3Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application. 4Participants who do not have any previous history of adverse skin conditions and are not under any medication are likely to interfere with the results. 5Participants are in good general health as determined by the Investigator on the basis of medical history.

Exclusion criteria

Exclusion criteria: 1Participants having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks e.g. tattoos, scars, sunburn, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test sites i.e. back that can interfere with the reading. 2Participant with history of asthma or COPD Chronic obstructive pulmonary disease, diabetes and mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months. 3Participant suffering from any active clinically significant skin diseases which may affect the study results. 4Participant having history of any skin diseases including eczema, atopic dermatitis. 5Participation in any patch test for irritation or sensitization within the last four weeks.

Design outcomes

Primary

MeasureTime frame
Safety assessment of productsTimepoint: 30 minutes of patch removal (Day 02), 24 hours (Day 03) and 168 hours (Day 09)

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Simran Sethi

Cliantha Research

pjoshi@cliantha.com8000085049

Outcome results

None listed

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