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Safety Evaluation of test products by Primary Irritation Patch Test for Sensitive Skin (Single Application 24-hour Occlusion)

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070924
Enrollment
26
Registered
2024-07-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

None listed

Interventions

Intervention1: Mamaearth Rice Water Moisturizing Body Wash: 8%w/v sample solution, 0.04mg, single dose, topical application, 24 hr Intervention2: Mamaearth Vitamin C Moisturizing Body Wash: 8%w/v samp

Sponsors

Honasa Consumer Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Participants with normal Fitzpatrick skin type III to V. (Human skin colour determination scale). 2) Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application. 3) Participants scoring greater than 30 for Section 2- Sensitive versus Resistant skin in modified Dr. Baumann’s skin type questionnaire. 4) Participants who do not have any previous history of adverse skin conditions and are not under any medication are likely to interfere with the results. 5) Participants are in good general health as determined by the Investigator on the basis of medical history.

Exclusion criteria

Exclusion criteria: 1) Participants 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 site(s) i.e. back that can interfere with the reading. 2) Participant 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. 3) Participant suffering from any active clinically significant skin diseases which may affect the study results. 4) Participant having history of any skin diseases including eczema, atopic dermatitis. 5) Participation in any patch test for irritation or sensitization within the last four weeks. Participation in other patch study simultaneously.

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 Parth Joshi

Cliantha Research

ssethi@cliantha.com9825784942

Outcome results

None listed

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