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To evaluate safety of a test product for skin irritation

Evaluation of Skin Safety of 1 test product (Luliconazole & Salicylic Acid & Zinc Pyrithione Shampoo) for Primary Skin Irritation Using Skin Irritation Test (Patch Test in Humans) IS 4011:2018 Guidelines.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032171
Enrollment
60
Registered
2021-03-19
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: Luliconazole & Salicylic Acid & Zinc Pyrithione Shampoo: Single Patch Application 0.04 ml of diluted product will be applied and will be occluded for 24 hours. Control Intervention1: 1

Sponsors

Om Sai Pharma Pack
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Photo type III to V Having apparently healthy skin on test area Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study

Exclusion criteria

Exclusion criteria: Pregnancy (by history) and lactating women. Scars, excessive terminal hair or tattoo on the studied area Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye)

Design outcomes

Primary

MeasureTime frame
Evaluation of skin irritation reactions using Draize scaleTimepoint: 48 hours—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactMr Neeraj Upadhyay

Om Sai Pharma Pack

qa.head@osppgroup.com7500196600

Outcome results

None listed

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