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To evaluate the safety of 4 test products for skin irritation

Evaluation of skin safety of 4 test products 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/2021/08/035459
Enrollment
28
Registered
2021-08-05
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: Minoxifin Topical Solution: 0.04 ml of diluted test product will be filled in wells of the patch chambers. Then it will be occluded. Duration of occlusion will be 24 hours. Intervention

Sponsors

Mosaic Wellness Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Voluntary men and women (preferably equal number of males and females) between 18 and 65 years. Fitzpatrick skin type III to IV. Having apparently healthy skin on test area.

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 cutaneous tolerance by dermatological scoring of skin reactions using Draize scaleTimepoint: 48 hours scoring—

Secondary

MeasureTime frame
NilTimepoint: Nil—

Countries

India

Contacts

Public ContactAbhinav Gupta

Mosaic Wellness Private Limited

abhinav@mosaicwellness.in8879972102

Outcome results

None listed

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