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To evaluate safety of a test product for skin irritation

Evaluation of Skin Safety of a test product 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/2021/01/030818
Enrollment
26
Registered
2021-01-28
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: Man Matters Growmax 5%: Single Patch Application 0.04 ml will be applied on test site and will be occluded for 24 hours. Control Intervention1: 0.9% Isotonic Saline- Negative Control:

Sponsors

Mosaic Wellness Private Limited
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 Abhinav Gupta

Mosaic Wellness Private Limited

abhinav@mosaicwellness.in8879972102

Outcome results

None listed

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