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To test the safety of 3 test products for skin irritation

Evaluation of Skin Safety of 3 topical formulations (Minoxidil 5%) 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/2020/08/027431
Enrollment
60
Registered
2020-08-27
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: Anasure 5%: 0.04 ml will be filled and occluded for 24 hours Intervention2: Minichek 5%: 0.04 ml will be filled and occluded for 24 hours Intervention3: Mintop 5%: 0.04 ml will be appl

Sponsors

Sun Pharmaceutical Industries Ltd
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 ContactDr Suyog Mehta

Sun Pharmaceutical Industries Ltd.

Suyog.Mehta@sunpharma.com09987521040

Outcome results

None listed

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