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To evaluate safety of 3c test products for skin irritation.

Evaluation of Skin Safety of 3 topical formulations (Minoxidil 5% and Finasteride 0.1%) 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/2021/08/035395
Enrollment
60
Registered
2021-08-04
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: Minoxidil 5% and Finasteride 0.1% topical solution : 0.04 ml will be filled and occluded for 24 hours Intervention2: Morr-F: 0.04 ml will be filled and occluded for 24 hours Interventi

Sponsors

Sun Pharmaceutical Industries Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Fitzpatrick skin type III to IV. 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 trial.

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 hour scoring—

Secondary

MeasureTime frame
NilTimepoint: Nil—

Countries

India

Contacts

Public ContactDr Amit Thavkar

Sun Pharmaceutical Industries Ltd.

priyank.Shah1@sunpharma.com7030271166

Outcome results

None listed

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