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To study the irritation, if any, caused by application of product on skin.

Skin Irritation Test (Patch Test in Humans) (IS 4011:2018)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021230
Enrollment
26
Registered
2019-09-13
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: Minoxidil Topical solution USP 5% w/v (Fortification): 0.04 ml will be filled in patch chambers and will be occluded for 24 hours. Application will be done once Control Intervention1: S

Sponsors

Cipla Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Voluntary men and women Having apparently healthy skin on test area. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, saunaâ?¦), during the course of the study.

Exclusion criteria

Exclusion criteria: People who have a job involving water contact or a job which causes perspiration. (Routine work can be done. No carrying out activities like excessive /brisk walking, exercising etc). Pregnancy (by history) and lactating women. Scars, excessive terminal hair or tattoo on the studied area.

Design outcomes

Primary

MeasureTime frame
Evaluation of skin irritation reactions (erythema, oedema, dryness, scaling wrinkling), using Draize scaleTimepoint: 48 hours after patch application—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactMr Vinayak Marathe

Cipla Ltd.

Vinayak.Marathe@Cipla.com9930207772

Outcome results

None listed

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