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To evaluate safety of 1 test product for skin irritation.

Primary Irritation Patch Test as per BIS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/08/015546
Enrollment
35
Registered
2018-08-30
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: PEE SAFE SPRAY: 0.04 ml will be filled and occluded for 24 hours Control Intervention1: 3% SLS: 0.04 ml will be filled and occluded for 24 hours

Sponsors

Redcliffe Hygiene Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Voluntary men and/or 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
To evaluate the cutaneous tolerance by dermatological scoring of skin reactions using Draize scale.Timepoint: 48 hours—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactMr Vimal Bhola

Pontika Aerotech Limited

vimal.bhola@pontikaaerotech.com09805515020

Outcome results

None listed

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