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To evaluate safety of test product for skin irritation over a period of 14 days.

Evaluation of skin irritancy of a test product when applied on skin, using a 14-day human cumulative irritancy patch test

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/08/015251
Enrollment
36
Registered
2018-08-09
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: Saniscrub M: 0.2 ml will be applied, allowed to dry and occluded for 48 hours. This will be repeated 6 times on alternate days. Control Intervention1: 0.9% isotonic solution of saline:

Sponsors

Sirmaxo Chemicals Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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. Ready to wear loose cotton clothes

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
Scoring the reactions on skin. Superficial textural changes.Timepoint: Visit 2 - Visit 7—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactChitra Dhamankar

Sirmaxo Chemicals Pvt. Ltd.

chitra@sirmaxochem.in02242500821

Outcome results

None listed

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