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Safety evaluation of test products on healthy human skin types

Dermatological safety evaluation of test products by Primary Irritation Patch Test within 24 hours of apply on healthy human all skin types.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050684
Enrollment
24
Registered
2023-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

KK organic
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Voluntary men and women ration of 1:1 between 18 and 65 years. 2.Having healthy skin on test area as assessed by dermatological examination. 3.For whom the investigator considers that the compliance will be correct. 4.Subjects with normal, dry, oily and combination skin

Exclusion criteria

Exclusion criteria: 1.Pregnant/nursing mothers. 2.Scars, excessive terminal hair, or tattoo on the studied area. 3.Dermatological infection/pathology on level of studied area. 4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material) 5.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.

Design outcomes

Primary

MeasureTime frame
Number of subjects that showed No significant irritation. Score of less than or equal to 2 on the Draize scale. Timepoint: Day 1, Day 2, Day 3, Day 8—

Secondary

MeasureTime frame
NATimepoint: NA—

Countries

India

Contacts

Public ContactMeena Dalal

Trial Guna Pvt Ltd

drsohanshetty@yahoo.co.in8867125414

Outcome results

None listed

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