FindTrial
Sign In

To evaluate the safety of Primary Irritation Patch Test test product in healthy volunteers

â??Dermatological safety evaluation of test products by Primary Irritation Patch Test within 24 hours of application on healthy human all skin typesâ?¿.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048219
Enrollment
24
Registered
2022-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Vasu Health Care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects who are willing to participate in the study and sign the informed consent document and comply with the trial procedure. 2.Healthy Men & women volunteers are chosen in ratio of 1:1 aged > 35 and 3.Having healthy skin on test area as assessed by dermatological examination and donâ??t have history of allergy.

Exclusion criteria

Exclusion criteria: 1.Pregnant/nursing mothers. 2.Scars, excessive terminal hair, or tattoos on the studied area. 3.Dermatological infection/pathology on level of studied area. 4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material) 5.Chronic illness which may influence the outcome of the study.

Design outcomes

Primary

MeasureTime frame
2.1. Primary End Point: Number ofsubjects that showed no significant irritation. Score of less than or equal to 2 on the Draize scale. Timepoint: Baseline,Day1, Day 2, Day 3, Day 7—

Secondary

MeasureTime frame
NATimepoint: NA—

Countries

India

Contacts

Public ContactMeena Dalal

TrialGuna Private Limited

meena@trialguna.com9972636265

Outcome results

None listed

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