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Evaluation of Skin Safety of a Nano Urea emulsion Through 24-Hour Patch Testing in Healthy Individuals.

Evaluation of Dermatological Safety of an Investigational Urea Nano-Emulsion Product Through a 24-Hour Occlusive Patch Test on Healthy Human Subjects. - CROM/11

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/11/077114
Enrollment
60
Registered
2024-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

CROM Clinical Research and Medical Tourism Pvt. Ltd. Division Nano Agro Technologies
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects in age group 18 - 55 years (both the ages inclusive). Healthy male subjects. Subjects with Fitzpatrick skin type III to V. Subjects willing to give a written informed consent. Subjects willing to maintain the patch test in position for 24 hours. Subject having not participated in a similar investigation in the past one month. Subjects willing to come for regular follow up visits. Subjects ready to follow instructions during the study period.

Exclusion criteria

Exclusion criteria: Infection, allergy on the tested area. Skin allergy, antecedents or atopic subjects. Athletes and subjects with history of excessive sweating. Cutaneous disease which may influence the study result. Subjects on oral corticosteroid . Subjects participating in any other cosmetic or therapeutic study. Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

Design outcomes

Primary

MeasureTime frame
Safety on dermal patch tests for all the productsTimepoint: 0 hrs, 24 hrs and and 7 days

Secondary

MeasureTime frame
NoneTimepoint: None

Countries

India

Contacts

Public ContactDr Dhananjay Lad

CROM Nano Technologies Pvt Ltd

cromnanotechnologies@gmail.com9158592177

Outcome results

None listed

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