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NCT03024671 Clinical Trial

Epicutaneous Testing of Cosmetics for Skin Compatibility

Dermatitis Clinical Trial

Official title:
Epicutaneous Testing of Cosmetic Products to Determine Skin Compatibility

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03024671
Other study ID # KEK-BE 2016-01686
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 10, 2017
Est. completion date December 2025

Study information
Verified date February 2023
Source University Hospital Inselspital, Berne
Contact Dagmar Simon, MD
Phone +41 31 632 2278
Email dagmar.simon@insel.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The dermatological testing of cosmetic products which are new on the market, or existing products with novel formulations is common and a useful procedure, yet necessary to alleviate common irritants and contact allergic reactions. Cosmetic products contain a range of substances that may be considered as potential irritants or contact allergens. In order to estimate that risk, cosmetics are tested by applying patch tests.

Description:

The dermatological testing of cosmetic products which are new on the market, or existing products with novel formulations is common and a useful procedure, yet necessary to alleviate common irritants and contact allergic reactions. Cosmetic products contain a range of substances that may be considered as potential irritants or contact allergens. In order to estimate that risk, cosmetics are tested by applying patch tests, as with allergic reactions.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Men and women older than 18 years old - Persons undergoing a diagnostic patch test for reason of a skin disease - Signed written informed consent Exclusion Criteria: - Acute skin inflammation and eczema on the back - Systemic corticosteroid and immunosuppressive therapy as well as UV exposure of the back within the last 4 weeks - Topical corticosteroids used on the back within the last two weeks

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Patch test application
test patch with cosmetic product will be applied to the back

Locations
Country Name City State
Switzerland Inselspital Bern Bern

Sponsors (2)
Lead Sponsor Collaborator
University Hospital Inselspital, Berne Mibelle AG

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with positive patch test reactions to cosmetics Inflammation of Skin at test patch location 4 weeks
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