Epicutaneous Testing of Cosmetics for Skin Compatibility

NCT ID: NCT03024671

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-10

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patch test

Patients with patch test of cosmetics

Group Type EXPERIMENTAL

Patch test application

Intervention Type OTHER

test patch with cosmetic product will be applied to the back

Interventions

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Patch test application

test patch with cosmetic product will be applied to the back

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mibelle AG

INDUSTRY

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dagmar Simon, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Dermatology, Inselspital

Locations

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Inselspital Bern

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Dagmar Simon, MD

Role: CONTACT

+41 31 632 2278

Facility Contacts

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Dagmar Simon, MD

Role: primary

+41 31 632 2278

Mark Wienand

Role: backup

Other Identifiers

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KEK-BE 2016-01686

Identifier Type: -

Identifier Source: org_study_id

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