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Epicutaneous Testing of Cosmetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03024671
Recruitment Status : Recruiting
First Posted : January 19, 2017
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
Mibelle AG
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief 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.

Condition or disease Intervention/treatment Phase
Dermatitis Other: Patch test application Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Epicutaneous Testing of Cosmetic Products to Determine Skin Compatibility
Actual Study Start Date : February 10, 2017
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

Arm Intervention/treatment
Experimental: patch test
Patients with patch test of cosmetics
Other: Patch test application
test patch with cosmetic product will be applied to the back




Primary Outcome Measures :
  1. Number of patients with positive patch test reactions to cosmetics [ Time Frame: 4 weeks ]
    Inflammation of Skin at test patch location



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024671


Contacts
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Contact: Dagmar Simon, MD +41 31 632 2278 dagmar.simon@insel.ch

Locations
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Switzerland
Inselspital Bern Recruiting
Bern, Switzerland
Contact: Dagmar Simon, MD    +41 31 632 2278    dagmar.simon@insel.ch   
Contact: Mark Wienand       studynurse.derma@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Mibelle AG
Investigators
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Principal Investigator: Dagmar Simon, MD Dept. of Dermatology, Inselspital

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03024671     History of Changes
Other Study ID Numbers: KEK-BE 2016-01686
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: single centered study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis
Skin Diseases