DermatitisNCT03024671
Epicutaneous Testing of Cosmetics for Skin Compatibility
A study testing Patch test application in people with Dermatitis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis
- What is being tested?
- Patch test application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Feb 2017to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women older than 18 years old
- Persons undergoing a diagnostic patch test for reason of a skin disease
- Signed written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital Bern
Bern
Dagmar Simon, MD, +41 31 632 2278, dagmar.simon@insel.ch
Mark Wienand, studynurse.derma@insel.ch
About this study
Official title: Epicutaneous Testing of Cosmetic Products to Determine Skin Compatibility
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.
Read the 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.
- Conditions
- Dermatitis
- Being tested
- Patch test application
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patch test applicationOther
test patch with cosmetic product will be applied to the back
| Study group | Role | What they receive |
|---|---|---|
| patch test | Experimental | Patients with patch test of cosmetics Receives: Other: Patch test application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with positive patch test reactions to cosmetics
Inflammation of Skin at test patch location
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start10 Feb 2017
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatitisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Mibelle AG
- Responsible party
- Sponsor
- Investigators
- Dagmar Simon, MD, Principal investigator, Dept. of Dermatology, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024671
- Sponsor's protocol ID
- KEK-BE 2016-01686
- Status last verified
- Nov 2024
- First submitted
- 11 Jan 2017
- Last updated
- 19 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: single centered study
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicutaneous Testing of Cosmetic Products to Determine Skin Compatibility
- ClinicalTrials.gov ID
- NCT03024671
- Acronym / sponsor ID
- KEK-BE 2016-01686
- Conditions
- Dermatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Mibelle AG
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patch test | Experimental | Other: Patch test applicationPatients with patch test of cosmetics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women older than 18 years old
- Persons undergoing a diagnostic patch test for reason of a skin disease
- Signed written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patch test applicationtest patch with cosmetic product will be applied to the back | Other | patch test |
Primary outcome
Number of patients with positive patch test reactions to cosmetics
Time frame: 4 weeks
Inflammation of Skin at test patch location
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No. single centered study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dagmar Simon, MD principal investigator
Dept. of Dermatology, Inselspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patch test application in people with Dermatitis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dagmar Simon, MD (+41 31 632 2278, dagmar.simon@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with positive patch test reactions to cosmetics (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.