Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation (DERM EV TOPIC)
Study Overview
Status
Status
Conditions
Conditions
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 18 to 70 years old;
- Skin types: I (light caucasian), II (caucasian), III (light dark) and IV (dark)
- intact skin where the product will be applied
- Agreement to comply with the test procedures and attend the clinic in the days and ixed times for medical assessments and application and reading of dressings
- Signature of informed consent form
Exclusion Criteria:
- Pregnancy and lactation
- Use of anti-inflammatory and immunosuppressive drugs from 30 days up to three months prior to selection;
- Diseases that cause immune suppression;
- Personal history of atopy;
- History of sensitisation and irritability to topical products;
- Active cutaneous pathologies (local and / or scattered) that may interfere in the study results;
- Use of new drugs and/or cosmetics during the experiment;
- Skin reactivity;
- Previous participation in a study with the same product under test;
- Volunteers who have congenital or acquired known immunodeficiency;
- Relevant medical history or current evidence of alcohol or other drugs abuse;
- Known historical or suspected intolerance to any ingredient of the product under study (product under test or comparator);
- Sponsor's employees involved in the study, or close family member of an employee involved in the study;
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluation of adverse effects in maximized conditions
Time Frame: 60 days
|
60 days
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- Kley Hertz 005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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