- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03007498
Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation (DERM EV TOPIC)
December 29, 2016 updated by: Kley Hertz S/A
Check the safety under normal conditions of use through the verification of emergence signs of irritability and sensitisation of the genital mucosa.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
55
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with age from 18 to 70 years old, with skin color varying between clear caucasian to dark.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of adverse effects in maximized conditions
Time Frame: 60 days
|
60 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2017
Primary Completion (ANTICIPATED)
February 1, 2017
Study Registration Dates
First Submitted
December 29, 2016
First Submitted That Met QC Criteria
December 29, 2016
First Posted (ESTIMATE)
January 2, 2017
Study Record Updates
Last Update Posted (ESTIMATE)
January 2, 2017
Last Update Submitted That Met QC Criteria
December 29, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
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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