Skin Irritability Clinical Trial
— DERM EV TOPICOfficial title:
Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation
Verified date | December 2016 |
Source | Kley Hertz S/A |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Brasilian Health Surveillance Agency |
Study type | Observational |
Check the safety under normal conditions of use through the verification of emergence signs of irritability and sensitisation of the genital mucosa.
Status | Not yet recruiting |
Enrollment | 55 |
Est. completion date | |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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; |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kley Hertz S/A |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of adverse effects in maximized conditions | 60 days | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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