Irritant Contact Dermatitis Clinical Trial
Official title:
Prospective Single Center Randomized Double Blind Controlled Tolerability Trial of Six Hair Cleansing Conditioners
NCT number | NCT03483025 |
Other study ID # | A17-335 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 4, 2018 |
Est. completion date | December 14, 2018 |
Verified date | April 2018 |
Source | HealthPartners Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hair cleansing product tolerability study
Status | Completed |
Enrollment | 200 |
Est. completion date | December 14, 2018 |
Est. primary completion date | December 14, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria:• Age of 18 years or older - Signed and witnessed written informed consent - Willingness and ability to comply with the study protocol - For women of child-bearing potential, negative urine pregnancy test at enrollment Exclusion Criteria: - The presence of an overt bacterial, viral or fungal infection of the arms - The presence of any skin condition on the arms that, in the opinion of the investigator, could interfere with study assessments. - History of bullous skin disorders, psoriasis, ichthyosis, and/or any other chronic skin condition which could result in skin barrier dysfunction (other than atopic dermatitis). - Treatment with systemic immunosuppressive drugs within 2 weeks of enrollment. - Treatment with topical antibacterial, antimycotic, or immunosuppressive medications (including topical corticosteroids) on the forearms within 2 weeks of enrollment. - Use of over-the-counter moisturizers to the forearms in the 3 days prior to protocol commencement. - Menstruating females of childbearing potential who are not willing to use a medically accepted method of contraception, during the study and up to 4 weeks after the end of study. Medically approved contraception may, at the discretion of the investigator, include abstinence. - Women who are breastfeeding - Patients with a severe medical condition(s) which, in the view of the investigator, prohibits participation in the study - Use of any other investigational agent in the 30 days prior to study commencement - Known allergy to the study products or ingredients |
Country | Name | City | State |
---|---|---|---|
United States | Park Nicollet Contact Dermatitis Clinic | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
HealthPartners Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Repeat Open Application Test | intolerance will be defined as 1) ROAT skin component scoring >6 (of 10 maximum) or 2) ROAT global score of >4 (of 5 maximum). | 5 wks |
Status | Clinical Trial | Phase | |
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