Status:
COMPLETED
Prospective Single Center Randomized Double Blind Controlled Tolerability Trial of Six Hair Cleansing Conditioners
Lead Sponsor:
HealthPartners Institute
Conditions:
Irritant Contact Dermatitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Hair cleansing product tolerability study
Detailed Description
Study Aim: The objective of this study is to evaluate the tolerability of daily use of f hair cleansing products. Background/Study Rational/Significance: There have been consumer reports of irritancy...
Eligibility Criteria
Inclusion
- • 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
- 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
Key Trial Info
Start Date :
April 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2018
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03483025
Start Date
April 4 2018
End Date
December 14 2018
Last Update
February 25 2019
Active Locations (1)
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1
Park Nicollet Contact Dermatitis Clinic
Minneapolis, Minnesota, United States, 55450