Prospective Single Center Randomized Double Blind Controlled Tolerability Trial of Six Hair Cleansing Conditioners

Hair cleansing product tolerability study

Study Overview

• Status: Completed
• Conditions: Irritant Contact Dermatitis
• Intervention / Treatment: Other: Skin Testing of Hair cleansing products

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 and hair loss with use of Wen cleansing conditioner. A recent study of 142 patients found no increase in hair loss when used in normal subjects, however skin assessments for tolerability were not evaluated.

Methodology: This double-blind, randomized, controlled clinical trial will evaluate the tolerability of six hair cleansing products including Wen cleansing conditioner using two standard clinical and research methods, Repeat Open Application Tests (ROAT) (a test for irritancy) and Semi-Open Patch Tests (a test for allergenicity). For the ROAT, participants will apply the hair cleansing products to 6 separate locations on the forearm using a standardized, protocol and scored using a 10-point scale. Application site of each cleansing product will be randomized. Exposure time will be increased in a step-wise fashion over 5 weeks. Participants and investigators will be blinded to location of products. The primary outcome is intolerance; intolerance will be defined as 1) ROAT skin component scoring >6 (of 10 maximum) or 2) ROAT global score of >4 (of 5 maximum). If intolerance to a specific product is reached, the ROAT for that product will be discontinued. . Clinical assessments (global scoring and component scoring) will be performed at 0, 2, and 4 and 5 weeks. Primary outcomes will be measured at 5 weeks. Allergenicity is a secondary outcome and will be assessed with semi-open patch tests to the 6 hair cleansing products performed at week 4 and read at week 5

Setting/ patients: Single center study of 200 patients. To represent a broad spectrum of skin barrier function, recruitment will target enrollment of 150 individuals with a no history of childhood eczema (non-atopic) and 50 individuals with a history of childhood eczema (atopic).

Population: Men and women over the age of 18 years old.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55450
      • Park Nicollet Contact Dermatitis Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hair Cleansing product 1; Skin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded	Other: Skin Testing of Hair cleansing products; 6 different commercially available shampoos
Other: Hair cleansing product 2; Skin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded	Other: Skin Testing of Hair cleansing products; 6 different commercially available shampoos
Other: Hair cleansing product 3; Skin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded	Other: Skin Testing of Hair cleansing products; 6 different commercially available shampoos
Other: Hair cleansing product 4; Skin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded	Other: Skin Testing of Hair cleansing products; 6 different commercially available shampoos
Other: Hair cleansing product 5; Skin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded	Other: Skin Testing of Hair cleansing products; 6 different commercially available shampoos
Other: Hair cleansing product 6; Skin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded	Other: Skin Testing of Hair cleansing products; 6 different commercially available shampoos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Investigators: Principal Investigator: erin warshaw, MD, HealthPartners Institute

Publications and helpful links

General Publications

• Warshaw EM, Schlarbaum JP, Liou YL, Kimyon RS, Zhang AJ, Nikle AB, Monnot AD, Hylwa SA. Tolerability of hair cleansing conditioners: a double-blind randomized, controlled trial designed to evaluate consumer complaints to the U.S. Food and Drug Administration. Cutan Ocul Toxicol. 2020 Jun;39(2):89-96. doi: 10.1080/15569527.2020.1722154. Epub 2020 Mar 2.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): December 14, 2018
• Study Completion (Actual): December 14, 2018

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Contact; Dermatitis, Irritant
• Other Study ID Numbers: A17-335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No