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

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ClinicalTrials.gov Identifier: NCT03483025
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute

Brief Summary:
Hair cleansing product tolerability study

Condition or disease Intervention/treatment Phase
Irritant Contact Dermatitis Other: Skin Testing of Hair cleansing products Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: randomized, double-blind, controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The six hair cleansing products will be packaged in identical 1 ml capped tuberculin syringes (with no needles) and provided to participants. Each syringe will be labeled with the forearm location for application. Identical syringes containing the six hair cleansing products will be dispensed. Treatment site allocation will be determined by a computer-generated randomization log.
Primary Purpose: Other
Official Title: Prospective Single Center Randomized Double Blind Controlled Tolerability Trial of Six Hair Cleansing Conditioners
Actual Study Start Date : April 4, 2018
Estimated Primary Completion Date : April 4, 2019
Estimated Study Completion Date : June 4, 2019

Arm Intervention/treatment
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

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

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

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

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

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




Primary Outcome Measures :
  1. Repeat Open Application Test [ Time Frame: 5 wks ]
    intolerance will be defined as 1) ROAT skin component scoring >6 (of 10 maximum) or 2) ROAT global score of >4 (of 5 maximum).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483025


Contacts
Contact: erin warshaw, MD 952-977-3450 erin.warshaw@parknicollet.com
Contact: Maureen E Busch 612-341-1955 Maureen.E.Busch@healthpartners.com

Locations
United States, Minnesota
Park Nicollet Contact Dermatitis Clinic Recruiting
Minneapolis, Minnesota, United States, 55450
Contact: erin warshaw, md    952-977-3450    erin.warshaw@parknicollet.com   
Sponsors and Collaborators
HealthPartners Institute
Investigators
Principal Investigator: erin warshaw, MD HealthPartners Institute

Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT03483025     History of Changes
Other Study ID Numbers: A17-335
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Contact
Dermatitis, Irritant
Skin Diseases
Skin Diseases, Eczematous