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

NCT03483025 | Completed

• 1 other identifier: A17-335
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Hair cleansing product tolerability study

Conditions

Irritant Contact Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

Hair Cleansing product 1

OTHER

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

Hair cleansing product 2

OTHER

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

Hair cleansing product 3

OTHER

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

Hair cleansing product 4

OTHER

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

Hair cleansing product 5

OTHER

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

Hair cleansing product 6

OTHER

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

Interventions

Skin Testing of Hair cleansing products OTHER

6 different commercially available shampoos

Hair Cleansing product 1; Hair cleansing product 2; Hair cleansing product 3; Hair cleansing product 4; Hair cleansing product 5; Hair cleansing product 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Park Nicollet Contact Dermatitis Clinic

Minneapolis, Minnesota, 55450, United States

Location

Related Publications (1)

• 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.

  PMID: 32122177 DERIVED

MeSH Terms

Conditions

Dermatitis, Irritant

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• erin warshaw, MD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, controlled

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 29, 2018
• Study Start: April 4, 2018
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: February 25, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)