Clinical Trials Logo

Clinical Trial Summary

Hair cleansing product tolerability study


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03483025
Study type Interventional
Source HealthPartners Institute
Contact
Status Completed
Phase N/A
Start date April 4, 2018
Completion date December 14, 2018

See also
  Status Clinical Trial Phase
Completed NCT02996357 - Risk Factors for Incontinence-Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence N/A
Completed NCT03685929 - Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis
Terminated NCT04793711 - EpiCeram for Skin Protection in Healthcare Workers N/A
Completed NCT03231813 - Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery N/A