Improving the Appearance of Skin and Hair in Patients Undergoing Valley Fever Treatment

Coccidioidomycosis Clinical Trial

Official title:

Improving the Appearance of Skin and Hair in Patients Undergoing Valley Fever Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03618992
• Other study ID #: 1806645760
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: June 2021
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a multi-visit study that will take approximately 3 hours in total. Up to 200 subjects from the BUMC Valley Fever and BUMC Dermatology clinics will be enrolled in this study and assigned to one of three cohorts according to timeline of oral anti-fungal therapy. Subjects in Cohort 1 will be randomized to apply topical cholesterol-containing moisturizers to the skin, hair and lips on either the right or left side of the body daily. Measurements of skin barrier function, appearance of skin and hair, and hair samples will be obtained at baseline and at 4 week follow-up visits. Cohorts 2 and 3 will be observational groups at differing points in oral antifungal treatment regimen. Subjects will be randomized to have measurements of skin barrier function and hair and skin characteristics obtained from either the right or left side of the body at baseline and at monthly follow-up visits.

Description:

Coccidioidomycosis, also known as Valley Fever, is a fungal condition most commonly seen in Arizona and can affect multiple organs, including the skin, lung, bone, joints, and central nervous system. Oral antifungal therapy such as fluconazole is the first-line medication to treat coccidioidomycosis. Through the investigator's clinical observations at the Valley Fever Center for Excellence, nearly all patients who have been placed on systemic azole treatment show some extent of cosmetic changes in their skin and hair, such as dry skin, chapped lips, hair loss, and change in hair characteristics. The goals of the study are to 1) understand the cosmetic changes in the skin and hair in patients initiating and discontinuing long-term oral antifungals, and 2) to examine whether cholesterol-based commercially-available moisturizers for the skin and for the hair can improve the cosmetic appearance better than a vehicle without these cholesterol ingredients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women, age 18 or older
• Patients who have been diagnosed with coccidioidomycosis (valley fever) requiring oral anti-fungal medications such as but not limited to fluconazoles
• Able to comprehend and read the English language

Exclusion Criteria:

• Subject does not fit inclusion criteria
• Children younger than 18 years of age
• Pregnant women
• Prisoners or those that are cognitively impaired
• Those with known allergies or intolerance to ingredients in the topical formulations
• Subject is unwilling or unable to comply with study procedures
• Unable to read or comprehend English

Related Conditions & MeSH terms

• Coccidioidomycosis
• Fever
• Valley Fever

Intervention

Other:
• Cholesterol-containing moisturizers
Commercially-available cholesterol containing topical formulations to be applied daily to the scalp, skin, lips, eyelashes, and eyebrows. Available from Skin Actives Scientific (www.skinactives.com).

Locations

Country	Name	City	State
United States	University of Arizona - Banner University Medicine Dermatology	Tucson	Arizona
United States	Valley Fever Center for Excellence	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hair characteristics	Evaluate caliber and density of scalp, eyebrow and eyelash hair through hair samples and photos.	Up to one year
Primary	Skin barrier function - Transepidermal water loss (TEWL)	Assess skin barrier function through measurement of transepidermal water loss (in g/m^2h) using a commercially-available, non-invasive device.	Up to one year
Primary	Skin barrier function - Stratum corneum hydration	Assess skin barrier function through measurement of stratum corneum hydration (in arbitrary units) using a commercially-available, non-invasive device.	Up to one year
Primary	Skin barrier function - Sebum	Assess skin barrier function through measurement of sebum (in micrograms/cm^2) using a commercially-available, non-invasive device.	Up to one year
Primary	Skin barrier function - pH	Assess skin barrier function through measurement of stratum corneum pH (in pH units) using a commercially-available, non-invasive device.	Up to one year