Clinical trial NCT03618992: Improving the Appearance of Skin and Hair in Patients Undergoing Valley Fever Treatment
Official title: Improving the Appearance of Skin and Hair in Patients Undergoing Valley Fever Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Valley Fever
Coccidioidomycosis
Keywords: Valley Fever
Coccidioidomycosis
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized control split body study
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Skin barrier function - Transepidermal water loss (TEWL)
timeFrame: Up to one year
measure: Skin barrier function - Stratum corneum hydration
timeFrame: Up to one year
measure: Skin barrier function - Sebum
timeFrame: Up to one year
measure: Skin barrier function - pH
timeFrame: Up to one year
Secondary outcomes:
Other outcomes:
measure: Hair characteristics
timeFrame: Up to one year
Locations:
city: Tucson
country: United States
facility: University of Arizona - Banner University Medicine Dermatology
state: Arizona
city: Tucson
country: United States
facility: Valley Fever Center for Excellence
state: Arizona
Study officials:
affiliation: University of Arizona
name: Vivian Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: