Coccidioidomycosis, Valley Fever
Conditions
Keywords
Valley Fever, Coccidioidomycosis
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.
Interventions
OTHERCholesterol-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).
Sponsors
University of Arizona
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized control split body study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin barrier function - Transepidermal water loss (TEWL) | Up to one year | Assess skin barrier function through measurement of transepidermal water loss (in g/m\^2h) using a commercially-available, non-invasive device. |
| Skin barrier function - Stratum corneum hydration | Up to one year | Assess skin barrier function through measurement of stratum corneum hydration (in arbitrary units) using a commercially-available, non-invasive device. |
| Skin barrier function - Sebum | Up to one year | Assess skin barrier function through measurement of sebum (in micrograms/cm\^2) using a commercially-available, non-invasive device. |
| Skin barrier function - pH | Up to one year | Assess skin barrier function through measurement of stratum corneum pH (in pH units) using a commercially-available, non-invasive device. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hair characteristics | Up to one year | Evaluate caliber and density of scalp, eyebrow and eyelash hair through hair samples and photos. |
Countries
United States
Outcome results
None listed