NCT03618992

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Valley Fever
• Coccidioidomycosis

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2018-08-01
• Primary completion: 2020-05-31
• Completion: 2020-05-31
• First posted: 2018-08-07
• Last updated: 2021-06-04

Locations

2 sites across 1 country: United States