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

NCT03618992 | Terminated

• 1 other identifier: 1806645760
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Valley Fever; Coccidioidomycosis

Keywords

Valley Fever; Coccidioidomycosis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Other Outcomes (1)

• Hair characteristics

  Up to one year

Study Arms (3)

Cohort 1

ACTIVE COMPARATOR

Subjects will be provided with containers of topical cholesterol-containing moisturizers to be applied to the skin and hair, identical except for labels designating left and right. Topical formulations will be purchased by Skin Actives Scientific (www.skinactives.com), and will consist of one container of intervention and one of vehicle only (see ingredients below), to be applied to the left or right arm as indicated by pre-randomization assignment. Patients will be instructed to begin a 1-week washout period in which they will stop all topicals, and will then begin daily application of the topical intervention products to the indicated sites. Patients will return for follow-up visits at 2, 6, 10, and 14 weeks after starting intervention.

Other: Cholesterol-containing moisturizers

Cohort 2

NO INTERVENTION

Pre-study randomization will assign patients to have measurements obtained from either the left or right side of the body. Baseline skin barrier measurements of the skin and lips will be obtained, including transepidermal water loss (TEWL), hydration, pH and sebum (oil). Photos of the skin, lips, eyebrows, eyelashes and scalp will be taken. On each side, samples of scalp (pluck 1), eyebrow (trim 1), and eyelash (trim 1) hairs will be obtained only at baseline and the final visit. Patients will return for follow-up visits at 1, 2, and 3 months after discontinuation of oral antifungal therapy.

Cohort 3

NO INTERVENTION

Pre-study randomization will assign patients to have measurements obtained from either the left or right side of the body. Baseline skin barrier measurements of the skin and lips will be obtained, including transepidermal water loss (TEWL), hydration, pH and sebum (oil). Photos of the skin, lips, eyebrows, eyelashes and scalp will be taken. On each side of the body, samples of scalp (pluck 1, trim 1), eyebrow (pluck 1, trim 1), and eyelash (trim 1) hairs will be obtained at the baseline and final visit. Patients will return for follow-up visits at monthly intervals after initiation of oral antifungal therapy for up to 12 months.

Interventions

Cholesterol-containing moisturizers OTHER

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).

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (2)

University of Arizona - Banner University Medicine Dermatology

Tucson, Arizona, 85718, United States

Location

Valley Fever Center for Excellence

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Coccidioidomycosis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Vivian Shi, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control split body study

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 7, 2018
• Study Start: August 1, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: June 4, 2021

Record last verified: 2021-06

Locations

US (2)