Back to resultsImproving the Appearance of Skin and Hair in Patients Undergoing Valley Fever Treatment
Primary Purpose
Valley Fever, Coccidioidomycosis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cholesterol-containing moisturizers
Sponsored by
About this trial
This is an interventional treatment trial for Valley Fever focused on measuring Valley Fever, Coccidioidomycosis
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
Sites / Locations
- University of Arizona - Banner University Medicine Dermatology
- Valley Fever Center for Excellence
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
No Intervention
No Intervention
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Skin barrier function - Sebum
Assess skin barrier function through measurement of sebum (in micrograms/cm^2) using a commercially-available, non-invasive device.
Skin barrier function - pH
Assess skin barrier function through measurement of stratum corneum pH (in pH units) using a commercially-available, non-invasive device.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03618992
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Investigator left university
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valley Fever, Coccidioidomycosis
Keywords
Valley Fever, Coccidioidomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Randomized control split body study
Masking
Participant
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cohort 2
Arm Type
No Intervention
Arm Description
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.
Arm Title
Cohort 3
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cholesterol-containing moisturizers
Intervention Description
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).
Primary Outcome Measure Information:
Title
Skin barrier function - Transepidermal water loss (TEWL)
Description
Assess skin barrier function through measurement of transepidermal water loss (in g/m^2h) using a commercially-available, non-invasive device.
Time Frame
Up to one year
Title
Skin barrier function - Stratum corneum hydration
Description
Assess skin barrier function through measurement of stratum corneum hydration (in arbitrary units) using a commercially-available, non-invasive device.
Time Frame
Up to one year
Title
Skin barrier function - Sebum
Description
Assess skin barrier function through measurement of sebum (in micrograms/cm^2) using a commercially-available, non-invasive device.
Time Frame
Up to one year
Title
Skin barrier function - pH
Description
Assess skin barrier function through measurement of stratum corneum pH (in pH units) using a commercially-available, non-invasive device.
Time Frame
Up to one year
Other Pre-specified Outcome Measures:
Title
Hair characteristics
Description
Evaluate caliber and density of scalp, eyebrow and eyelash hair through hair samples and photos.
Time Frame
Up to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian Shi, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona - Banner University Medicine Dermatology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
Valley Fever Center for Excellence
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Improving the Appearance of Skin and Hair in Patients Undergoing Valley Fever Treatment
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