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

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ClinicalTrials.gov Identifier: NCT03618992
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Arizona

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.

Condition or disease Intervention/treatment Phase
Valley Fever Coccidioidomycosis Other: Cholesterol-containing moisturizers Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Randomized control split body study
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improving the Appearance of Skin and Hair in Patients Undergoing Valley Fever Treatment
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
Active Comparator: Cohort 1
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
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).

No Intervention: Cohort 2
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.
No Intervention: Cohort 3
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.



Primary Outcome Measures :
  1. Skin barrier function - Transepidermal water loss (TEWL) [ Time Frame: 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.

  2. Skin barrier function - Stratum corneum hydration [ Time Frame: Up to one year ]
    Assess skin barrier function through measurement of stratum corneum hydration (in arbitrary units) using a commercially-available, non-invasive device.

  3. Skin barrier function - Sebum [ Time Frame: Up to one year ]
    Assess skin barrier function through measurement of sebum (in micrograms/cm^2) using a commercially-available, non-invasive device.

  4. Skin barrier function - pH [ Time Frame: 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 Outcome Measures:
  1. Hair characteristics [ Time Frame: Up to one year ]
    Evaluate caliber and density of scalp, eyebrow and eyelash hair through hair samples and photos.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618992


Contacts
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Contact: Aleksi Hendricks (520) 694-1828 aleksihendricks@email.arizona.edu

Locations
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United States, Arizona
Banner University Medical Group - Dermatology Recruiting
Tucson, Arizona, United States, 85718
Contact: Aleksi Hendricks       aleksihendricks@email.arizona.edu   
Principal Investigator: Vivian Shi, MD         
Banner Universtiy Medical Group - Valley Fever Clinic Recruiting
Tucson, Arizona, United States, 85719
Contact: Aleksi Hendricks       aleksihendricks@email.arizona.edu   
Principal Investigator: John Galgiani, MD         
Principal Investigator: Fariba Donovan, MD         
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Vivian Shi, MD University of Arizona

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03618992     History of Changes
Other Study ID Numbers: 1806645760
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Arizona:
Valley Fever
Coccidioidomycosis

Additional relevant MeSH terms:
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Fever
Coccidioidomycosis
Coccidiosis
Body Temperature Changes
Signs and Symptoms
Mycoses
Protozoan Infections
Parasitic Diseases