Study Results
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View full resultsBasic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2013-08-31
2014-12-31
Brief Summary
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Detailed Description
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Many drawbacks limit patients compliance, access, and acceptance of traditional NB-UVB phototherapy. The strict treatment regimen (2-3 sessions per week for an average of 12 weeks or more) performed at a specialized phototherapy clinic combined with high cost and low or no reimbursement make compliance and access a major drawback.
In order to address the drawbacks of phototherapy, we developed a novel topical cream - Photocil - that selectively delivers NB-UVB therapy when exposed to sunlight. When used with natural sunlight, Photocil provides a convenient alternative to traditional clinic based phototherapy; thus, has the potential to dramatically increase patient compliance and treatment outcome.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Photocil for Vitiligo
Active Drug - Photocil for Vitiligo
Photocil for Vitiligo
Photocil for Vitiligo
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2)
Interventions
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Photocil for Vitiligo
Photocil for Vitiligo
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Vitiligo lesions affecting at a minimum 5% of the facial, legs, or arms surface area
* Age: 18 to 65
* Participants able to give informed consent
Exclusion Criteria
* Subject completed phototherapy for same lesion(s) in last 6 months
* Subject has previous history of skin cancer
* Subject has previous history of photosensitivity
* Subject has a history of herpes (HSV I or II) outbreaks
* Subject has previous history of autoimmune disease may be excluded at investigator's discretion
* Subject is currently taking of immunosuppressive or photosensitizing drugs
* Subject plans to use antibiotics, anti-fungal, calcineurin inhibitors or other drugs that may cause photosensitivity during the study period. These patients may be excluded at investigator's discretion
* Subject is pregnant or lactating women
18 Years
65 Years
ALL
No
Sponsors
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Applied Biology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John McCoy, PhD
Role: STUDY_DIRECTOR
Applied Biology, Inc.
Locations
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Physicians Institute
Tucson, Arizona, United States
Countries
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Other Identifiers
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AB-DRUG-PHOTOCIL-VT-001
Identifier Type: -
Identifier Source: org_study_id
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