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Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the safety and efficacy of Photocil in the treatment of vitiligo.
NB-UVB phototherapy is a common treatment for patients with psoriasis, and has been reported to be safe and effective in numerous clinical trials. Clinical trials have reported achievement of Vitiligo Area Severity Index (VASI)-75 in 50-70% of patients after 4-6 weeks of NB-UVB treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photocil for Vitiligo | Active Comparator | Active Drug - Photocil for Vitiligo |
|
| Placebo - Sunscreen (SPF 2) | Placebo Comparator | Placebo - Sunscreen (SPF 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photocil for Vitiligo | Drug | Photocil for Vitiligo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Repigmentation | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McCoy, PhD | Applied Biology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Institute | Tucson | Arizona | 85719 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Photocil for Vitiligo | Active Drug - Photocil for Vitiligo Photocil for Vitiligo: Photocil for Vitiligo |
| FG001 | Placebo - Sunscreen (SPF 2) | Placebo - Sunscreen (SPF 2) Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Photocil for Vitiligo | Active Drug - Photocil for Vitiligo Photocil for Vitiligo: Photocil for Vitiligo |
| BG001 | Placebo - Sunscreen (SPF 2) | Placebo - Sunscreen (SPF 2) Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Repigmentation | Posted | Mean | Standard Deviation | Percent Repigmentation | 90 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Photocil for Vitiligo | Active Drug - Photocil for Vitiligo Photocil for Vitiligo: Photocil for Vitiligo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Keene, MD | Physicians Institute | (520) 290-5555 | monican@appliedbiology.com |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo - Sunscreen (SPF 2) | Other | Placebo - Sunscreen (SPF 2) |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Placebo - Sunscreen (SPF 2) | Placebo - Sunscreen (SPF 2) Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2) | 0 | 8 | 0 | 8 |
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