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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 atopic dermatitis.
NB-UVB phototherapy is a common treatment for patients with atopic dermatitis, and has been reported to be safe and effective in numerous clinical trials. Clinical trials have reported achievement of Atopic Dermatitis Area Severity Index (ADASI)-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 Atopic Dermatitis | Active Comparator | Active Drug - Photocil for Atopic Dermatitis |
|
| Placebo - Sunscreen (SPF 2) | Placebo Comparator | Placebo - Sunscreen (SPF 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photocil for Atopic Dermatitis | Drug | Photocil for Atopic Dermatitis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Pruritus Events in Last 30 Days | 30 days from baseline |
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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 Atopic Dermatitis | Active Drug - Photocil for Atopic Dermatitis Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis |
| 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 Atopic Dermatitis | Active Drug - Photocil for Atopic Dermatitis Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis |
| BG001 | 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, Categorical | Number |
| 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 | Number of Pruritus Events in Last 30 Days | Posted | Mean | Standard Deviation | Events | 30 days from baseline |
|
|
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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 Atopic Dermatitis | Active Drug - Photocil for Atopic Dermatitis Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis |
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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 |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Placebo - Sunscreen (SPF 2) | Other | Placebo - Sunscreen (SPF 2) |
|
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Gender | Number | 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 | 0 | 0 | 0 |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |