Psoriasis
Conditions
Brief summary
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 psoriasis
Detailed description
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 Psoriasis Area Severity Index (PASI)-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.
Interventions
DRUGPhotocil for Psoriasis
Photocil for Psoriasis
Placebo - Sunscreen (SPF 2)
Sponsors
Applied Biology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with psoriasis vulgaris confirmed by a dermatologist * Psoriasis 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 did not respond to prior phototherapy treatment * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Lesion Clearance | 90 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Photocil for Psoriasis Active Drug - Photocil for Psoriasis
Photocil for Psoriasis: Photocil for Psoriasis | 7 |
| Placebo - Sunscreen (SPF 2) Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2) | 5 |
| Total | 12 |
Baseline characteristics
| Characteristic | Photocil for Psoriasis | Placebo - Sunscreen (SPF 2) | Total |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 9.7 | 35 years STANDARD_DEVIATION 14 | 41 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 7 participants | 5 participants | 12 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 5 |
| serious Total, serious adverse events | 0 / 7 | 0 / 5 |
Outcome results
Primary
Percent Lesion Clearance
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Photocil for Psoriasis | Percent Lesion Clearance | 75.7 Percent Clearance | Standard Deviation 23.7 |
| Placebo - Sunscreen (SPF 2) | Percent Lesion Clearance | 8 Percent Clearance | Standard Deviation 8.3 |