Vitiligo
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 vitiligo.
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 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.
Interventions
DRUGPhotocil for Vitiligo
Photocil for Vitiligo
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 vitiligo confirmed by a dermatologist * 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 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 Repigmentation | 90 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Photocil for Vitiligo Active Drug - Photocil for Vitiligo
Photocil for Vitiligo: Photocil for Vitiligo | 7 |
| Placebo - Sunscreen (SPF 2) Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2) | 8 |
| Total | 15 |
Baseline characteristics
| Characteristic | Photocil for Vitiligo | Placebo - Sunscreen (SPF 2) | Total |
|---|---|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 13.4 | 35.1 years STANDARD_DEVIATION 15.2 | 36.5 years STANDARD_DEVIATION 13.9 |
| Region of Enrollment United States | 7 participants | 8 participants | 15 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 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 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 |
Outcome results
Primary
Percent Repigmentation
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Photocil for Vitiligo | Percent Repigmentation | 48.5 Percent Repigmentation | Standard Deviation 16.8 |
| Placebo - Sunscreen (SPF 2) | Percent Repigmentation | 2.5 Percent Repigmentation | Standard Deviation 7.1 |