Photocil (Topical) for the Treatment of Vitiligo

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study of Novel Topical Drug (Photocil) for the Treatment of Vitiligo

Conditions
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Vitiligo

Intervention / Treatment
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* Drug: Photocil for Vitiligo
* Other: Placebo - Sunscreen (SPF 2)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Photocil for Vitiligo<br>Active Drug - Photocil for Vitiligo | Drug: Photocil for Vitiligo<br>* Photocil for Vitiligo<br>* Other names: Photocil for Vitiligo (U.S. FDA NDC: 54841-001-01);|
| Placebo Comparator: Placebo - Sunscreen (SPF 2)<br>Placebo - Sunscreen (SPF 2) | Other: Placebo - Sunscreen (SPF 2)<br>* Placebo - Sunscreen (SPF 2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Repigmentation |  | 90 days |