Clinical trial NCT01992185: Photocil (Topical) for the Treatment of Vitiligo
Official title: Pilot Study of Novel Topical Drug (Photocil) for the Treatment of Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitiligo
Lead sponsor: Applied Biology, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Repigmentation
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Physicians Institute
state: Arizona
Study officials:
affiliation: Applied Biology, Inc.
name: John McCoy, PhD
role: STUDY_DIRECTOR
References: