Photocil (Topical) for the Treatment of Vitiligo

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.

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