NCT01992185

Photocil (Topical) for the Treatment of Vitiligo

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Applied Biology, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitiligo

Interventions

Type	Name	Description
DRUG	Photocil for Vitiligo	Photocil for Vitiligo
OTHER	Placebo - Sunscreen (SPF 2)	Placebo - Sunscreen (SPF 2)

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-11-25
• Last updated: 2016-03-10
• Results posted: 2016-03-10

Locations

1 site across 1 country: United States