Psoriasis Clinical Trial
Official title:
Pilot Study of Novel Topical Drug (Photocil) for the Treatment of Psoriasis Vulgaris
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 psoriasis
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 Psoriasis Area Severity Index (PASI)-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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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