Clinical Trial Review

Narrow Band Ultraviolet B (NB-UVB) phototherapy is a common treatment for patients with psoriasis, and has been reported to be safe and effective in numerous clinical trials. Photocil is a topical drug (cream) that selectively delivers NB-UVB therapy when exposed to sunlight. Photocil is intended to help protect users from non-therapeutic UVB radiation while selectively passing wavelengths of light in the NB-UVB range with peak transmission of 308 nm. The aim of the study is to assess the safety and efficacy of Photocil in the treatment of vitiligo.

The strict treatment regimen of traditional NB-UVB phototherapy – 2 to 3 sessions per week for an average of 12 weeks or more, performed at a specialized phototherapy clinic, combined with high cost and little to no reimbursement – make compliance and access a major drawback.

In order to address these drawbacks of traditional 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, and therefore has the potential to dramatically increase patient compliance and treatment outcome.

Alopecia areata is a common form of hair loss that reportedly occurs in up to 1.7% of the population at some time in their life. It is apparently triggered when the individual's own immune system attacks hair follicles on the scalp or body, resulting in hair loss ranging from single patches on the scalp (patch type alopecia areata) to loss of every hair on the scalp and body (alopecia universalis). Currently, there are limited treatment options for alopecia areata and, unfortunately, the treatments used have never been rigorously tested in a placebo-controlled trial.

Triamcinolone (kenalog) is a steroid solution that has been used as treatment for alopecia areata for over 50 years. It is administered via injection into the scalp and appears to have some efficacy for patients with mild to moderate alopecia areata. We currently do not have objective data on the frequency of occurrence of successful regrowth, the duration of response, or the incidence of side effects. In addition, there is disagreement between clinicians regarding the dose of intralesional triamcinolone (IL TAC) that is considered most effective.

This study aims to determine the frequency of response to treatment with 3 concentrations of IL TAC: 2.5 mg/mL, 5 mg/mL, or 10 mg/mL; as well as the duration of response and incidence of side effects compared with treatment with placebo (sterile saline solution).

This is a single-center, investigator-initiated, double-blinded, randomized, bilateral-comparison pilot study of injectable calcium hydroxylapatite with and without triamcinolone acetate for the treatment of volume loss to the dorsum areas of the hands. The primary analyses of efficacy will be based on the change from baseline through day 360 for assessment (based on the Merz Validated Hand Grading Score).