Clinical Trial Review

totally clear. Secondary outcome measures are a responder rate of the target toenail, defined as negative KOH microscopy, negative culture for dermatophytes, and ≤10% residual involvement of the target toenail. Overall safety will be gaged by recording any adverse event during the entire study duration and the local tolerability by means of severity scores for skin irritation. Inclusion criteria include male or female patients aged 12 years and older of any race with onychomycosis involving ≥ 20% to ≤ 50% of the target big toenail. Patients must have a positive KOH examination and culture positive for dermatophyte.

The study will draw patients from the Transplant Dermatology specialty clinic, where the investigators see organ transplant recipients for regular screening, and which serves as a regional referral center for this population. Enrollment will be limited to 20 patients. Inclusion criteria are organ transplant recipients’ status, active immunosuppression for at least 5 years, and history of at least one nonmelanoma skin cancer.

Patients will receive Levulan Kerastick (aminolevulinic acid) to the face and/or scalp (if both are needed, treated separately on back to back days); incubation of 2.5 hours; and blue light photodynamic therapy (PDT) using the DUSA Pharmaceuticals, Inc., BLU-U device administered quarterly for 3 years. Patients who change systemic immunosuppression regimens or add or increase systemic chemoprevention while in the study will be excluded from the overall analysis. The patients will be evaluated by the principal investigator every 3 months, prior to PDT administration.

Topical therapy with retinoids is the only proven medical therapy for aged/photoaged human skin. However, topical therapy with retinoids often results in unwanted cutaneous dermatitis, including erythema and scaling. The researchers intend to investigate the dose, frequency of use, and time dependence of topical retinol-induced dermatitis. They will evaluate retinoidinduced dermatitis biochemically, including retinol regulation of retinoid responsive genes that control retinoid metabolism and serve as markers for retinoid bioactivity. The researchers will also investigate the role of the epidermal growth factor receptor signaling pathway in retinoid-induced dermatitis.

Inclusion criteria include males and females of at least 21 years of age in good general health, with no disease states of medications that would impair evaluation of the test sites, no use of oral retinoids in the past year, no use of topical steroids in the past 2 weeks, and a willingness and ability to follow protocol.