A phase II multicenter clinical trial of systemic bexarotene in psoriasis.

BACKGROUND: Bexarotene, a novel and unique synthetic P, RXR-selective retinoid, is available as a treatment for cutaneous T-cell lymphoma. In psoriasis, a common retinoid-sensitive disease, no data are available on bexarotene treatment. OBJECTIVE: In this phase II study we investigated the safety, tolerability, and effectiveness of bexarotene in psoriasis at doses of 0.5 to 3.0 mg/kg/day. METHODS: Fifty patients with moderate to severe plaque-type psoriasis were treated with bexarotene in 4 sequential dose-defined panels of 12-13 patients at doses of 1.0, 2.0, 0.5, and 3.0 mg/kg/day for 12-24 weeks. Patients were monitored for safety and clinical efficacy. RESULTS: No serious adverse events related to the drug occurred. Bexarotene was well tolerated in most patients. Most frequently observed adverse events related to bexarotene were hypertriglyceridaemia (56%) and a decrease in free T4 serum levels (54%). Significant improvement of psoriasis after bexarotene at all doses was confirmed by a modified psoriasis area and severity index (mPASI), plaque elevation (PEL), and physician's global assessment (PGA). Overall response rates (> or =50% improvement) for mPASI, PEL, and PGA were 22%, 52%, and 36%, respectively. No significant dose-response effect was established for these parameters. CONCLUSION: The present study indicates an anti-psoriatic effect of bexarotene. Further studies are necessary to assess the optimal dose and the potential for bexarotene as a new therapy for psoriasis.

Curettage of giant congenital melanocytic nevi in neonates: a decade later.

BACKGROUND: Currently, there is tremendous uncertainty regarding how giant congenital melanocytic nevi (GCMN) should be treated. Our approach to patients with GCMN is based on 2 main considerations: (1) obtain an acceptable cosmetic result to decrease the psychosocial inconvenience to the patient, and (2) attempt to minimize the risk of malignancy. For the past 10 years we have treated GCMN by curettage in the neonatal period. We report our experience and results. OBSERVATIONS: Sixteen neonates with GCMN were treated by curettage between 1990 and 2000. Biopsy specimens were obtained and the patients received close clinical follow-up. In most patients cosmetic and functional results were good, and, to date, no melanoma has been observed in this series. CONCLUSIONS: Curettage offers an adequate alternative to surgical excision when performed during the first 2 weeks of life. Patients and parents are pleased with the cosmetic and functional results and thereby suffer less from the psychosocial inconvenience caused by these lesions. Careful long-term follow-up of these children is essential to monitor final cosmetic outcome and reduce the potential for malignancy.