The North Queensland "Sun-Safe Clothing" study: design and baseline results of a randomized trial to determine the effectiveness of sun-protective clothing in preventing melanocytic nevi.
In 1999, the authors began recruitment for a randomized controlled intervention trial aimed at preventing melanocytic nevi (moles) by minimizing sun exposure through the use of sun-protective clothing. The study involves 652 Caucasian children (75.6% response) aged 0-35 months from 25 child-care centers (n = 13 intervention and n = 12 control) living in the high-solar-irradiance environment of Townsville, Queensland, Australia. Children attending intervention centers wear investigator-provided garments made from fabrics with ultraviolet protection factors rated very good to excellent. Control centers continue to offer usual care. Three-year follow-up of all children will be completed in 2005. The main outcome measure is the number of new melanocytic nevi. At baseline, the two groups were similar with respect to nevi, phenotype, age, demographic characteristics, sun-protection habits, and history of sun exposure, except that more children from control versus intervention centers (2% and 0%, respectively; p = 0.006) had experienced painful sunburn with blistering. Higher melanocytic nevus counts were associated with more time spent outdoors and a history of sunburn, while sunscreen use, particularly during the mild winter months, appeared to have a protective effect. These findings further substantiate the hypothesis that nevus development in young children is related to sun exposure.