Interventional study in 1,232 young German children to prevent the development of melanocytic nevi failed to change sun exposure and sun protective behavior

Sunscreens have been proposed as protective measures to inhibit the development of melanocytic nevi in childhood and to decrease the long term risk for cutaneous melanoma development. Our present study investigates the influence of sunscreen use and education on the number of incident melanocytic nevi. A total of 1,812 children in 78 public nursery schools in 2 German cities were randomized to 3 study arms: (i) parents were informed on study purpose and sun protection measures only at an initial educational meeting; (ii) parents received educational material 3 times yearly; and (iii) education and 800 ml free broad spectrum sunscreens with sun protection factor 25 provided on a yearly basis. Final assessment after 3 years follow-up included 1,232 children (68%). Changes of sun protection habits including sunscreen use were sparse, without any differences attributable to the intervention efforts. As a consequence, there were no significant differences between the 3 study arms for the main outcome measure, the number of incident melanocytic nevi. Analysis of the sunscreen use in the entire cohort irrespective of our study arms did not show any impact on incident nevus numbers in bivariate or multivariate analysis. In conclusion, intervention with educational letters and free sunscreens seemingly had no additional effect on sun-protection for German children. High prevalence of sunscreen use at study commencement, social desirability, and inadequate application of sunscreens might have partially covered their effect.