The natural tendency for infantile haemangiomas to involute makes it difficult to assess interventions such as pulsed dye laser (PDL) treatment. Furthermore, most studies have looked at early results, rather than the outcome at school age when psychosocial effects from existing lesions may arise. Therefore we studied the outcome at age 5 years in children assigned to PDL or observation in a prospective, randomized controlled trial. Results at 1 year reported previously showed no benefit of treatment except reduced erythema. A total of 121 infants aged 1-14 weeks with early haemangiomas were randomized to PDL treatment (n = 60) or observation (n = 61). Haemangiomas were treated during the early proliferative growth phase using a 585 nm PDL with a 3-5 mm spot diameter and energy fluences of 6-7AE5 J cm -2 , repeated at 2-4-week intervals. The main outcome measures at 1 year and 5 years were the proportion of lesions completely clear or with minimum residual signs, scarring including pigmentary disturbance, skin atrophy, skin wrinkling, the proportion requiring surgical correction, complications during the first year, the proportion of children whose parents considered the haemangioma to be a problem and haemangioma redness and height. Photographs were assessed independently by a panel of five parents blinded to treatment allocation status. Analysis was by intention to treat. Results at 1 year have been reported previously. One hundred and seventeen (97%) of the 121 children randomized were assessed at 5 years, 57 (95%) in the treatment and 60 (98%) in the observation group. The number of children whose lesions showed complete clearance (32 of 57, 56% vs. 27 of 60, 45%; P = 0AE31) or complete clearance/minimum residual signs (41, 72% vs. 48, 80%; P = 0AE39) was not significantly different in the PDL-treated and observation groups. However PDL-treated children were more likely to show skin scarring (28, 49% vs. 17, 28%; P = 0AE02). The number showing skin atrophy (13, 23% vs. 7, 12%; P = 0AE14) was similar between groups but treated children were more likely to have skin hypopigmentation (25, 44% vs. 14, 23%; P = 0AE03). The numbers of children requiring surgical correction (4, 7% vs. 2, 3%; P = 0AE43) were similar as were haemangioma height and redness. The number of children whose parents considered the haemangioma to be a problem at 5 years did not differ between the two groups (7, 12% vs. 6, 10%; P = 0AE92). A panel of independent parents validated this result. Our results do not show any long-term benefit of early PDL treatment in uncomplicated infantile haemangiomas. Furthermore treated lesions are at increased risk of scarring, particularly hypopigmentation, already apparent at 1 year and still present at 5 years. Although treatment reduced erythema at 1 year, residual erythema at school age was similar between groups.
