BACKGROUND AND OBJECTIVES: Childhood hemangioma is the most common soft tissue tumor of infancy, occurring in 10% of children younger than 1 year old. Ten percent of these infantile hemangiomas involute yearly without intervention. Treatment with the pulsed dye laser (PDL) is the criterion standard for treating vascular lesions. It is well established as the most effective, safest treatment for port-wine stains. Previous studies of the use of PDL treatment in superficial hemangioma showed inconsistent results. Main objectives were to compare the efficacy and adverse effects of PDL treatment with those of observation in the treatment of superficial hemangiomas. Parental quality of life was also assessed. MATERIALS AND METHODS: This was a prospective, randomized, controlled trial in which we enrolled 22 infants aged 1.5 to 5 months old with early hemangiomas with a maximum diameter of 5 cm. We assigned the infants to PDL treatment (n = 11) or observation (n = 11), and followed up until the age of 1 year. Patients in the intervention group were treated using a 595-nm PDL (VBEAM, Candela Corp., Wayland, MA) with a 7-mm spot diameter, 30/10 to 40/10-ms epidermal cooling, a 7- to 15-J/cm(2) fluence range, and a pulse duration of 0.45 to 40.0 ms. During follow-up, color measurements were made (Colori meter; Minolta, Tokyo, Japan), and surface area and echo depth of the hemangioma were determined. RESULTS: No significant differences were seen between the groups at time of inclusion or at the age of 1 year in echo depth (p = .66) or surface area (p = .62). Results were significant for color difference (p = .03) between PDL treatment and observation. Cosmetic outcome judged by an independent panel consisting of a dermatologist, physician assistant, dermatology resident, dermatology nurse, and plastic surgery resident was significantly better in the PDL treatment group (46%) than in the observation group (18%) (p = .006). CONCLUSIONS:Pulsed dye laser is only to be considered as an alternative treatment up to the age of 6 months, at which time parents and physicians consider cosmetic outcome to be a relevant factor, but laser therapy plays a major role in the treatment of residual lesions at older ages.
RCT Entities:
BACKGROUND AND OBJECTIVES: Childhood hemangioma is the most common soft tissue tumor of infancy, occurring in 10% of children younger than 1 year old. Ten percent of these infantile hemangiomas involute yearly without intervention. Treatment with the pulsed dye laser (PDL) is the criterion standard for treating vascular lesions. It is well established as the most effective, safest treatment for port-wine stains. Previous studies of the use of PDL treatment in superficial hemangioma showed inconsistent results. Main objectives were to compare the efficacy and adverse effects of PDL treatment with those of observation in the treatment of superficial hemangiomas. Parental quality of life was also assessed. MATERIALS AND METHODS: This was a prospective, randomized, controlled trial in which we enrolled 22 infants aged 1.5 to 5 months old with early hemangiomas with a maximum diameter of 5 cm. We assigned the infants to PDL treatment (n = 11) or observation (n = 11), and followed up until the age of 1 year. Patients in the intervention group were treated using a 595-nm PDL (VBEAM, Candela Corp., Wayland, MA) with a 7-mm spot diameter, 30/10 to 40/10-ms epidermal cooling, a 7- to 15-J/cm(2) fluence range, and a pulse duration of 0.45 to 40.0 ms. During follow-up, color measurements were made (Colori meter; Minolta, Tokyo, Japan), and surface area and echo depth of the hemangioma were determined. RESULTS: No significant differences were seen between the groups at time of inclusion or at the age of 1 year in echo depth (p = .66) or surface area (p = .62). Results were significant for color difference (p = .03) between PDL treatment and observation. Cosmetic outcome judged by an independent panel consisting of a dermatologist, physician assistant, dermatology resident, dermatology nurse, and plastic surgery resident was significantly better in the PDL treatment group (46%) than in the observation group (18%) (p = .006). CONCLUSIONS: Pulsed dye laser is only to be considered as an alternative treatment up to the age of 6 months, at which time parents and physicians consider cosmetic outcome to be a relevant factor, but laser therapy plays a major role in the treatment of residual lesions at older ages.