BACKGROUND:Telangiectatic leg veins (TLV) represent a common cosmetic problem. Near infrared lasers have been widely used in treatment because of their deeper penetration into the dermis, but with varying degrees of success, particularly because of different vessel diameters. Indocyanine green (ICG)-augmented diode laser treatment (ICG+DL) may present an alternative treatment option. OBJECTIVES: This trial evaluates the efficacy of ICG+DL in the treatment of TLV and compares the safety and efficacy of therapy with the standard treatment, the long-pulsed neodymium-doped yttrium aluminium garnet (Nd:YAG) laser. METHODS: In a prospective randomized controlled clinical trial, 29 study participants with TLV were treated with a Nd:YAG laser (λem = 1064 nm, 160-240 J cm(-2) , 65-ms pulse duration, 5-mm spot size) and ICG+DL (λem = 810 nm, 60-110 J cm(-2) , 48-87-ms pulse duration, 6-mm spot size; total ICG dose 4 mg kg(-1) ) in a side-by-side comparison in one single treatment setting that included histological examination in four participants. Two blinded investigators and the participants assessed clearance rate, cosmetic appearance and adverse events up to 3 months after treatment. RESULTS: According to both the investigators' and participants' assessment, clearance rates were significantly better after ICG+DL therapy than after Nd:YAGlaser treatment (P < 0·05). On a 10-point scale indicating pain during treatment, participants rated ICG+DL therapy to be more painful (6·1 ± 2·0) than Nd:YAG laser (5·4 ± 2·0). CONCLUSIONS:ICG+DL therapy represents a new and promising treatment modality for TLV, with high clearance rates and a very good cosmetic outcome after one single treatment session.
RCT Entities:
BACKGROUND:Telangiectatic leg veins (TLV) represent a common cosmetic problem. Near infrared lasers have been widely used in treatment because of their deeper penetration into the dermis, but with varying degrees of success, particularly because of different vessel diameters. Indocyanine green (ICG)-augmented diode laser treatment (ICG+DL) may present an alternative treatment option. OBJECTIVES: This trial evaluates the efficacy of ICG+DL in the treatment of TLV and compares the safety and efficacy of therapy with the standard treatment, the long-pulsed neodymium-doped yttrium aluminium garnet (Nd:YAG) laser. METHODS: In a prospective randomized controlled clinical trial, 29 study participants with TLV were treated with a Nd:YAG laser (λem = 1064 nm, 160-240 J cm(-2) , 65-ms pulse duration, 5-mm spot size) and ICG+DL (λem = 810 nm, 60-110 J cm(-2) , 48-87-ms pulse duration, 6-mm spot size; total ICG dose 4 mg kg(-1) ) in a side-by-side comparison in one single treatment setting that included histological examination in four participants. Two blinded investigators and the participants assessed clearance rate, cosmetic appearance and adverse events up to 3 months after treatment. RESULTS: According to both the investigators' and participants' assessment, clearance rates were significantly better after ICG+DL therapy than after Nd:YAG laser treatment (P < 0·05). On a 10-point scale indicating pain during treatment, participants rated ICG+DL therapy to be more painful (6·1 ± 2·0) than Nd:YAG laser (5·4 ± 2·0). CONCLUSIONS:ICG+DL therapy represents a new and promising treatment modality for TLV, with high clearance rates and a very good cosmetic outcome after one single treatment session.
Authors: Arne A Meesters; Luiza H U Pitassi; Valeria Campos; Albert Wolkerstorfer; Christine C Dierickx Journal: Lasers Med Sci Date: 2013-11-13 Impact factor: 3.161