Topical rapamycin combined with pulsed dye laser in the treatment of capillary vascular malformations in Sturge-Weber syndrome: Phase II, randomized, double-blind, intraindividual placebo-controlled clinical trial
Por:
Marques, L, Nunez-Cordoba, JM, Aguado, L, Pretel, M, Boixeda, P, Nagore, E, Baselga, E, Redondo, P
Publicada:
1 ene 2015
Resumen:
Background: Sturge-Weber syndrome (SWS) is characterized by port-wine stains (PWS) affecting the face, eyes, and central nervous system. Pulsed dye laser (PDL) is the standard treatment for PWS. Unfortunately, recurrence is frequent because of reformation and reperfusion of blood vessels.
Objective: We sought to assess the clinical efficacy of topical rapamycin combined with PDL in PWS of patients with SWS.
Methods: We conducted a phase II, randomized, double-blind, intraindividual placebo-controlled, clinical trial. We recruited 23 patients with SWS and facial PWS (12 women; median age 33 years, age range 17-65 years) from the University Clinic of Navarra, Spain. Four interventions were evaluated: placebo, PDL 1 placebo, rapamycin, and PDL + rapamycin. Clinical and histologic responses were evaluated using a chromatographic computerized system, spectrometry, and histologic analyses at 6, 12, and 18 weeks after the intervention.
Results: PDL + rapamycin yielded the lowest digital photographic image score and the lowest percentage of vessels in histologic analysis, and showed a statistically significant improvement compared with the other interventions. The treatment was generally well tolerated.
Limitations: PDL was only applied to the lateral parts of the PWS area.
Conclusion: Topical rapamycin associated with PDL seems to be an effective treatment for PWS in patients with SWS.
Filiaciones:
Marques, L:
Univ Navarra Clin, Dept Dermatol, Navarra 31008, Spain
Nunez-Cordoba, JM:
Univ Navarra Clin, Sch Med, Dept Prevent Med & Publ Hlth, Navarra 31008, Spain
Aguado, L:
Univ Navarra Clin, Dept Dermatol, Navarra 31008, Spain
Pretel, M:
Univ Navarra Clin, Dept Dermatol, Navarra 31008, Spain
Boixeda, P:
Hosp Ramon & Cajal, Dept Dermatol, E-28034 Madrid, Spain
Nagore, E:
Univ Catolica Valencia, Inst Valenciano Oncol, Dept Dermatol, Valencia, Spain
Baselga, E:
Hosp St Pau & Santa Creu, Dept Dermatol, Barcelona, Spain
Redondo, P:
Univ Navarra Clin, Dept Dermatol, Navarra 31008, Spain
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