REFERENCES
(1) Narayanan V. Tuberous sclerosis complex: genetics to pathogenesis. Pediatr Neurol 2003 Nov;29(5):404-409.
(2) Rumsey N, Clarke A, White P. Exploring the psychosocial concerns of outpatients with disfiguring conditions. J Wound Care 2003 Jul;12(7):247-252.
(3) Zweegers J, van der Vleuten CJ. The psychosocial impact of an infantile haemangioma on children and their parents. Arch Dis Child 2012 Oct;97(10):922-926.
(4) Biondo G, Greco S, Mavilia L, Mercuri SR. Treatment of nodular facial angiofibromas in tuberous sclerosis, using ultrapulse carbon dioxide laser. Clin Exp Dermatol 2014 Aug;39(6):738-740.
(5) Balestri R, Neri I, Patrizi A, Angileri L, Ricci L, Magnano M. Analysis of current data on the use of topical rapamycin in the treatment of facial angiofibromas in tuberous sclerosis complex. J Eur Acad Dermatol Venereol 2015 Jan;29(1):14-20.
(6) Koenig MK, Hebert AA, Roberson J, Samuels J, Slopis J, Woerner A, et al. Topical rapamycin therapy to alleviate the cutaneous manifestations of tuberous sclerosis complex: a double-blind, randomized, controlled trial to evaluate the safety and efficacy of topically applied rapamycin. Drugs R D 2012 Sep 1;12(3):121-126.
(7) Wataya-Kaneda M, Nakamura A, Tanaka M, Hayashi M, Matsumoto S, Yamamoto K, et al. Efficacy and Safety of Topical Sirolimus Therapy for Facial Angiofibromas in the Tuberous Sclerosis Complex : A Randomized Clinical Trial. JAMA Dermatol 2017 Jan 1;153(1):39-48.
(8) Koenig MK, Bell CS, Hebert AA, Roberson J, Samuels JA, Slopis JM, et al. Efficacy and Safety of Topical Rapamycin in Patients With Facial Angiofibromas Secondary to Tuberous Sclerosis Complex: The TREATMENT Randomized Clinical Trial. JAMA Dermatol 2018 Jul 1;154(7):773-780.
(9) Chen PL, Hong JB, Shen LJ, Chen YT, Wang SJ, Liao YH. The efficacy and safety of topical rapamycin-calcitriol for facial angiofibromas in patients with tuberous sclerosis complex: a prospective, double-blind, randomized clinical trial. Br J Dermatol 2020 Oct;183(4):655-663.
(10) Bougueon G, Lagarce F, Martin L, Pailhories H, Bastiat G, Vrignaud S. Formulation and characterization of a 0.1% rapamycin cream for the treatment of Tuberous Sclerosis Complex-related angiofibromas. Int J Pharm 2016 Jul 25;509(1-2):279-284.
(11) Le Guyader G, Vieillard V, Andrieux K, Rollo M, Thirion O, Wolkenstein P, et al. Long-term stability of 0.1% rapamycin hydrophilic gel in the treatment of facial angiofibromas. Eur J Hosp Pharm 2020 Mar;27(e1):e48-e52.
(12) Ghanbarzadeh S, Valizadeh H, Zakeri-Milani P. Application of response surface methodology in development of sirolimus liposomes prepared by thin film hydration technique. Bioimpacts 2013;3(2):75-81.
(13) Ghanbarzadeh S, Valizadeh H, Zakeri-Milani P. The effects of lyophilization on the physico-chemical stability of sirolimus liposomes. Adv Pharm Bull 2013;3(1):25-29.
(14) Salido R, Garnacho-Saucedo G, Cuevas-Asencio I, Ruano J, Galan-Gutierrez M, Velez A, et al. Sustained clinical effectiveness and favorable safety profile of topical sirolimus for tuberous sclerosis - associated facial angiofibroma. J Eur Acad Dermatol Venereol 2012 Oct;26(10):1315-1318.
(15) Tiedemann Svendsen M, Bygum A, Hansen LK, Broesby-Olsen S. Facial angiofibromas associated to tuberous sclerosis treated with topical sirolimus. Ugeskr Laeger 2013 Oct 21;175(43):2569-2570.
(16) Ministry of Health, Consumption and Social Welfare. Madrid, Spain. Royal Decree 175/2001, of 23 February, which approves the standards of correct preparation and quality control of magistral formulas and officinal preparations. Available at:https://www.boe.es/buscar/pdf/2001/BOE-A-2001-5185-consolidado.pdf.
(17) Ministry of Health, Consumption and Social Welfare. Madrid, Spain. Guide to Good Practice of Preparation of Medications in Hospital Pharmacy Services. June, 2014. Available at:https://www.mscbs.gob.es/profesionales/farmacia/pdf/GuiaBPP3.pdf.
(18) International Conference on Harmonisation. Validation of Analytical Procedures: Text and Methodology, 2015, 6–12. .
(19) Ministry of Health, Consumption and Social Welfare, by mandate of Law 29/2006, of July 26, on guarantee and rational use of medicines and health products.  National Drug Formulary. Madrid, Spain. 2019.; Available at:https://www.boe.es/biblioteca_juridica/abrir_pdf.php?id=PUB-NT-2019-112.
(20) Yoon HY, Chang IH, Goo YT, Kim CH, Kang TH, Kim SY, et al. Intravesical delivery of rapamycin via folate-modified liposomes dispersed in thermo-reversible hydrogel. Int J Nanomedicine 2019 Aug 5;14:6249-6268.
(21) Park J, Yun SK, Cho YS, Song KH, Kim HU. Treatment of angiofibromas in tuberous sclerosis complex: the effect of topical rapamycin and concomitant laser therapy. Dermatology 2014;228(1):37-41.
(22) Onyesom I, Lamprou DA, Sygellou L, Owusu-Ware SK, Antonijevic M, Chowdhry BZ, et al. Sirolimus encapsulated liposomes for cancer therapy: physicochemical and mechanical characterization of sirolimus distribution within liposome bilayers. Mol Pharm 2013 Nov 4;10(11):4281-4293.
(23) Rouf MA, Vural I, Renoir JM, Hincal AA. Development and characterization of liposomal formulations for rapamycin delivery and investigation of their antiproliferative effect on MCF7 cells. J Liposome Res 2009;19(4):322-331.
(24) Valizadeh H, Ghanbarzadeh S, Zakeri-Milani P. Fusogenic liposomal formulation of sirolimus: improvement of drug anti-proliferative effect on human T-cells. Drug Dev Ind Pharm 2015;41(9):1558-1565.
(25) Department of Health and Human Services. Centers for Disease Control and Prevention National Institute for Occupational Safety and Health. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014. Available in: https://www.cdc.gov/niosh/docs/2014-138/pdfs/2014-138.pdf. 2014; . Accessed 19/06, 2019.
(26) Cortell Fuster C, Martínez Gómez MA, Cercós Lleti AC, Climente Martí M. Topical rapamycin in the treatment of facial angiofibromas in tuberous sclerosis: a systematic review based on evidence. J Dermatolog Treat 2021 Apr 6:1-7.