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A retrospective analysis of real-life practice of off-label photodynamic therapy using methyl aminolevulinate (MAL-PDT) in 20 Italian dermatology departments. Part 1: Inflammatory and aesthetic indications

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Abstract

Experimental investigations have demonstrated that photodynamic therapy (PDT) with methyl aminolevulinate (MAL) may be a useful treatment in several inflammatory skin disorders and aesthetic indications. To assess the effectiveness, tolerability and safety of off-label MAL-PDT in daily clinical practice in 20 Italian hospital centers, a retrospective observational study of medical records of patients treated for off-label inflammatory and aesthetic indications was carried out. In all patients standard treatment options had been either ineffective, unacceptably toxic, or medically contraindicated. Clinical data regarding 221 patients affected by 22 different diseases were collected. The most common off-label indication was acne vulgaris, with >75% improvement in 72.8% of patients. Other disorders of the sebaceous gland, i.e. acne rosacea, hidradenitis suppurativa and sebaceous hyperplasia, were less responsive. Alopecia areata did not show any improvement. Granuloma annulare and necrobiosis lipoidica showed marked or moderate response in the majority of treated patients. The rate of patients with complete remission was lower for inflammatory skin disorders with hyperkeratosis, i.e. psoriasis (6/17) and porokeratosis (3/16). The efficacy for lichenoid dermatoses was dependent on the clinical variant (erosive and scleroatrophic were more responsive than hypertrophic). Only 1 of 6 patients with Zoon balanitis had a marked improvement. MAL-PDT of venous leg ulcers, photo-aging and hypertrophic scars led to a marked remission in 3/5, 3/6 and 5/8 patients, respectively. The treatment had to be interrupted because of strong pain and burning in 24 patients. Long term adverse events were not registered. Most patients with marked improvement had lasting remission with overall excellent cosmetic outcomes. The present findings demonstrate a high interest in off-label uses of MAL-PDT for inflammatory skin disorders. According to the observed clinical responses, safety, and favorable cosmetic results, MAL-PDT seems to have a potential therapeutic role for the treatment of granulomatous dermal disorders and follicular inflammatory diseases whereas results in other conditions are less encouraging.

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References

  1. J. C. Kennedy, R. H. Pottier, and D. C. Pross, Photodynamic therapy with endogenous protoporphyrin IX: basic principles and present clinical experience, J. Photochem. Photobiol., B, 1990, 6, 143–148.

    Article  CAS  Google Scholar 

  2. B. Ortel, C. R. Shea, P. G. Calzavara-Pinton, Molecular mechanisms of photodynamic therapy, Front. Biosci., 2009, 14, 4157–4172.

    Article  CAS  Google Scholar 

  3. P. G. Calzavara-Pinton, M. Arisi, E. Sereni, and B. Ortel, A critical reappraisal of off-label indications for topical photodynamic therapy with aminolevulinic acid and methylaminolevulinate, Rev. Recent Clin. Trials, 2010, 5, 112–116.

    Article  CAS  Google Scholar 

  4. A. Klein, P. Babilas, S. Karrer, M. Landthaler, and R. M. Szeimies, Photodynamic therapy in dermatology–an update, J. Dtsch. Dermatol. Ges., 2008, 6, 839–845.

    Google Scholar 

  5. C. A. Morton, K. E. McKenna, and L. E. Rhodes, Guidelines for topical photodynamic therapy: update, Br. J. Dermatol., 2008, 159, 1245–1266.

    Article  CAS  Google Scholar 

  6. S. R. Wiegell, and H. C. Wulf, Photodynamic therapy of acnes vulgaris using methyl aminolaevulinate: a blinded, randomized, controlled trial, Br. J. Dermatol., 2006, 154, 969–976.

    Article  CAS  Google Scholar 

  7. R. Bissonnette, C. Maari, S. Nigen, N. Provost, and C. Bolduc, Photodynamic therapy with methylaminolevulinate 80 mg g−1 without occlusion improves acnes vulgaris, J. Drugs Dermatol., 2010, 11, 1347–1352.

    Google Scholar 

  8. L. E. Bryld, and G. B. Jemec, Photodynamic therapy in a series of rosacea patients, J. Eur. Acad. Dermatol. Venereol., 2007, 21, 1199–1202.

    CAS  Google Scholar 

  9. T. Horio, O. Horio, H. Miyauchi-Hashimoto, Photodynamic therapy of sebaceous hyperplasia with topical 5-aminolevulinic acid and slide projector, Br. J. Dermatol., 2003, 148, 1274–1276.

    Article  CAS  Google Scholar 

  10. M. H. Gold, V. L. Bradshaw, M. M. Boring, T. M. Bridges, J. A. Biron, and T. L. Lewis, Treatment of sebaceous gland hyperplasia by photodynamic therapy with 5-aminolevulinic acid and a blue light source or intense pulsed light source, J. Drugs Dermatol., 2004, 6, S6–S9.

    Google Scholar 

  11. S. H. Kim, J. E. Do, H. Y. Kang, E. S. Lee, and Y. C. Kim, Combination of topical 5-aminolevulinic acid-photodynamic therapy with carbon dioxide laser for sebaceous hyperplasia, J. Am. Acad. Dermatol., 2007, 56, 523–524.

    Article  Google Scholar 

  12. E. Sotiriou, Z. Apalla, F. Maliamani, and D. Ioannides, Treatment of recalcitrant hidradenitis suppurativa with photodynamic therapy: report of five cases, Clin. Exp. Dermatol., 2009, 34, e235–e236.

    Article  CAS  Google Scholar 

  13. R. Saraceno, M. Teoli, C. Casciello, and S. Chimenti, Methyl aminolaevulinate photodynamic therapy for the treatment of hidradenitis suppurativa and pilonidal cysts, Photodermatol., Photoimmunol. Photomed., 2009, 25, 164–165.

    Article  CAS  Google Scholar 

  14. A. Guglielmetti, J. Bedoya, M. Acuna, V. Leiva, and S. Gonzalez, Successful aminolevulinic acid photodynamic therapy for recalcitrant severe hidradenitis suppurativa, Photodermatol., Photoimmunol. Photomed., 2010, 26, 110–111.

    Article  Google Scholar 

  15. M. Fernández-Guarino, A. Harto, I. García-Morales, B. Pérez-García, J. M. Arrazola, P. Jaén, Failure to treat alopecia areata with photodynamic therapy, Clin. Exp. Dermatol., 2008, 33, 585–587.

    Article  Google Scholar 

  16. R. Bissonnette, J. Shapiro, H. Zeng, D. I. McLean, and H. Lui, Topical photodynamic therapy with 5-aminolaevulinic acid does not induce hair regrowth in patients with extensive alopecia areata, Br. J. Dermatol., 2000, 143, 1032–1035.

    Article  CAS  Google Scholar 

  17. D. W. C. Hunt, and A. H. Chan, Influence of photodynamic therapy on immunological aspects of disease–an update, Expert Opin. Invest. Drugs, 2000, 9, 807–817.

    Article  CAS  Google Scholar 

  18. P. Weisenseel, A. V. Kuznetsov, S. Molin, T. Ruzicka, C. Berking, and J. C. Prinz, Photodynamic therapy for granuloma annulare: more than a shot in the dark, Dermatology, 2008, 217, 329–332.

    Article  Google Scholar 

  19. S. Piaserico, E. Zattra, D. Linder, and A. Peserico, Generalized granuloma annulare treated with methylaminolevulinate photodynamic therapy, Dermatology, 2009, 218, 282–284.

    Article  CAS  Google Scholar 

  20. M. Heidenheim, and G. B. Jemec, Successful treatment of necrobiosis lipoidica diabeticorum with photodynamic therapy, Arch. Dermatol., 2006, 142, 1548–1550.

    Article  Google Scholar 

  21. V. De Giorgi, G. Buggiani, R. Rossi, S. Sestini, M. Grazzini, and T. Lotti, Successful topical photodynamic treatment of refractory necrobiosis lipoidica, Photodermatol., Photoimmunol. Photomed., 2008, 24, 332–333.

    Article  Google Scholar 

  22. C. Berking, J. Hegyi, P. Arenberger, T. Ruzicka, and G. B. Jemec, Photodynamic therapy of necrobiosis lipoidica–a multicenter study of 18 patients, Dermatology, 2009, 218, 136–139.

    Article  CAS  Google Scholar 

  23. C. Penrose, S. E. Mercer, H. Shim-Chang, Photodynamic therapy for the treatment of cutaneous sarcoidosis, J. Am. Acad. Dermatol., 2011, 65, e12–e14.

    Article  Google Scholar 

  24. S. Karrer, C. Abels, M. B. Wimmershoff, M. Landthaler, and R. M. Szeimies, Successful treatment of cutaneous sarcoidosis using topical photodynamic therapy, Arch. Dermatol., 2002, 138, 581–584.

    Article  Google Scholar 

  25. R. Batchelor, S. Lamb, V. Goulden, G. Stables, M. Goodfield, and W. Merchant, Photodynamic therapy for the treatment of morphoea, Clin. Exp. Dermatol., 2008, 33, 661–663.

    Article  CAS  Google Scholar 

  26. S. Karrer, C. Abels, M. Landthaler, and R. M. Szeimies, Topical photodynamic therapy for localized scleroderma, Acta Derm.-Venereol., 2000, 80, 26–27.

    Article  CAS  Google Scholar 

  27. Z. Nie, A. Bayat, F. Behzad, and L. E. Rhodes, Positive response of a recurrent keloid scar to topical methyl aminolevulinate-photodynamic therapy, Photodermatol., Photoimmunol. Photomed., 2010, 26, 330–332.

    Article  Google Scholar 

  28. S. M. Campbell, J. Tyrrell, R. Marshall, and A. Curnow, Effect of MAL-photodynamic therapy on hypertrophic scarring, Photodiagn. Photodyn. Ther., 2010, 7, 183–188.

    Article  CAS  Google Scholar 

  29. G. Sanclemente, L. Medina, J. F. Villa, L. M. Barrera, and H. I. Garcia, A prospective split-face double-blind randomized placebo-controlled trial to assess the efficacy of methyl aminolevulinate + red-light in patients with facial photodamage, J. Eur. Acad. Dermatol. Venereol., 2011, 25, 49–58.

    Article  CAS  Google Scholar 

  30. C. Zane, R. Capezzera, R. Sala, M. Venturini, P. G. Calzavara-Pinton, Clinical and echographic analysis of photodynamic therapy using methylaminolevulinate as sensitizer in the treatment of photodamaged facial skin, Lasers Surg. Med., 2007, 39, 203–209.

    Article  Google Scholar 

  31. C. Guillen, O. Sanmartin, A. Escudero, R. Botella-Estrada, A. Sevila, and P. Castejon, Photodynamic therapy for in situ squamous cell carcinoma on chronic radiation dermatitis after photosensitization with 5-aminolaevulinic acid, J. Eur. Acad. Dermatol. Venereol., 2000, 14, 298–300.

    Article  CAS  Google Scholar 

  32. T. H. Clayton, and P. V. Harrison, Photodynamic therapy for infected leg ulcers, Br. J. Dermatol., 2007, 156, 384–385.

    Article  CAS  Google Scholar 

  33. R. M. Strauss, S. Ogden, R. A. Sheehan-Dare, and V. Goulden, Leg ulceration after aminolaevulinic acid photodynamic therapy in a patient with peripheral vascular disease, Dermatology, 2003, 207, 85.

    Article  CAS  Google Scholar 

  34. M. Fernández Guarino, A. M. Ryan, A. Harto, B. Pérez-García, J. M. Arrázola, P. Jaén, Experience with photodynamic therapy in Hailey–Hailey disease, J. Dermatol. Treat., 2008, 19, 288–290.

    Article  Google Scholar 

  35. R. Ruiz-Rodriguez, J. G. Alvarez, P. Jaén, A. Acevedo, S. Córdoba, Photodynamic therapy with 5-aminolevulinic acid for recalcitrant familial benign pemphigus (Hailey–Hailey disease), J. Am. Acad. Dermatol., 2002, 47, 740–742.

    Article  Google Scholar 

  36. M. M. Kleinpenning, J. H. Kanis, T. Smits, P. E. van Erp, P. van de Kerkhof, and R. M. Gerritsen, The effects of keratolytic pretreatment prior to fluorescence diagnosis and photodynamic therapy with aminolevulinic acid-induced porphyrins in psoriasis, J. Dermatol. Treat., 2010, 21, 245–251.

    Article  CAS  Google Scholar 

  37. S. Vano-Galvan, M. Fernandez-Guarino, S. Beà-Ardebol, B. Perez, A. Harto, and P. Jaen, Successful treatment of erosive vulvar lichen sclerosus with methylaminolaevulinic acid and laser-mediated photodynamic therapy, J. Eur. Acad. Dermatol. Venereol., 2009, 23, 71–72.

    Article  CAS  Google Scholar 

  38. E. Sotiriou, D. Panagiotidou, and D. Ioannidis, An open trial of 5-aminolevulinic acid photodynamic therapy for vulvar lichen sclerosus, Eur. J. Obstet. Gynecol. Reprod. Biol., 2008, 141, 187–188.

    Article  Google Scholar 

  39. P. Hillemanns, M. Untch, F. Pröve, R. Baumgartner, M. Hillemanns, and M. Korell, Photodynamic therapy of vulvar lichen sclerosus with 5-aminolevulinic acid, Obstet. Gynecol., 1999, 93, 71–74.

    CAS  Google Scholar 

  40. A. Olejek, K. Steplewska, A. Gabriel, I. Kozak-Darmas, A. Jarek, S. Kellas-Sleczka, F. Bydliński, K. Sieroń-Stoltny, S. Horak, A. Chełmicki, A. Sieroń, Efficacy of photodynamic therapy in vulvar lichen sclerosus treatment based on immunohistochemical analysis of CD34, CD44, myelin basic protein, and Ki67 antibodies, Int. J. Gynecol. Cancer, 2010, 20, 879–887.

    Article  Google Scholar 

  41. F. A. Nayeemuddin, M. Wong, J. Yell, and L. E. Rhodes, Topical photodynamic therapy in disseminated superficial actinic porokeratosis, Clin. Exp. Dermatol., 2002, 27, 703–706.

    Article  CAS  Google Scholar 

  42. M. Fernández-Guarino, A. Harto, B. Pérez-Garcia, M. Martin-González, S. Urrutia, P. Jaén, Photodynamic therapy in disseminated superficial actinic porokeratosis, J. Eur. Acad. Dermatol. Venereol., 2009, 23, 176–177.

    Article  Google Scholar 

  43. S. Cavicchini, and A. Tourlaki, Successful treatment of disseminated superficial actinic porokeratosis with methyl aminolevulinate-photodynamic therapy, J. Dermatol. Treat., 2006, 17, 190–191.

    Article  Google Scholar 

  44. X. García-Navarro, J. R. Garcés, E. Baselga, and A. Alomar, Linear porokeratosis. Excellent response to photodynamic therapy, Arch. Dermatol., 2009, 145, 526–527.

    Article  Google Scholar 

  45. A. Romero-Maté, E. Castaño-Suárez, C. García-Donoso, C. Martínez-Morán, C. Meseguer-Yebra, and J. Borbujo, Treatment of recalcitrant cutaneous discoid lupus erythematosus with photodynamic therapy, Photodermatol., Photoimmunol. Photomed., 2010, 26, 156–158.

    Article  Google Scholar 

  46. M. Fernández-Guarino, B. Pérez-García, A. Harto, P. Jaén, Discoid lupus erythematosus: good response to treatment with photodynamic therapy, J. Eur. Acad. Dermatol. Venereol., 2008, 22, 1142–1143.

    Article  Google Scholar 

  47. P. E. Beattie, R. S. Dawe, J. Ferguson, and S. H. Ibbotson, Lack of efficacy and tolerability of topical PDT for psoriasis in comparison with narrowband UVB phototherapy, Clin. Exp. Dermatol., 2004, 29, 545–562.

    Article  Google Scholar 

  48. S. Radakovic-Fijan, U. Blecha-Thalhammer, V. Schleyer, R. M. Szeimies, T. Zwingers, H. Hönigsmann, and A. Tanew, Topical aminolevulinic acid-based photodynamic therapy as a treatment option for psoriasis? Results of a randomized, observer-blinded study, Br. J. Dermatol., 2005, 152, 279–283.

    Article  CAS  Google Scholar 

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Authors and Affiliations

  1. Department of Dermatology, University of Brescia, Brescia, Italy

    Pier Giacomo Calzavara-Pinton, Maria Teresa Rossi & Raffaella Sala

  2. The University of Chicago Medical Center, Chicago, Illinois, USA

    Erica Aronson

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  1. Pier Giacomo Calzavara-Pinton
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The Italian Group for Photodynamic Therapy

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Correspondence to Pier Giacomo Calzavara-Pinton.

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This article is published as part of a themed issue on current topics in photodermatology.

The Italian Group for Photodynamic Therapy: Piergiacomo Calzavara-Pinton, Maria Teresa Rossi, Raffaella Sala (Dermatology Department, University of Brescia), Nicola Arpaia (Dermatology Department II, University of Bari), Elena Cleopatra Burtica (Dermatology Department, University of Bologna), Paolo Amerio (Dermatology Department, Hospital SS. Annunziata, Chieti), Annarosa Virgili (Dermatology Department, Hospital S. Anna, Ferrara), Riccardo Rossi, Gionata Buggiani (Dermatology Department, University of Florence), Andrea Zanca (Dermatology Department, A.O. Carlo Poma, Mantua), Leonardo Bugatti (Dermatology Department, ASUR 5, Jesi), Dario Fai (Dermatology Department, Gagliano del Capo Hospital, Lecce), Elisa Cervadoro (Dermatology Department, USL 6, Livorno), Stefano Cavicchini (Dermatology Department I, University of Milan), Fabrizio Fantini (Dermatology Department, University of Modena), Gabriella Fabbrocini (Dermatology Department, University of Naples), Stefano Piaserico (Dermatology Department, University of Padua), Elisa Cervadoro (Dermatology Department, University of Pisa), Miriam Teoli (Dermatology Department, University Tor Vergata, Rome), Laura Eibenschutz (Dermatology Department, San Gallicano Institute, Rome), Fabrizio Arcangeli (Dermatology Department, Hospital S. Maria, Terni), Paolo Broganelli (Dermatology Department, University of Turin), Donatella Schena (Dermatology Department, University of Verona).

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Calzavara-Pinton, P.G., Rossi, M.T., Aronson, E. et al. A retrospective analysis of real-life practice of off-label photodynamic therapy using methyl aminolevulinate (MAL-PDT) in 20 Italian dermatology departments. Part 1: Inflammatory and aesthetic indications. Photochem Photobiol Sci 12, 148–157 (2013). https://doi.org/10.1039/c2pp25124h

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