Get access

A randomized, multicentre study of directed daylight exposure times of 1½ vs. 2½ h in daylight-mediated photodynamic therapy with methyl aminolaevulinate in patients with multiple thin actinic keratoses of the face and scalp

Authors

  • S.R. Wiegell,

    1. Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
      *Clinic of Dermatology, Hans Edwarg Teglers Vej 9, 2920 Charlottenlund, Denmark
      †Department of Dermatology, Uppsala University, Uppsala University Hospital, 75185 Uppsala, Sweden
      ‡Department of Dermatology, Stavanger University Hospital, Norway
      §Clinic of Dermatology, Havnepladsen 31, 5700 Svendborg, Denmark
      ¶Department of Dermatology, Oslo University Hospital, Rikshospitalet HF, 0027 Oslo, Norway
      **Department of Dermatology and Venereology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden
      ††Department of Dermatology, University of Copenhagen, Roskilde Hospital, Køgevej 80, 400 Roskilde, Denmark
      ‡‡Clinic of Dermatology, Lille Sankt Pederstrœde 8, 8800 Viborg, Denmark
    Search for more papers by this author
  • S. Fabricius,

    1. Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
      *Clinic of Dermatology, Hans Edwarg Teglers Vej 9, 2920 Charlottenlund, Denmark
      †Department of Dermatology, Uppsala University, Uppsala University Hospital, 75185 Uppsala, Sweden
      ‡Department of Dermatology, Stavanger University Hospital, Norway
      §Clinic of Dermatology, Havnepladsen 31, 5700 Svendborg, Denmark
      ¶Department of Dermatology, Oslo University Hospital, Rikshospitalet HF, 0027 Oslo, Norway
      **Department of Dermatology and Venereology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden
      ††Department of Dermatology, University of Copenhagen, Roskilde Hospital, Køgevej 80, 400 Roskilde, Denmark
      ‡‡Clinic of Dermatology, Lille Sankt Pederstrœde 8, 8800 Viborg, Denmark
    Search for more papers by this author
  • I.M. Stender,

    1. Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
      *Clinic of Dermatology, Hans Edwarg Teglers Vej 9, 2920 Charlottenlund, Denmark
      †Department of Dermatology, Uppsala University, Uppsala University Hospital, 75185 Uppsala, Sweden
      ‡Department of Dermatology, Stavanger University Hospital, Norway
      §Clinic of Dermatology, Havnepladsen 31, 5700 Svendborg, Denmark
      ¶Department of Dermatology, Oslo University Hospital, Rikshospitalet HF, 0027 Oslo, Norway
      **Department of Dermatology and Venereology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden
      ††Department of Dermatology, University of Copenhagen, Roskilde Hospital, Køgevej 80, 400 Roskilde, Denmark
      ‡‡Clinic of Dermatology, Lille Sankt Pederstrœde 8, 8800 Viborg, Denmark
    Search for more papers by this author
  • B. Berne,

    1. Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
      *Clinic of Dermatology, Hans Edwarg Teglers Vej 9, 2920 Charlottenlund, Denmark
      †Department of Dermatology, Uppsala University, Uppsala University Hospital, 75185 Uppsala, Sweden
      ‡Department of Dermatology, Stavanger University Hospital, Norway
      §Clinic of Dermatology, Havnepladsen 31, 5700 Svendborg, Denmark
      ¶Department of Dermatology, Oslo University Hospital, Rikshospitalet HF, 0027 Oslo, Norway
      **Department of Dermatology and Venereology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden
      ††Department of Dermatology, University of Copenhagen, Roskilde Hospital, Køgevej 80, 400 Roskilde, Denmark
      ‡‡Clinic of Dermatology, Lille Sankt Pederstrœde 8, 8800 Viborg, Denmark
    Search for more papers by this author
  • S. Kroon,

    1. Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
      *Clinic of Dermatology, Hans Edwarg Teglers Vej 9, 2920 Charlottenlund, Denmark
      †Department of Dermatology, Uppsala University, Uppsala University Hospital, 75185 Uppsala, Sweden
      ‡Department of Dermatology, Stavanger University Hospital, Norway
      §Clinic of Dermatology, Havnepladsen 31, 5700 Svendborg, Denmark
      ¶Department of Dermatology, Oslo University Hospital, Rikshospitalet HF, 0027 Oslo, Norway
      **Department of Dermatology and Venereology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden
      ††Department of Dermatology, University of Copenhagen, Roskilde Hospital, Køgevej 80, 400 Roskilde, Denmark
      ‡‡Clinic of Dermatology, Lille Sankt Pederstrœde 8, 8800 Viborg, Denmark
    Search for more papers by this author
  • B.L. Andersen,

    1. Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
      *Clinic of Dermatology, Hans Edwarg Teglers Vej 9, 2920 Charlottenlund, Denmark
      †Department of Dermatology, Uppsala University, Uppsala University Hospital, 75185 Uppsala, Sweden
      ‡Department of Dermatology, Stavanger University Hospital, Norway
      §Clinic of Dermatology, Havnepladsen 31, 5700 Svendborg, Denmark
      ¶Department of Dermatology, Oslo University Hospital, Rikshospitalet HF, 0027 Oslo, Norway
      **Department of Dermatology and Venereology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden
      ††Department of Dermatology, University of Copenhagen, Roskilde Hospital, Køgevej 80, 400 Roskilde, Denmark
      ‡‡Clinic of Dermatology, Lille Sankt Pederstrœde 8, 8800 Viborg, Denmark
    Search for more papers by this author
  • C. Mørk,

    1. Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
      *Clinic of Dermatology, Hans Edwarg Teglers Vej 9, 2920 Charlottenlund, Denmark
      †Department of Dermatology, Uppsala University, Uppsala University Hospital, 75185 Uppsala, Sweden
      ‡Department of Dermatology, Stavanger University Hospital, Norway
      §Clinic of Dermatology, Havnepladsen 31, 5700 Svendborg, Denmark
      ¶Department of Dermatology, Oslo University Hospital, Rikshospitalet HF, 0027 Oslo, Norway
      **Department of Dermatology and Venereology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden
      ††Department of Dermatology, University of Copenhagen, Roskilde Hospital, Køgevej 80, 400 Roskilde, Denmark
      ‡‡Clinic of Dermatology, Lille Sankt Pederstrœde 8, 8800 Viborg, Denmark
    Search for more papers by this author
  • C. Sandberg,

    1. Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
      *Clinic of Dermatology, Hans Edwarg Teglers Vej 9, 2920 Charlottenlund, Denmark
      †Department of Dermatology, Uppsala University, Uppsala University Hospital, 75185 Uppsala, Sweden
      ‡Department of Dermatology, Stavanger University Hospital, Norway
      §Clinic of Dermatology, Havnepladsen 31, 5700 Svendborg, Denmark
      ¶Department of Dermatology, Oslo University Hospital, Rikshospitalet HF, 0027 Oslo, Norway
      **Department of Dermatology and Venereology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden
      ††Department of Dermatology, University of Copenhagen, Roskilde Hospital, Køgevej 80, 400 Roskilde, Denmark
      ‡‡Clinic of Dermatology, Lille Sankt Pederstrœde 8, 8800 Viborg, Denmark
    Search for more papers by this author
  • G.B.E. Jemec,

    1. Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
      *Clinic of Dermatology, Hans Edwarg Teglers Vej 9, 2920 Charlottenlund, Denmark
      †Department of Dermatology, Uppsala University, Uppsala University Hospital, 75185 Uppsala, Sweden
      ‡Department of Dermatology, Stavanger University Hospital, Norway
      §Clinic of Dermatology, Havnepladsen 31, 5700 Svendborg, Denmark
      ¶Department of Dermatology, Oslo University Hospital, Rikshospitalet HF, 0027 Oslo, Norway
      **Department of Dermatology and Venereology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden
      ††Department of Dermatology, University of Copenhagen, Roskilde Hospital, Køgevej 80, 400 Roskilde, Denmark
      ‡‡Clinic of Dermatology, Lille Sankt Pederstrœde 8, 8800 Viborg, Denmark
    Search for more papers by this author
  • M. Mogensen,

    1. Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
      *Clinic of Dermatology, Hans Edwarg Teglers Vej 9, 2920 Charlottenlund, Denmark
      †Department of Dermatology, Uppsala University, Uppsala University Hospital, 75185 Uppsala, Sweden
      ‡Department of Dermatology, Stavanger University Hospital, Norway
      §Clinic of Dermatology, Havnepladsen 31, 5700 Svendborg, Denmark
      ¶Department of Dermatology, Oslo University Hospital, Rikshospitalet HF, 0027 Oslo, Norway
      **Department of Dermatology and Venereology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden
      ††Department of Dermatology, University of Copenhagen, Roskilde Hospital, Køgevej 80, 400 Roskilde, Denmark
      ‡‡Clinic of Dermatology, Lille Sankt Pederstrœde 8, 8800 Viborg, Denmark
    Search for more papers by this author
  • K.M. Brocks,

    1. Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
      *Clinic of Dermatology, Hans Edwarg Teglers Vej 9, 2920 Charlottenlund, Denmark
      †Department of Dermatology, Uppsala University, Uppsala University Hospital, 75185 Uppsala, Sweden
      ‡Department of Dermatology, Stavanger University Hospital, Norway
      §Clinic of Dermatology, Havnepladsen 31, 5700 Svendborg, Denmark
      ¶Department of Dermatology, Oslo University Hospital, Rikshospitalet HF, 0027 Oslo, Norway
      **Department of Dermatology and Venereology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden
      ††Department of Dermatology, University of Copenhagen, Roskilde Hospital, Køgevej 80, 400 Roskilde, Denmark
      ‡‡Clinic of Dermatology, Lille Sankt Pederstrœde 8, 8800 Viborg, Denmark
    Search for more papers by this author
  • P.A. Philipsen,

    1. Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
      *Clinic of Dermatology, Hans Edwarg Teglers Vej 9, 2920 Charlottenlund, Denmark
      †Department of Dermatology, Uppsala University, Uppsala University Hospital, 75185 Uppsala, Sweden
      ‡Department of Dermatology, Stavanger University Hospital, Norway
      §Clinic of Dermatology, Havnepladsen 31, 5700 Svendborg, Denmark
      ¶Department of Dermatology, Oslo University Hospital, Rikshospitalet HF, 0027 Oslo, Norway
      **Department of Dermatology and Venereology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden
      ††Department of Dermatology, University of Copenhagen, Roskilde Hospital, Køgevej 80, 400 Roskilde, Denmark
      ‡‡Clinic of Dermatology, Lille Sankt Pederstrœde 8, 8800 Viborg, Denmark
    Search for more papers by this author
  • J. Heydenreich,

    1. Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
      *Clinic of Dermatology, Hans Edwarg Teglers Vej 9, 2920 Charlottenlund, Denmark
      †Department of Dermatology, Uppsala University, Uppsala University Hospital, 75185 Uppsala, Sweden
      ‡Department of Dermatology, Stavanger University Hospital, Norway
      §Clinic of Dermatology, Havnepladsen 31, 5700 Svendborg, Denmark
      ¶Department of Dermatology, Oslo University Hospital, Rikshospitalet HF, 0027 Oslo, Norway
      **Department of Dermatology and Venereology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden
      ††Department of Dermatology, University of Copenhagen, Roskilde Hospital, Køgevej 80, 400 Roskilde, Denmark
      ‡‡Clinic of Dermatology, Lille Sankt Pederstrœde 8, 8800 Viborg, Denmark
    Search for more papers by this author
  • M. Hædersdal,

    1. Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
      *Clinic of Dermatology, Hans Edwarg Teglers Vej 9, 2920 Charlottenlund, Denmark
      †Department of Dermatology, Uppsala University, Uppsala University Hospital, 75185 Uppsala, Sweden
      ‡Department of Dermatology, Stavanger University Hospital, Norway
      §Clinic of Dermatology, Havnepladsen 31, 5700 Svendborg, Denmark
      ¶Department of Dermatology, Oslo University Hospital, Rikshospitalet HF, 0027 Oslo, Norway
      **Department of Dermatology and Venereology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden
      ††Department of Dermatology, University of Copenhagen, Roskilde Hospital, Køgevej 80, 400 Roskilde, Denmark
      ‡‡Clinic of Dermatology, Lille Sankt Pederstrœde 8, 8800 Viborg, Denmark
    Search for more papers by this author
  • H.C. Wulf

    1. Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
      *Clinic of Dermatology, Hans Edwarg Teglers Vej 9, 2920 Charlottenlund, Denmark
      †Department of Dermatology, Uppsala University, Uppsala University Hospital, 75185 Uppsala, Sweden
      ‡Department of Dermatology, Stavanger University Hospital, Norway
      §Clinic of Dermatology, Havnepladsen 31, 5700 Svendborg, Denmark
      ¶Department of Dermatology, Oslo University Hospital, Rikshospitalet HF, 0027 Oslo, Norway
      **Department of Dermatology and Venereology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden
      ††Department of Dermatology, University of Copenhagen, Roskilde Hospital, Køgevej 80, 400 Roskilde, Denmark
      ‡‡Clinic of Dermatology, Lille Sankt Pederstrœde 8, 8800 Viborg, Denmark
    Search for more papers by this author

  • Funding sources
    Department of Dermatology, Bispebjerg Hospital, Copenhagen.

  • Conflicts of interest
    G.B.E.J. has received honoraria for speaking and research as well as an investigator grant from Photocure, Norway. B.B., S.K., H.C.W., C.M., M.H. and S.R.W. have received fees for speaking and travelling grants from Photocure/Galderma. B.L.A. has received fees for speaking from Galderma. C.S., K.M.B. and S.F. have received travelling grants form Photocure/Galderma. M.M., P.A.P. and J.H. have no conflict of interest.Trial registry: Clinical Trials.gov NCT 007 111 78

Stine Regin Wiegell.
E-mail: swie0001@bbh.regionh.dk

Summary

Background  Actinic keratoses (AKs) are common dysplastic skin lesions that may differentiate into invasive squamous cell carcinomas. Although a superior cosmetic outcome of photodynamic therapy (PDT) is advantageous compared with equally effective treatments such as cryotherapy and curettage, the inconvenience of clinic attendance and discomfort during therapy are significant drawbacks. Daylight-mediated PDT could potentially reduce these and may serve as an alternative to conventional PDT.

Objectives  To compare the efficacy of methyl aminolaevulinate (MAL)-PDT with 1½ vs. 2½ h of daylight exposure in a randomized multicentre study.

Methods  One hundred and twenty patients with a total of 1572 thin AKs of the face and scalp were randomized to either 1½- or 2½-h exposure groups. After gentle lesion preparation and application of a sunscreen of sun protection factor 20, MAL was applied to the entire treatment area. Immediately after, patients left the clinic and exposed themselves to daylight according to the randomization. Daylight exposure was monitored with a wristwatch dosimeter and patients scored their pain sensation during treatment.

Results  The mean lesion response rate at 3 months was 77% in the 1½-h group and 75% in the 2½-h group (= 0·57). The mean duration of daylight exposure was 131 and 187 min in the two groups. The mean overall effective light dose was 9·4 J cm−2 (range 0·2–28·3). Response rate was not associated with effective daylight dose, exposure duration, treatment centre, time of day or time of year during which the treatment was performed. Treatment was well tolerated, with a mean ± SD maximal pain score of 1·3 ± 1·5.

Conclusions  Daylight-mediated MAL-PDT is an effective, convenient and nearly pain-free treatment for patients with multiple thin AKs. Daylight-mediated PDT procedures were easily performed and 2 h of daylight exposure resulted in uniformly high response rates when conducted in the period from June to October in Nordic countries.

Ancillary