Funding sources Department of Dermatology, Bispebjerg Hospital, Copenhagen.
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
Article first published online: 5 APR 2011
© 2011 The Authors. BJD © 2011 British Association of Dermatologists
British Journal of Dermatology
Volume 164, Issue 5, pages 1083–1090, May 2011
How to Cite
Wiegell, S.R., Fabricius, S., Stender, I.M., Berne, B., Kroon, S., Andersen, B.L., Mørk, C., Sandberg, C., Jemec, G.B.E., Mogensen, M., Brocks, K.M., Philipsen, P.A., Heydenreich, J., Hædersdal, M. and Wulf, H.C. (2011), 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. British Journal of Dermatology, 164: 1083–1090. doi: 10.1111/j.1365-2133.2011.10209.x
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
- Issue published online: 26 APR 2011
- Article first published online: 5 APR 2011
- Accepted manuscript online: 11 JAN 2011 12:37AM EST
- Accepted for publication 23 December 2010
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 (P = 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.