Journal of the American Academy of Dermatology
Volume 59, Issue 4 , Pages 569-576, October 2008

Topical methyl-aminolevulinate photodynamic therapy using red light-emitting diode light for treatment of multiple actinic keratoses: A randomized, double-blind, placebo-controlled study

  • David Pariser, MD

      Affiliations

    • Eastern Virginia Medical School, Division of Dermatology and Virginia Clinical Research Inc, Norfolk, Virginia
    • Corresponding Author InformationCorrespondence to: David Pariser, MD, Eastern Virginia Medical School, Division of Dermatology and Virginia Clinical Research Inc, 301 Medical Tower, Norfolk, VA 23507.
    • ,
  • Robert Loss, MD

      Affiliations

    • Dermatology Associates of Rochester, Rochester, New York
    • ,
  • Michael Jarratt, MD

      Affiliations

    • DermResearch Inc, Austin, Texas
    • ,
  • William Abramovits, MD

      Affiliations

    • Texas Dermatology Research Institute, Dallas, Texas
    • ,
  • James Spencer, MD

      Affiliations

    • Spencer Dermatology and Skin Surgery Center, Saint Petersburg, Florida
    • ,
  • Roy Geronemus, MD

      Affiliations

    • Laser and Skin Surgery Center of NYC, New York, New York
    • ,
  • Philip Bailin, MD

      Affiliations

    • Department of Dermatology, Cleveland Clinic Foundation, Cleveland, Ohio
    • ,
  • Suzanne Bruce, MD

      Affiliations

    • Suzanne Bruce and Associates PA, The Center for Skin Research, Houston, Texas

Accepted 18 May 2008. published online 15 August 2008.

Background

The use of light-emitting diode light offers practical advantages in photodynamic therapy (PDT) with topical methyl-aminolevulinate (MAL) for management of actinic keratoses (AK).

Objective

We sought to evaluate the efficacy of MAL PDT using red light-emitting diode light.

Methods

We conducted a multicenter, double-blind, randomized study. A total of 49 patients with 363 AK lesions had 16.8% MAL cream applied under occlusion for 3 hours, and 47 patients with 360 AK lesions had vehicle cream similarly applied. The lesions were then illuminated (630 nm, light dose 37 J/cm2) with repeated treatment 1 week later. Complete lesion and patient (all lesions showing complete response) response rates were evaluated 3 months after last treatment.

Results

MAL PDT was superior (P < .0001) to vehicle PDT with respect to lesion complete response (86.2% vs 52.2%, odds ratio 6.9 [95% confidence interval 4.7-10.3]) and patient complete response (59.2% vs 14.9%, odds ratio 13.2 [95% confidence interval 4.1-43.1]).

Limitations

The study population may not be representative of all patients with AK.

Conclusion

MAL PDT using red light-emitting diode light is an appropriate treatment alternative for multiple AK lesions.

Abbreviations used: AK, actinic keratoses, CI, confidence interval, LED, light-emitting diode, MAL, methyl-aminolevulinate, PDT, photodynamic therapy

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 Supported by PhotoCure ASA, Oslo, Norway.

 Disclosure: The authors certify that, to their knowledge, the work that is reported on in said manuscript has not received financial support from any pharmaceutical company or other commercial source except as described below. Neither the authors nor any first-degree relative have any special financial interest in the subject matter discussed in said manuscript. Dr Pariser has received grants for participation in clinical trials from PhotoCure ASA, Galderma, and DUSA. Dr Loss has received grants for participation in clinical trials from DOW, Genentech, Connetics, Allergan, Galderma, Hill, Centocor, Stiefel, and Novartis. Dr Abramovits has received grants for participation in clinical trials from Galderma. Dr Bruce has received grants for participation in clinical trials from Allergan, Medicis, Altana, Astellas, Galderma, 3M, Connetics, Obagi, Dow, DUSA, Hill, Isolagen, Novartis, Contura, and Anacor; has received honoraria for participation in advisory boards from Allergan and Syneron; has received honoraria as a consultant for Dermik and Medicis; and has received honoraria as a speaker for Dermik and Obagi. All authors received a grant for participation in this trial from PhotoCure ASA.

 Reprints not available from the authors.

PII: S0190-9622(08)00662-2

doi:10.1016/j.jaad.2008.05.031

Journal of the American Academy of Dermatology
Volume 59, Issue 4 , Pages 569-576, October 2008

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