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Randomized Controlled Trial
. 2016 Mar;42(3):296-304.
doi: 10.1097/DSS.0000000000000630.

Randomized Vehicle-Controlled Study of Short Drug Incubation Aminolevulinic Acid Photodynamic Therapy for Actinic Keratoses of the Face or Scalp

David M Pariser  1 , Anna Houlihan, Mary Beth Ferdon, James E Berg; PDT-AK Investigational Group
Collaborators, Affiliations
Randomized Controlled Trial

Randomized Vehicle-Controlled Study of Short Drug Incubation Aminolevulinic Acid Photodynamic Therapy for Actinic Keratoses of the Face or Scalp

David M Pariser et al. Dermatol Surg. 2016 Mar.

Abstract

Background: Aminolevulinic acid photodynamic therapy (ALA-PDT) can be effective and well tolerated when applied over a broad area and for short drug incubation times.

Objective: To evaluate the effect of short-incubation time and application method on the safety and efficacy of ALA-PDT versus vehicle (VEH-PDT) in the treatment of actinic keratoses (AKs) of the face or scalp.

Methods: Aminolevulinic acid or VEH was applied to face or scalp as a broad area application for 1, 2, or 3 hours or as a spot application for 2 hours before blue light activation. An identical treatment was repeated at Week 8 if any AK lesions remained.

Results: Median AK clearance rate for ALA-treated subjects ranged from 68% to 79% at Week 12, compared with 7% of the VEH-treated group (p < .0001). Complete clearance rate for ALA-treated subjects ranged from 17% (8/46) to 30% (14/47) at Week 12, compared with 2% (1/46) of the VEH-treated group (p = .0041). The safety profile seen in this study is consistent with previously reported side effects of the therapy.

Conclusion: Short-incubation ALA-PDT was found to be superior to VEH-PDT for AK lesion clearance. A second treatment improves efficacy.

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Conflict of interest statement

Anna Houlihan and Stuart Marcus of the PDT-AK Investigational Group are both employed by DUSA Pharmaceuticals, Inc.

Figures

Figure 1
Figure 1
Median AK lesion clearance rate by visit. *There were statistically significant differences (p < .0001) in median AKCR between the 5 treatment groups at all visits; the pairwise comparisons of ALA versus VEH were statistically significant (ALA > VEH; p < .001) for all treatment groups at all visits. In this figure, error bars represent standard error.
See this image and copyright information in PMC

References

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