ALA-PDT therapy is an important new treatment modality which enhances already proven and successful laser and light source treatments. It must be remembered that, at the time of this writing, the only FDA-approved indication for ALA-PDT is for the treatment of nonhy-perkeratotic AKs on the face and scalp and treated with the blue light source after a 14- to 18-h drug incubation period. The clinical trials presented for photorejuvenation, acne vulgaris, HS, and sebaceous gland hyperplasia, and the methodology used by the investigators are all being performed as off-label clinical trials. Clinicians can use medicines in an off-label format; patients should be made aware of the off-label

use of these treatments and proper informed consents should be made prior to the actual treatments (Figs. 6.15, 6.16). Research into entities being treated with ALA-PDT is growing and more investigations will follow in the months and years to come.

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