Acne Vulgaris Clinical Trial
Official title:
A Pilot Clinical Trial To Reduce Side-Effects Of Photodynamic Therapy For The Treatment Of Moderate To Severe Acne
This research study aims to compare different methods for helping difficult to treat or
scarring (cystic) acne, ALA-PDT and i-PDT.
There is an investigational procedure called photodynamic therapy (ALA-PDT) that has been
reported to be very efficient for acne treatment since 2000. Photodynamic therapy (PDT) uses
a drug called ALA (aminolevulinic acid), which is marketed as Levulan®.
Levulan® is applied directly to facial/back acne. This is the way that it is usually applied.
Levulan® is left on the skin for three hours so the skin can absorb it. Next, the skin where
the Levulan® was applied is exposed to a red light for activation.
The sebaceous glands get obstructed and inflamed causing acne. ALA gets down under your skin
through the skin pores to where the glands are. PDT destroys the glands reducing the acne
lesion.
Levulan® is absorbed by normal skin surrounding the oil glands. Therefore, this procedure
also has some side effects. Some of the side effects include pain, burning sensation during
the procedure, and redness, tenderness, and swelling after the procedure.
At Massachusetts General Hospital's Wellman Center for Photomedicine, the investigators
developed another procedure called inhibitory-PDT (i-PDT) that is similar to ALA-PDT. i-PDT
is aimed at reducing the side-effects of ALA- PDT.
The difference between these two procedures is that i-PDT uses a light source that will
prevent Levulan® accumulation in the normal skin surface. The investigators would like to
find out if Levulan® will be placed only inside the sebaceous glands.
This is a pilot study to compare efficacy and side effects i-PDT and ALA-PDT. All subjects
will receive ALA-PDT and i-PDT. Face or back regions will be divided into two sides, the
right and left. One half of the face or back will receive ALA-PDT and the other half will
receive i-PDT. For subjects with back acne, red light and blue light alone will be applied
for comparison.
Healthy subjects with difficult to treat moderate or severe acne on the face or back are
eligible to enroll.
The investigators will enroll about 35 patients at Massachusetts General Hospital (MGH) with
follow-ups 1, 3 and 6 months after treatment.
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