Reduced Side-Effects Of Photodynamic Therapy For The Treatment Of Moderate To Severe Acne (i-PDT)
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): 20 % Aminolevulinic Acid; Red light only; Blue light only
Intervention type(s): Drug; Device; Device
Intervention description(s): topical medication for ALA-PDT and i-PDT; Red Light therapy; Blue light only
Other intervention name(s): 5-Aminulevulinic acid HCl (ALA): Levulan® Kerastic® (Dusa Pharmaceuticals, Inc, Wilmington, MA, USA) (Dusa Pharmaceuticals); Omnilux Revive; 635 nm - LED (Phototherapeutics, Cheshire, UK); Omnilux Blue; 415 nm LED (Phototherapeutics, Cheshire, UK)
Intervention MeSH terms: Aminolevulinic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne vulgaris; Photodynamic Therapy; Side-effects; Pain