Reduced Side-Effects Of Photodynamic Therapy For The Treatment Of Moderate To Severe Acne (i-PDT)

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.

Inclusion criteria

1. Subjects with ages between 14 and 50 years, male or female.

2. Subjects with severe acne lesions (one or more nodules or cysts present) on their
backs or face

3. Presence of moderate acne on the back and/or face that has been recalcitrant to
previous treatments. Recalcitrant acne is acne with no or mild/temporary (less than 3
months) improvement after using:

- Accutane® for at least one completed treatment cycle, and/or

- Oral antibiotic for ≥ 3 months; and/or

- Topical prescription retinoids (tretinoin - retinoic acid, adapalene, tazarotene
or other derivatives) for ≥ 3 months, and/or

- Topical benzoyl peroxide 2.5% or higher concentrations for ≥ 3 months

- Hormonal treatments** for ≥ 3 months.

4. Willingness to participate in the study

5. Willingness to receive ALA-PDT treatment

6. Informed consent agreement signed by the subject

7. Willingness to follow the treatment schedule and post treatment care requirements

8. Willingness to not use topical or systemic (oral) anti-acne medications including
medicated shampoo or soap during the study period.

Exclusion criteria

1. Subjects receiving concurrent oral retinoids or antibiotics

** Subjects with chronic use of antibiotics may be included if proven that its use
has not changed the severity of their acne. AND

*** Chronic use of antibiotic is considered ≥ 2 years of continuous use.

2. Scarring or infection of the area to be treated

3. Known photosensitivity

4. Presence of suntan in the area to be treated

5. Subjects who have taken medication known to induce photosensitivity in the previous 3
months

6. Subjects who have had prior oral retinoid (Accutane®) use within 6 months of entering
the study

7. Prior oral antibiotic use within 1 month of entering the study (see exclusion #1)

8. Topical antibiotic or other topical anti-acne treatments use within 2 weeks of
entering the study

9. Known anticoagulation or thromboembolic condition

10. Subjects who are immunosuppressed

11. Subject is unable to comply with treatment, home care or follow-up visits

12. Subject is pregnant or breast feeding

13. Subject has a history of being on photosensitive medications (thiazides [used to
treat high blood pressure], tetracyclines, fluoroquinolones griseofulvin or
sulfonamides [used to treat infections], sulfonylureas [used to treat diabetes],
calcium channel blockers [used to treat hypertension]. phenothiazines [used to treat
serious emotional problems]).

14. Known skin sensitivity to blue light

15. Porphyria (a disorder of the metabolism that can lead to sensitivity to light)

16. Allergies to chemicals called porphyrins

17. Subjects who started hormonal treatment (for medical conditions or birth control)
within less than 3 months.