The purpose of this research project is to study the effect of non-ablative (non-cutting)
laser therapy, a technique that uses laser energy to try to improve the appearance of the
skin. This type of laser treatment creates changes in a layer of the skin called the dermis
without causing an open wound in the skin. The use of non-ablative laser therapy, together
with application of a photo-sensitizer (substance that makes the skin more sensitive to
light), may improve the appearance of acne. The idea behind the photo-sensitizer is that it
is supposed to make the laser more effective than using just the laser alone. It is not yet
clear how much improvement can be seen with these treatments or exactly how the skin's
response causes these improvements. In this study, we are interested in learning how well
such a laser works to improve the symptoms of acne, as well as how much the photo-sensitizer
actually enhances the efficacy of the laser.
Acne vulgaris remains among the most common cutaneous disorders, impacting the vast majority
of people at some point during their lives. It is associated with significant psychosocial
morbidity, and there remains the need for efficacious and low risk therapeutic options.
Recently, the FDA has approved various lasers for the treatment of acne. However, few
randomized, controlled clinical trials have been performed. In addition, the use of topical
photosensitizers preceding laser therapy for acne has also been examined in a preliminary
way with some initial evidence of efficacy. However, these small trials have primarily
focused on back acne and have included modest numbers of subjects. Photodynamic therapy for
facial acne is being performed by physicians across the country but little objective data
regarding this practice is available.
We propose to evaluate the efficacy and confirm the safety of pulsed dye laser therapy
(V-Beam laser, Candela Corp., Wayland, MA, 595 nm wavelength) used in conjunction with a
topical photosensitizer in the treatment of acne vulgaris. This is a split-face comparison
study in which one half of the face will be treated with photo-sensitizer and laser, and the
contralateral side will be left untreated. Because one proposed mechanism of action for
such treatments includes altered sebaceous gland activity, we also seek to examine the
effects of this treatment on cutaneous sebum production.
- Age 15 years or older of either gender and of any racial/ethnic group.
- Presence of clinically-evident facial acne.
- Subjects must be in generally good health.
- Subjects must be able and willing to comply with the requirements of the protocol.
- You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be
able to attend all of the scheduled appointments during the study.
- Oral retinoid (Accutane) use within 6 months of entry into the study.
- Systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study.
- Topical acne therapies (retinoids, antibiotics) within 2 weeks of entry into the
- Microdermabrasion or superficial chemical peels at the sites to be treated within 2
months of entry into the study.
- Subjects with a history of dermabrasion or laser resurfacing at the sites to be
- Use of topical lipid absorbing substances (Clinac AC) within 2 weeks of entry into
- Non-compliant subjects.
- Subjects with a significant medical history or concurrent illness/condition which the
investigator(s) feel is not safe for study participation.
- Subjects using alcohol-based topical solutions or "exfolliating" agents within 2
weeks of entry into the study.
- Subjects with a history of very frequent herpes simplex infections of the face or
with clinical evidence of active herpes simplex infections.
- History of keloid (excessive scar) formation for subjects undergoing biopsies.
- Pregnant or nursing females.
- Subjects with known allergy or hypersensitivity to topical photosensitizing agents.
- Subjects with known photosensitivity disorders felt by the investigators to preclude
safe inclusion in the study.