Primary Outcome Measures:
- Subtypes of acne lesions including papules, pustules, cysts, open comedones, and closed comedones [ Time Frame: These outcomes will be measured at follow-up evaluation visits during the treatment series, and up to every four weeks following the final treatment for a total of up to12 weeks. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- cutaneous sebum production (optional) [ Time Frame: Sebum production will be measured at baseline, at follow-up evaluation visits during the treatment series, and up to every four weeks following the final laser treatment for a total of up to 12 weeks. ] [ Designated as safety issue: No ]
Intervention Details:
Device: V-Beam laser, Candela Corp., 595 nm wavelength
Subjects will receive a series of up to 6 laser therapy sessions with a treatment interval of from approximately 1 to 4 weeks. In all cases, laser treatment parameters will be within the guidelines normally used clinically with the V-Beam laser, and thus fluences used will not exceed 15 J/cm2.
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.
Purpose
