A multicenter clinical evaluation of the treatment of mild to moderate inflammatory acne vulgaris of the face with visible blue light in comparison to topical 1% clindamycin antibiotic solution

Journal of Drugs in Dermatology, Jan-Feb, 2005 by Michael H. Gold, Jaggi Rao, Mitchel P. Goldman, Tancy M. Bridges, Virginia L. Bradshaw, Molly M. Boring, April N. Guider

Abstract

Background: Blue light sources have been shown to be effective in the treatment of mild to moderate inflammatory acne vulgaris lesions.

Objective: We evaluated the safety and efficacy of a new blue light source in the treatment of mild to moderate inflammatory acne vulgaris in comparison to topical 1% clindamycin solution.

Results: Blue light therapy reduced inflammatory acne vulgaris lesions by an average of 34%, as compared to 14% for topical 1% clindamycin solution.

Conclusions: The blue light source presented in this report is a safe and effective treatment option available to our patients with mild to moderate inflammatory acne lesions.

**********

Introduction

The traditional treatment of acne vulgaris involves the use of a variety of topical and systemic medications. Recently, a new group of blue light sources has entered into the acne treatment therapeutic armamentarium to treat mild to moderate inflammatory acne vulgaris. These light sources are finding a useful niche for those seeking alternative/additional treatment options for this, at times, frustrating disease to treat. The purpose of this clinical trial was to evaluate the safety and efficacy of a new blue light source, the Blu-U[TM] Blue Light Photodynamic Therapy Illuminator Model 4170 (Dusa Pharmaceuticals, Wilmington, MA), Figure 1, in comparison to topical 1% clindamycin solution Cleocin T[TM] solution (UpJohn Pharmaceutical, Kalamazoo, MI) in the treatment of mild to moderate inflammatory acne vulgaris. Both the Blu-U and topical 1% clindamycin topical solution are approved/cleared for the treatment of acne vulgaris by the U.S. Food and Drug Administration (FDA). Topical 1% clindamycin solution is a successful and useful topical acne vulgaris therapy. Many studies have used this compound as a marker when evaluating new acne vulgaris therapies. (1) The Blu-U Blue Light Photodynamic Therapy Illuminator is an electrical Class I, Type B device which has FDA clearance for the treatment of moderate inflammatory acne vulgaris and in combination with Levulan[R] Kerastick[TM] (Dusa Pharmaceuticals, Wilmington, MA) (aminolevulinic acid HCl) for the treatment of non-hyperkeratotic actinic keratoses of the face and scalp.

Materials and Methods

This clinical trial was a 2-center, randomized, investigator-blinded pilot study comparing the safety and efficacy of blue light alone compared to topical 1% clindamycin solution therapy in patients with mild to moderate inflammatory acne vulgaris of the face. The clinical trial was performed under the auspices of an institutional review board. The study design consisted of a 1-week washout phase followed by a 4-week treatment phase and concluded with a 4-week no treatment follow-up phase. During the 1-week washout phase, the patients refrained from using any medicated topical products to treat their facial acne vulgaris except for a standard facial cleanser, Cetaphil[R] cleanser (Galderma, Arlington, TX). Patients also had to be off systemic antibiotics for 4 weeks and systemic retinoids for 6 months prior to the study. Patients were excluded from participation if they had previously received light therapy of any kind in the past.

[FIGURE 1 OMITTED]

During the 4-week treatment phase, patients were randomized to receive either a) two times per week therapy with the Blu-U or b) topical 1% clindamycin solution to be self-administered twice daily at home by the subject. For those receiving blue light therapy, each treatment consisted of 16 minutes and 40 seconds of light therapy (1000 seconds). In the follow-up phase, designed to evaluate the duration of effect for the therapies, patients again refrained from using any medications to treat their facial acne vulgaris while continuing to use the standard facial cleanser.

The status of each patient's facial acne vulgaris was evaluated periodically throughout the treatment and follow-up phases of this clinical trial. A blinded investigator evaluated the patient and performed acne vulgaris lesion counts, a global severity score analysis, and an overall improvement score. Adverse effects were to be noted and documented at all times during the time period of the clinical trial.

Results

Thirty-four patients signed an informed consent to participate in this clinical research investigation. Twenty-five completed the 4-week treatment phase (beginning with mild to moderate inflammatory acne vulgaris lesions) and 18 of these patients completed the 4-week follow-up phase (72%). Nine patients who signed an informed consent were not able to follow through with the 4-week treatment phase and were not included in the results of this study. The age range of the study participants was from 13 years of age to 55 years of age, with a mean age of 31.0 years. The study population of those finishing the 4-week treatment phase consisted of 22 females and 3 males. Sixteen of the patients were Caucasian, 7 were African-American, 1 was an American Indian, and 1 was of Chinese descent.

Thirteen of the patients evaluated were randomized to receive twice daily application of topical 1% clindamycin antibiotic solution; 12 of the patients were randomized to receive twice weekly blue light therapy. The number of non-inflammatory acne vulgaris lesions was evaluated at each visit and the number of inflammatory acne vulgaris lesions was evaluated at each study visit as well.