Efficacy and Tolerability of a Combined 445nm and 630nm Over-the-counter Light Therapy Mask with and without Topical Salicylic Acid versus Topical Benzoyl Peroxide for the Treatment of Mild-to-moderate Acne Vulgaris

Abstract

Objective: To evaluate the efficacy and tolerance of a combined 445nm/630nm light therapy mask for the treatment of mild-to-moderate acne vulgaris with and without topical 1% salicylic acid with retinol versus 2.5% benzoyl peroxide.

Design: A 12-week evaluator-blinded, randomized study. Subjects were randomized to be treated with the 445nm/630nm light therapy mask alone, benzoyl peroxide, or 445nm/630nm light therapy mask with topical 1% salicylic acid with retinol.

Participants: Healthy male and female subjects 12 to 35 years old with Fitzpatrick skin types I to VI and mild-to-moderate facial acne vulgaris.

Measurements: The primary endpoint was the change in the number of inflammatory acne lesions after 12 weeks of treatment. Secondary endpoints included the change in noninflammatory acne lesions, change in total acne lesions, change in Investigator Global Acne Assessments, and overall responder rate.

Results: 445nm/630nm light therapy mask-treated subjects showed a 24.4-percent improvement in inflammatory acne lesions (p<0.01) versus 17.2 percent (p<0.05) and 22.7 percent (p<0.01) in benzoyl peroxide and 445nm/630nm light therapy mask with topical 1% salicylic acid with retinol, respectively, a 19.5-percent improvement in noninflammatory lesions (p<0.001) versus 6.3 and 4.8 percent for benzoyl peroxide and 445nm/630nm light therapy mask with topical 1% salicylic acid with retinol, respectively. Subjects in the 445nm/630nm light therapy mask group also achieved a 19.0-percent improvement in the Investigator Global Acne Assessment (p<0.001) versus 4.7 percent in benzoyl peroxide and 13.9 percent in 445nm/630nm light therapy mask with topical 1% salicylic acid with retinol (p<0.01). Treatments were well-tolerated overall with trends toward less early irritation in the 445nm/630nm light therapy mask group.

Conclusion: 445nm/630nm light therapy mask appears to be a safe and effective therapy for mild-to-moderate acne.

Figure 1.

Change in inflammatory acne lesions. MASK=Skin cleanser and the light mask treatment; BPO=Skin cleanser and 2.5% benzoyl peroxide lotion; MASK-SA=Skin cleanser and 1% salicylic acid + retinol and light mask treatment. MASK-treated subjects achieved 24.4% improvement in inflammatory skin lesions at Week 12. ^* denotes p=0.05, ^** denotes p=0.01, ^*** denotes p=0.001

Figure 2.

Change in noninflammatory acne lesions. MASK:=Skin cleanser and the light mask treatment; BPO=Skin cleanser and 2.5% benzoyl peroxide lotion; MASK-SA=Skin cleanser and 1% salicylic acid + retinol and light mask treatment. MASK-treated subjects in Group A achieved significant improvements in noninflammatory acne lesions (19.5%). ^*** denotes p=0.001

Figure 3.

Change in total acne lesions. MASK=Skin cleanser and the light mask treatment; BPO=Skin cleanser and 2.5% benzoyl peroxide lotion; MASK-SA=Skin cleanser and 1% salicylic acid + retinol and light mask treatment. MASK-treated subjects achieved a 22.8% improvement in total acne lesion counts. ^* denotes p=0.05, ^** denotes p=0.01, ^*** denotes p=0.001

Figure 4.

Change in Investigator Global Acne Assessment. MASK=Skin cleanser and the light mask treatment; BPO=Skin cleanser and 2.5% benzoyl peroxide lotion; MASK-SA=Skin cleanser and 1% salicylic acid + retinol and light mask treatment. MASK-treated subjects achieved a 19.0% improvement in change in Investigator Global Acne Assessment scores. ^* denotes p=0.05, ^** denotes p=0.01, ^*** denotes p=0.001

Figure 5.

Responder analysis. MASK=Skin cleanser and the light mask treatment; BPO=Skin cleanser and 2.5% benzoyl peroxide lotion; MASK-SA=Skin cleanser and 1% salicylic acid + retinol and light mask treatment. Responders were subjects with improvements in two of three primary endpoints of IGA, inflammatory, or noninflammatory lesions at Week 12. Full Responders were subjects withimprovements in all three primary endpoints at Week 12.