This study will compare two different acne treatments for the treatment of acne. Half of the participants will receive two marketed acne products (cleanser and leave-on topical treatment), while the other half of the participants will receive a marketed cleanser and a light-therapy device.
Acne is a common chronic skin disease involving blockage and/or inflammation of the hair follicles and their accompanying sebaceous gland. Benzoyl peroxide (BPO) is one of the most effective and well-studied over-the-counter (OTC) acne therapies, is generally regarded as safe and effective and is considered as a first-line treatment for acne. Topical BPO monotherapy products for at-home acne treatment have been available for OTC use for more than 30 years and studies have indicated that a low dose of BPO may be an effective approach for treating acne using an OTC product when applied consistently to larger areas of the face due primarily to its effects against acne-causing bacteria. BPO has anti-inflammatory and keratolytic properties, but is thought to act primarily to control P. acnes by releasing reactive oxygen species that are toxic to the bacteria. The most common side effect of topical BPO treatment is skin irritation, which can include erythema, burning, and peeling. As an alternative to topical OTC standard of care therapies, research has also shown the benefits of red and blue light therapy in the treatment of mild to moderate acne, with red and blue light shown to target the acne-causing bacteria and have an effect on inflammation reduction. Light-based therapies have been successfully used to treat dermatological conditions since the early 1900's, with various parts of the electromagnetic spectrum (i.e. UV, visible, near-Infrared, etc.) demonstrating different benefits. Light-emitting diodes (LEDs) offer delivery of light to the skin in a gentler manner as compared to light delivered by lasers primarily due to the lower energy output. It has been reported that LEDs do not deliver enough power to damage tissues and do not have the same risk of accidental eye damage that lasers do. Visible-LED light therapy has been deemed a non-significant risk by the Food and Drug Administration and has been approved for use in humans. This study will look to compare the acne clearing efficacy and tolerance of two different acne treatments: a currently marketed 2.5% BPO full-face topical OTC treatment, and an Investigational red and blue light acne light therapy mask, to determine if the acne resolution efficacy of the Investigational mask is as effective as a current OTC standard of care for at-home treatment of mild to moderate acne.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
103
The light therapy device contains a combination of red and blue light-emitting diodes. The device is applied once daily, in the evening for a duration of 10 minutes
The BPO treatment is applied twice daily, once in the morning and once in the evening
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Thomas J. Stephens and Associates, Inc.
Richardson, Texas, United States
Percent Change of Global Face Total Acne Lesion Count From Baseline
Time frame: Baseline to 12 Weeks
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1
Time frame: Baseline to 1 Week
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2
Time frame: Baseline to 2 Weeks
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4
Time frame: Baseline to 4 Weeks
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8
Time frame: Baseline to 8 Weeks
Acne Lesion Counts Total Global Face - Baseline
Acne Lesion Count Total Global Face at Baseline
Time frame: Baseline
Acne Lesion Counts Total Global Face - Week 1
Acne Lesion Count Total Global Face Week 1
Time frame: 1 Week
Acne Lesion Counts Total Global Face - Week 2
Acne Lesion Count Total Global Face Week 2
Time frame: 2 Weeks
Acne Lesion Counts Total Global Face - Week 4
Acne Lesion Count Total Global Face Week 4
Time frame: 4 Weeks
Acne Lesion Counts Total Global Face - Week 8
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Acne Lesion Count Total Global Face Week 8
Time frame: 8 Weeks
Acne Lesion Counts Total Global Face - Week 12
Acne Lesion Count Total Global Face Week 12
Time frame: 12 Weeks
Investigator Global Acne Assessment - Baseline
Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present. 1. Almost Clear. A few scattered comedones and a few (less than five) small papules. 2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules. 3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules. 4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts. 5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Time frame: Baseline
Investigator Global Acne Assessment - Week 1
Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present. 1. Almost Clear. A few scattered comedones and a few (less than five) small papules. 2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules. 3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules. 4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts. 5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Time frame: 1 Week
Investigator Global Acne Assessment - Week 2
Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present. 1. Almost Clear. A few scattered comedones and a few (less than five) small papules. 2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules. 3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules. 4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts. 5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Time frame: 2 Weeks
Investigator Global Acne Assessment - Week 4
Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present. 1. Almost Clear. A few scattered comedones and a few (less than five) small papules. 2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules. 3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules. 4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts. 5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Time frame: 4 Weeks
Investigator Global Acne Assessment - Week 8
Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present. 1. Almost Clear. A few scattered comedones and a few (less than five) small papules. 2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules. 3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules. 4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts. 5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Time frame: 8 Weeks
Investigator Global Acne Assessment - Week 12
Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present. 1. Almost Clear. A few scattered comedones and a few (less than five) small papules. 2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules. 3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules. 4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts. 5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Time frame: 12 Weeks