NCT02698436

A Study to Evaluate the Effectiveness and Tolerance of Two Acne Treatments on Subjects With Mild to Moderate Acne.

A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne Treatments on Subjects With Mild to Moderate Acne Vulgaris

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DEVICE	Acne Mask	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
DRUG	2.5% Benzoyl Peroxide Treatment	The BPO treatment is applied twice daily, once in the morning and once in the evening

Timeline

• Start date: 2016-03-31
• Primary completion: 2016-08-31
• Completion: 2016-08-31
• First posted: 2016-03-03
• Last updated: 2018-01-23
• Results posted: 2018-01-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study