Clinical trial NCT02698436: A Study to Evaluate the Effectiveness and Tolerance of Two Acne Treatments on Subjects With Mild to Moderate Acne.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Keywords: Acne
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2016-03-03
Enrollment: 103
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Has mild to moderate acne
* Has 10 - 100 pimples, 10 - 50 inflamed red pimples, up to 2 raised bumps and no cysts
* In general good health
* Must avoid excessive sun exposure and any light treatments or any professional or aesthetic spa-like procedures
* Must not be pregnant, nursing or intend to become pregnant during the study
* Must agree to practice a medically acceptable form of birth control.
* Must be able to read, speak, write and understand English

Exclusion Criteria:

* Allergies or sensitivities to product ingredients or to light
* Has severe acne or pre-existing dermatological facial condition
* Has an uncontrolled disease or immune deficient disorder
* Is pregnant, breast-feeding or intending to become pregnant
* Has been taking prescription drug medication for acne or antibiotics for the past 6 months

Primary outcomes:
measure: Percent Change of Global Face Total Acne Lesion Count From Baseline
timeFrame: Baseline to 12 Weeks
Secondary outcomes:
measure: Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1
timeFrame: Baseline to 1 Week
measure: Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2
timeFrame: Baseline to 2 Weeks
measure: Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4
timeFrame: Baseline to 4 Weeks
measure: Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8
timeFrame: Baseline to 8 Weeks
measure: Acne Lesion Counts Total Global Face - Baseline
timeFrame: Baseline
measure: Acne Lesion Counts Total Global Face - Week 1
timeFrame: 1 Week
measure: Acne Lesion Counts Total Global Face - Week 2
timeFrame: 2 Weeks
measure: Acne Lesion Counts Total Global Face - Week 4
timeFrame: 4 Weeks
measure: Acne Lesion Counts Total Global Face - Week 8
timeFrame: 8 Weeks
measure: Acne Lesion Counts Total Global Face - Week 12
timeFrame: 12 Weeks
measure: Investigator Global Acne Assessment - Baseline
timeFrame: Baseline
measure: Investigator Global Acne Assessment - Week 1
timeFrame: 1 Week
measure: Investigator Global Acne Assessment - Week 2
timeFrame: 2 Weeks
measure: Investigator Global Acne Assessment - Week 4
timeFrame: 4 Weeks
measure: Investigator Global Acne Assessment - Week 8
timeFrame: 8 Weeks
measure: Investigator Global Acne Assessment - Week 12
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Richardson
country: United States
facility: Thomas J. Stephens and Associates, Inc.
state: Texas
Study officials:
affiliation: Academic Dermatology Associates
name: Alicia D Bucko, D.O.
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas J. Stephens and Associates, Inc.
name: Lily Jiang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ashkenazi H, Malik Z, Harth Y, Nitzan Y. Eradication of Propionibacterium acnes by its endogenic porphyrins after illumination with high intensity blue light. FEMS Immunol Med Microbiol. 2003 Jan 21;35(1):17-24. doi: 10.1111/j.1574-695X.2003.tb00644.x.
citation: Kjeldstad B. Photoinactivation of Propionibacterium acnes by near-ultraviolet light. Z Naturforsch C Biosci. 1984 Mar-Apr;39(3-4):300-2. doi: 10.1515/znc-1984-3-417.
citation: Barolet D. Light-emitting diodes (LEDs) in dermatology. Semin Cutan Med Surg. 2008 Dec;27(4):227-38. doi: 10.1016/j.sder.2008.08.003.