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

NCT ID: NCT02698436

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-08-31

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acne Mask

The light therapy acne device is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.

Other Names: Cleanser is marketed while the device is not marketed

Group Type: EXPERIMENTAL

Acne Mask

Intervention Type: DEVICE

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

2.5% Benzoyl Peroxide Treatment

Cleanser and 2.5% Benzoyl Peroxide Treatment Both the cleanser and the 2.5% Benzoyl Peroxide Treatment are applied twice daily, once in the morning and once in the evening.

Other names: Both products are marketed

Group Type: ACTIVE_COMPARATOR

2.5% Benzoyl Peroxide Treatment

Intervention Type: DRUG

The BPO treatment is applied twice daily, once in the morning and once in the evening

Interventions

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

Intervention Type: DEVICE

2.5% Benzoyl Peroxide Treatment

The BPO treatment is applied twice daily, once in the morning and once in the evening

Intervention Type: DRUG

Other Intervention Names

Light-Therapy Acne Device; BPO

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alicia D Bucko, D.O.

Role: PRINCIPAL_INVESTIGATOR

Academic Dermatology Associates

Lily Jiang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Thomas J. Stephens and Associates, Inc.

Locations

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Thomas J. Stephens and Associates, Inc.

Richardson, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12589953 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6730638 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19150294 (View on PubMed)

Other Identifiers

CO-151211140520-SACT

Identifier Type: -

Identifier Source: org_study_id