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

Not Applicable

Completed

• Conditions: Acne Vulgaris
• Interventions: Device: Acne Mask; Drug: 2.5% Benzoyl Peroxide Treatment

• Registration Number: NCT02698436
• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

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.

Study Timeline

• Study First Submitted: 2016-02-26
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-03-03
• Study Start: 2016-03-31
• Primary Completion: 2016-08-31
• Study Completion: 2016-08-31
• Results First Submitted: 2017-08-29
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-27
• Last Update Submitted: 2017-12-27
• Results First Posted: 2018-01-23
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acne Mask	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
2.5% Benzoyl Peroxide Treatment	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

Primary Outcome Measures

Name	Time	Method
Percent Change of Global Face Total Acne Lesion Count From Baseline	Baseline to 12 Weeks

Secondary Outcome Measures

Name	Time	Method
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1	Baseline to 1 Week
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2	Baseline to 2 Weeks
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4	Baseline to 4 Weeks
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8	Baseline to 8 Weeks
Acne Lesion Counts Total Global Face - Baseline	Baseline	Acne Lesion Count Total Global Face at Baseline
Acne Lesion Counts Total Global Face - Week 1	1 Week	Acne Lesion Count Total Global Face Week 1
Acne Lesion Counts Total Global Face - Week 2	2 Weeks	Acne Lesion Count Total Global Face Week 2
Acne Lesion Counts Total Global Face - Week 4	4 Weeks	Acne Lesion Count Total Global Face Week 4
Acne Lesion Counts Total Global Face - Week 8	8 Weeks	Acne Lesion Count Total Global Face Week 8
Acne Lesion Counts Total Global Face - Week 12	12 Weeks	Acne Lesion Count Total Global Face Week 12
Investigator Global Acne Assessment - Baseline	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.
Investigator Global Acne Assessment - Week 1	1 Week	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.
Investigator Global Acne Assessment - Week 2	2 Weeks	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.
Investigator Global Acne Assessment - Week 4	4 Weeks	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.
Investigator Global Acne Assessment - Week 8	8 Weeks	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.
Investigator Global Acne Assessment - Week 12	12 Weeks	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.

Trial Locations

Locations (2)

Academic Dermatology Associates; 🇺🇸 Albuquerque, New Mexico, United States

Thomas J. Stephens and Associates, Inc.; 🇺🇸 Richardson, Texas, United States