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

NCT02698436 | Completed Results DMC FDA Device

• 1 other identifier: CO-151211140520-SACT
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 2

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.

Conditions

Acne Vulgaris

Keywords

Acne

Outcome Measures

Primary Outcomes (1)

• Percent Change of Global Face Total Acne Lesion Count From Baseline

  Baseline to 12 Weeks

Secondary Outcomes (16)

• 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

Study Arms (2)

Acne Mask

EXPERIMENTAL

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

Device: Acne Mask

2.5% Benzoyl Peroxide Treatment

ACTIVE COMPARATOR

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

Drug: 2.5% Benzoyl Peroxide Treatment

Interventions

Acne Mask 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

Also known as: Light-Therapy Acne Device

Acne Mask

2.5% Benzoyl Peroxide Treatment DRUG

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

Also known as: BPO

2.5% Benzoyl Peroxide Treatment

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (2)

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Thomas J. Stephens and Associates, Inc.

Richardson, Texas, 75081, United States

Location

Related Publications (3)

• 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.

  PMID: 12589953 BACKGROUND

• 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.

  PMID: 6730638 BACKGROUND

• 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.

  PMID: 19150294 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Lisa Fitzgerald
• Organization: JNJWorldwide

lfitzge6@its.jnj.com

+1 908-904-6235

Study Officials

• Alicia D Bucko, D.O.

  Academic Dermatology Associates

  PRINCIPAL INVESTIGATOR

• Lily Jiang, Ph.D.

  Thomas J. Stephens and Associates, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 3, 2016
• Study Start: March 31, 2016
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: January 23, 2018
• Results First Posted: January 23, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)