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

• ClinicalTrials.gov Identifier: NCT02698436
• Recruitment Status: Completed
• First Posted: March 3, 2016
• Results First Posted: January 23, 2018
• Last Update Posted: January 23, 2018
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Information provided by (Responsible Party): Johnson & Johnson Consumer and Personal Products Worldwide

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Device: Acne Mask; Drug: 2.5% Benzoyl Peroxide Treatment	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: March 31, 2016
• Actual Primary Completion Date: August 31, 2016
• Actual Study Completion Date: August 31, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	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; Other Name: Light-Therapy Acne Device
Active Comparator: 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	Drug: 2.5% Benzoyl Peroxide Treatment; The BPO treatment is applied twice daily, once in the morning and once in the evening; Other Name: BPO

Outcome Measures

Primary Outcome Measures :

1. Percent Change of Global Face Total Acne Lesion Count From Baseline [ Time Frame: Baseline to 12 Weeks ]

Secondary Outcome Measures :

1. Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1 [ Time Frame: Baseline to 1 Week ]
2. Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2 [ Time Frame: Baseline to 2 Weeks ]
3. Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4 [ Time Frame: Baseline to 4 Weeks ]
4. Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8 [ Time Frame: Baseline to 8 Weeks ]
5. Acne Lesion Counts Total Global Face - Baseline [ Time Frame: Baseline ]
   Acne Lesion Count Total Global Face at Baseline
6. Acne Lesion Counts Total Global Face - Week 1 [ Time Frame: 1 Week ]
   Acne Lesion Count Total Global Face Week 1
7. Acne Lesion Counts Total Global Face - Week 2 [ Time Frame: 2 Weeks ]
   Acne Lesion Count Total Global Face Week 2
8. Acne Lesion Counts Total Global Face - Week 4 [ Time Frame: 4 Weeks ]
   Acne Lesion Count Total Global Face Week 4
9. Acne Lesion Counts Total Global Face - Week 8 [ Time Frame: 8 Weeks ]
   Acne Lesion Count Total Global Face Week 8
10. Acne Lesion Counts Total Global Face - Week 12 [ Time Frame: 12 Weeks ]
    Acne Lesion Count Total Global Face Week 12
11. Investigator Global Acne Assessment - Baseline [ Time Frame: 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.
12. Investigator Global Acne Assessment - Week 1 [ Time Frame: 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.
13. Investigator Global Acne Assessment - Week 2 [ Time Frame: 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.
14. Investigator Global Acne Assessment - Week 4 [ Time Frame: 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.
15. Investigator Global Acne Assessment - Week 8 [ Time Frame: 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.
16. Investigator Global Acne Assessment - Week 12 [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 40 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, New Mexico

Academic Dermatology Associates

Albuquerque, New Mexico, United States, 87106

United States, Texas

Thomas J. Stephens and Associates, Inc.

Richardson, Texas, United States, 75081

Sponsors and Collaborators

Johnson & Johnson Consumer and Personal Products Worldwide

Investigators

• Principal Investigator: Alicia D Bucko, D.O.; Academic Dermatology Associates
• Principal Investigator: Lily Jiang, Ph.D.; Thomas J. Stephens and Associates, Inc.

More Information

Publications:

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.

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.

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.

• Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
• ClinicalTrials.gov Identifier: NCT02698436
• Other Study ID Numbers: CO-151211140520-SACT
• First Posted: March 3, 2016
• Results First Posted: January 23, 2018
• Last Update Posted: January 23, 2018
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Acne

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Benzoyl Peroxide; Dermatologic Agents