- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02698436
A Study to Evaluate the Effectiveness and Tolerance of Two Acne Treatments on Subjects With Mild to Moderate Acne. (TIGER)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87106
- Academic Dermatology Associates
-
-
Texas
-
Richardson, Texas, United States, 75081
- Thomas J. Stephens and Associates, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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 |
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 Names:
|
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 |
The BPO treatment is applied twice daily, once in the morning and once in the evening
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent Change of Global Face Total Acne Lesion Count From Baseline
Time Frame: Baseline to 12 Weeks
|
Baseline to 12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1
Time Frame: Baseline to 1 Week
|
Baseline to 1 Week
|
|
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2
Time Frame: Baseline to 2 Weeks
|
Baseline to 2 Weeks
|
|
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4
Time Frame: Baseline to 4 Weeks
|
Baseline to 4 Weeks
|
|
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8
Time Frame: Baseline to 8 Weeks
|
Baseline to 8 Weeks
|
|
Acne Lesion Counts Total Global Face - Baseline
Time Frame: Baseline
|
Acne Lesion Count Total Global Face at Baseline
|
Baseline
|
Acne Lesion Counts Total Global Face - Week 1
Time Frame: 1 Week
|
Acne Lesion Count Total Global Face Week 1
|
1 Week
|
Acne Lesion Counts Total Global Face - Week 2
Time Frame: 2 Weeks
|
Acne Lesion Count Total Global Face Week 2
|
2 Weeks
|
Acne Lesion Counts Total Global Face - Week 4
Time Frame: 4 Weeks
|
Acne Lesion Count Total Global Face Week 4
|
4 Weeks
|
Acne Lesion Counts Total Global Face - Week 8
Time Frame: 8 Weeks
|
Acne Lesion Count Total Global Face Week 8
|
8 Weeks
|
Acne Lesion Counts Total Global Face - Week 12
Time Frame: 12 Weeks
|
Acne Lesion Count Total Global Face Week 12
|
12 Weeks
|
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.
|
Baseline
|
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 Week
|
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.
|
2 Weeks
|
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.
|
4 Weeks
|
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.
|
8 Weeks
|
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.
|
12 Weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alicia D Bucko, D.O., Academic Dermatology Associates
- Principal Investigator: Lily Jiang, Ph.D., Thomas J. Stephens and Associates, Inc.
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CO-151211140520-SACT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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