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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change of Global Face Total Acne Lesion Count From Baseline | Baseline to 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alicia D Bucko, D.O. | Academic Dermatology Associates | Principal Investigator |
| Lily Jiang, Ph.D. | Thomas J. Stephens and Associates, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States | ||
| Thomas J. Stephens and Associates, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12589953 | Background | 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. | |
| 6730638 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acne Mask | Light therapy mask applied to the face once in the evening for a duration of 10 minutes |
| FG001 | Benzoyl Peroxide 2.5% | Apply test product to face once in the morning and once at night. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 2.5% Benzoyl Peroxide Treatment | Drug | The BPO treatment is applied twice daily, once in the morning and once in the evening |
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| 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 | Acne Lesion Count Total Global Face at Baseline | Baseline |
| Acne Lesion Counts Total Global Face - Week 1 | Acne Lesion Count Total Global Face Week 1 | 1 Week |
| Acne Lesion Counts Total Global Face - Week 2 | Acne Lesion Count Total Global Face Week 2 | 2 Weeks |
| Acne Lesion Counts Total Global Face - Week 4 | Acne Lesion Count Total Global Face Week 4 | 4 Weeks |
| Acne Lesion Counts Total Global Face - Week 8 | Acne Lesion Count Total Global Face Week 8 | 8 Weeks |
| Acne Lesion Counts Total Global Face - Week 12 | Acne Lesion Count Total Global Face Week 12 | 12 Weeks |
| Investigator Global Acne Assessment - 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 | 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 | 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 | 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 | 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 | 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 |
| Richardson |
| Texas |
| 75081 |
| United States |
| 19150294 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Acne Mask | Light therapy mask applied to the face once in the evening for a duration of 10 minutes |
| BG001 | 2.5% Benzoyl Peroxide Treatment | Applied BPO treatment once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change of Global Face Total Acne Lesion Count From Baseline | Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | 95% Confidence Interval | Percent change of acne lesion count | Baseline to 12 Weeks |
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| Secondary | Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1 | Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | 95% Confidence Interval | Percent change of acne lesion count | Baseline to 1 Week |
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| Secondary | Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2 | Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | 95% Confidence Interval | Percent change of acne lesion count | Baseline to 2 Weeks |
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| Secondary | Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4 | Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | 95% Confidence Interval | Percent change of acne lesion count | Baseline to 4 Weeks |
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| Secondary | Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8 | Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | 95% Confidence Interval | Percent change of acne lesion count | Baseline to 8 Weeks |
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| Secondary | Acne Lesion Counts Total Global Face - Baseline | Acne Lesion Count Total Global Face at Baseline | Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | Standard Deviation | Lesion Count | Baseline |
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| Secondary | Acne Lesion Counts Total Global Face - Week 1 | Acne Lesion Count Total Global Face Week 1 | Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | Standard Deviation | Lesion Count | 1 Week |
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| Secondary | Acne Lesion Counts Total Global Face - Week 2 | Acne Lesion Count Total Global Face Week 2 | Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | Standard Deviation | Lesion Count | 2 Weeks |
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| Secondary | Acne Lesion Counts Total Global Face - Week 4 | Acne Lesion Count Total Global Face Week 4 | Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | Standard Deviation | Lesion Count | 4 Weeks |
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| Secondary | Acne Lesion Counts Total Global Face - Week 8 | Acne Lesion Count Total Global Face Week 8 | Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | Standard Deviation | Lesion Count | 8 Weeks |
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| Secondary | Acne Lesion Counts Total Global Face - Week 12 | Acne Lesion Count Total Global Face Week 12 | Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | Standard Deviation | Lesion Count | 12 Weeks |
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| Secondary | Investigator Global Acne Assessment - 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.
| Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | Standard Deviation | Score on a scale | Baseline |
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| Secondary | Investigator Global Acne Assessment - Week 1 | 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.
| Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | Standard Deviation | Score on a scale | 1 Week |
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| Secondary | Investigator Global Acne Assessment - Week 2 | 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.
| Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | Standard Deviation | Score on a scale | 2 Weeks |
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| Secondary | Investigator Global Acne Assessment - Week 4 | 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.
| Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | Standard Deviation | Score on a scale | 4 Weeks |
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| Secondary | Investigator Global Acne Assessment - Week 8 | 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.
| Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | Standard Deviation | Score on a scale | 8 Weeks |
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| Secondary | Investigator Global Acne Assessment - Week 12 | 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.
| Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data. | Posted | Mean | Standard Deviation | Score on a scale | 12 Weeks |
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Adverse events were collected from the time the informed consent/assent was obtained through the subject's last study procedure/visit. Serious adverse events were also collected 30 calendar days beyond the subject's last procedure/visit and longer if study-related.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acne Mask | Light therapy mask applied to the face once in the evening for a duration of 10 minutes | 0 | 59 | 0 | 59 | 0 | 59 |
| EG001 | 2.5% Benzoyl Peroxide Treatment | Applied BPO treatment once daily | 0 | 58 | 0 | 58 | 0 | 58 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Fitzgerald | JNJWorldwide | +1 908-904-6235 | lfitzge6@its.jnj.com |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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