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This study will compare two different acne treatment regimens for the treatment of acne. Half of participants will receive a cleanser and a light therapy mask, while half of the participants will receive a cleanser, a light therapy topical gel-cream, and a light therapy mask.
Acne vulgaris is a common chronic skin disease involving blockage and/or inflammation of the hair follicles and their accompany sebaceous glands.
Research has 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 acne-causing bacteria and have an effect on inflammation reduction.
Light-based therapies have been used successfully to treat dermatological conditions since the early 1900s, with various parts of the electromagnetic spectrum (i.e. ultraviolet [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 U.S. Food and Drug Administration (FDA) and has been approved for use in humans.
It is well established in the literature that visible light penetration into the epidermal and dermal layers of human skin is primarily governed by absorption and scattering events, with the latter being the more impactful of the two. Visible light penetration into human skin can be increased by reducing scattering. This can be accomplished by temporary hydrogen bonding disruption, which leads to the reversible rearrangement of epidermal and dermal structures that cause scattering. Glycerol (i.e. glycerin) is hypothesized to generate the level of hydrogen bonding disruption described above, and therefore will be investigated in the present study.
This study will look to evaluate and then compare the acne clearing efficacy and tolerance of two different acne treatment regimens - a cleanser used with a currently marketed red and blue light acne light therapy mask alone vs. the cleanser used with the same mask in conjunction with a light therapy topical gel-cream - to determine the efficacy of these treatments and then to assess if the efficacy of the light therapy mask used with the topical gel-cream treatment is non-inferior to the mask alone in the reduction of lesions in mild to moderate acne. If non-inferiority is demonstrated, the mask with topical gel-cream treatment will be further assessed for its superiority to the mask alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acne Mask | Active Comparator | Cleanser, Acne Mask |
|
| Gel-Cream + Acne Mask | Experimental | Cleanser, Gel-Cream, Acne Mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cleanser, Acne Mask | Device | A facial cleanser will be used twice daily (morning and evening). The light therapy mask will be used for 10 minutes in the evening after washing/drying the face. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Face Total Lesion Count - Percent Change - Baseline to Week 12 | Percent change from baseline in global face total lesion count at Week 12 | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Global Face Total Lesion Count - Percent Change - Baseline to Week 2 | Percent change from baseline in global face total lesion count at Week 2 | Baseline and Week 2 |
| Global Face Total Lesion Count - Percent Change - Baseline to Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alicia Bucko, D.O. | Academic Dermatology Associates | Principal Investigator |
| Lily Jiang, Ph.D. | Thomas J. Stephens & 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 | Gel-Cream + Acne Mask | Cleanser, Gel-Cream, Acne Mask |
| FG001 | Acne Mask | Cleanser, Acne Mask |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gel-Cream + Acne Mask | Cleanser, Gel-Cream, Acne Mask |
| BG001 | Acne Mask | Cleanser, Acne Mask |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Global Face Total Lesion Count - Percent Change - Baseline to Week 12 | Percent change from baseline in global face total lesion count at Week 12 | Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. There was no post-baseline data to carry forward for three subjects. | Posted | Mean | Standard Deviation | Percent Change in Lesions | Baseline and Week 12 |
|
Adverse events (AEs) were collected from time of informed consent through subject's last study procedure (Week 12 unless terminated early). Serious adverse events (SAE) reported to the site were also reportable within 30 days of last procedure/visit and longer if considered study-related; there was no specific cut-off date for this reporting, but AEs/SAEs are shown in this posting for a collection period of 1 year from last subject's visit (the time of this posting).
The Investigator or a designee interviewed subjects for changes in health/medication at each visit, documenting any reported adverse events.
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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 | Gel-Cream + Acne Mask | Cleanser, Gel-Cream, Acne Mask | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ali Fassih, Ph.D. | Johnson & Johnson Consumer Inc. | 908-904-3259 | Afassih@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 19, 2017 | Sep 4, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 6, 2017 | Sep 4, 2018 | Prot_001.pdf |
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| 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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Evaluator-blind
|
| Cleanser, Gel-Cream, Acne Mask | Device | A facial cleanser will be used twice daily (morning and evening). In the evening after cleansing, the gel-cream will be applied full face and allowed to dry before the light therapy mask is used for 10 minutes. |
|
|
Percent change from baseline in global face total lesion count at Week 4
| Baseline and Week 4 |
| Global Face Total Lesion Count - Percent Change - Baseline to Week 8 | Percent change from baseline in global face total lesion count at Week 8 | Baseline and Week 8 |
| Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits | Global face total lesion counts are averaged across all applicable post-baseline visits (Week 2, Week 4, Week 8, and Week 12). Percent change from baseline to the mean is then calculated. | Baseline to Week 2, Week 4, Week 8, and Week 12 |
| Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4 | Global face total lesion counts are averaged across Week 2 and Week 4. Percent change from baseline to the mean is then calculated. | Baseline to Week 2 and Week 4 |
| Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8 | Global face total lesion counts are averaged across Week 4 and Week 8. Percent change from baseline to the mean is then calculated. | Baseline to Week 4 and Week 8 |
| Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12 | Global face total lesion counts are averaged across Week 8 and Week 12. Percent change from baseline to the mean is then calculated. | Baseline to Week 8 and Week 12 |
| Global Face Open Comedones Count - Week 2 | Open comedones count on global face - Week 2 | 2 weeks |
| Global Face Open Comedones Count - Week 4 | Open comedones count on global face - Week 4 | 4 weeks |
| Global Face Open Comedones Count - Week 8 | Open comedones count on global face - Week 8 | 8 weeks |
| Global Face Open Comedones Count - Week 12 | Open comedones count on global face - Week 12 | 12 weeks |
| Global Face Closed Comedones Count - Week 2 | Closed comedones count on global face - Week 2 | 2 weeks |
| Global Face Closed Comedones Count - Week 4 | Closed comedones count on global face - Week 4 | 4 weeks |
| Global Face Closed Comedones Count - Week 8 | Closed comedones count on global face - Week 8 | 8 weeks |
| Global Face Closed Comedones Count - Week 12 | Closed comedones count on global face - Week 12 | 12 weeks |
| Global Face Inflammatory Lesion Count - Week 2 | Papules and pustules counted together | 2 weeks |
| Global Face Inflammatory Lesion Count - Week 4 | Papules and pustules counted together | 4 weeks |
| Global Face Inflammatory Lesion Count - Week 8 | Papules and pustules counted together | 8 weeks |
| Global Face Inflammatory Lesion Count - Week 12 | Papules and pustules counted together | 12 weeks |
| Global Face Non-Inflammatory Lesion Count - Week 2 | Sum of open comedones and closed comedones | 2 weeks |
| Global Face Non-Inflammatory Lesion Count - Week 4 | Sum of open comedones and closed comedones | 4 weeks |
| Global Face Non-Inflammatory Lesion Count - Week 8 | Sum of open comedones and closed comedones | 8 weeks |
| Global Face Non-Inflammatory Lesion Count - Week 12 | Sum of open comedones and closed comedones | 12 weeks |
| Global Face Total Lesion Count - Week 2 | Sum of inflammatory and non-inflammatory lesions | 2 weeks |
| Global Face Total Lesion Count - Week 4 | Sum of inflammatory and non-inflammatory lesions | 4 weeks |
| Global Face Total Lesion Count - Week 8 | Sum of inflammatory and non-inflammatory lesions | 8 weeks |
| Global Face Total Lesion Count - Week 12 | Sum of inflammatory and non-inflammatory lesions | 12 weeks |
| Investigator Global Acne Assessment - Week 1 | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 1. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. | 1 week |
| Investigator Global Acne Assessment - Week 2 | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 2. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. | 2 weeks |
| Investigator Global Acne Assessment - Week 4 | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 4. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. | 4 weeks |
| Investigator Global Acne Assessment - Week 8 | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 8. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. | 8 weeks |
| Investigator Global Acne Assessment - Week 12 | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 12. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. | 12 weeks |
| Overall Redness of Inflammatory Lesions - Week 1 | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness | 1 week |
| Overall Redness of Inflammatory Lesions - Week 2 | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness | 2 weeks |
| Overall Redness of Inflammatory Lesions - Week 4 | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness | 4 weeks |
| Overall Redness of Inflammatory Lesions - Week 8 | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness | 8 weeks |
| Overall Redness of Inflammatory Lesions - Week 12 | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness | 12 weeks |
| Overall Size of Inflammatory Lesions - Week 1 | Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large | 1 week |
| Overall Size of Inflammatory Lesions - Week 2 | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large | 2 weeks |
| Overall Size of Inflammatory Lesions - Week 4 | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large | 4 weeks |
| Overall Size of Inflammatory Lesions - Week 8 | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large. | 8 weeks |
| Overall Size of Inflammatory Lesions - Week 12 | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large | 12 weeks |
| Richardson |
| Texas |
| 75081 |
| United States |
| 15888126 | Background | Roelandts R. A new light on Niels Finsen, a century after his Nobel Prize. Photodermatol Photoimmunol Photomed. 2005 Jun;21(3):115-7. doi: 10.1111/j.1600-0781.2005.00160.x. No abstract available. |
| 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. |
| 17212549 | Background | Salomatina E, Jiang B, Novak J, Yaroslavsky AN. Optical properties of normal and cancerous human skin in the visible and near-infrared spectral range. J Biomed Opt. 2006 Nov-Dec;11(6):064026. doi: 10.1117/1.2398928. |
| Background | Bashkatov, AN, et al. Optical properties of melanin in the skin and skin-like phantoms. Proc. of SPIE, 4162: 219-226, 2000. |
| Background | Bashkatov, AN, et al. Optical properties of human skin, subcutaneous and mucous tissues in the wavelength range from 400 to 2000 nm. J Phys D: Appl Phys, 38: 2543-2555, 2005. |
| 23666068 | Background | Jacques SL. Optical properties of biological tissues: a review. Phys Med Biol. 2013 Jun 7;58(11):R37-61. doi: 10.1088/0031-9155/58/11/R37. Epub 2013 May 10. |
| 22741083 | Background | Lamouche G, Kennedy BF, Kennedy KM, Bisaillon CE, Curatolo A, Campbell G, Pazos V, Sampson DD. Review of tissue simulating phantoms with controllable optical, mechanical and structural properties for use in optical coherence tomography. Biomed Opt Express. 2012 Jun 1;3(6):1381-98. doi: 10.1364/BOE.3.001381. Epub 2012 May 15. |
| 16965130 | Background | Pogue BW, Patterson MS. Review of tissue simulating phantoms for optical spectroscopy, imaging and dosimetry. J Biomed Opt. 2006 Jul-Aug;11(4):041102. doi: 10.1117/1.2335429. |
| 17311267 | Background | Hirshburg J, Choi B, Nelson JS, Yeh AT. Correlation between collagen solubility and skin optical clearing using sugars. Lasers Surg Med. 2007 Feb;39(2):140-4. doi: 10.1002/lsm.20417. |
| Background | Wiegand, B, Luedtke, K, Rapp, SR. Acne Profile. Johnson & Johnson, One Johnson & Johnson Plaza, New Brunswick, NJ 08933-7003, assignee. Patent US 2006/0008484 A1. 12 Jan. 2006. Print. |
| Protocol Violation |
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| Adverse Event |
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| Non-Compliance with Study Treatment |
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| BG002 |
| Total |
Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Skin Sensitivity | Self-perceived skin sensitivity. Do you consider your skin to be sensitive...none of the time, some of the time, most of the time, all of the time | Count of Participants | Participants |
|
| Fitzpatrick Skin Type | Description:Measure of skin type characteristics, including sensitivity to burning/tanning. Ranging from I to VI, where I = White; very fair; red or blonde hair; blue eyes; freckles; Always burns easily; never tans and VI = Black; black hair, black eyes, black skin; Never burns; deeply pigmented | Count of Participants | Participants |
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| Secondary | Global Face Total Lesion Count - Percent Change - Baseline to Week 2 | Percent change from baseline in global face total lesion count at Week 2 | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Percent Change in Lesions | Baseline and Week 2 |
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| Secondary | Global Face Total Lesion Count - Percent Change - Baseline to Week 4 | Percent change from baseline in global face total lesion count at Week 4 | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Percent Change in Lesions | Baseline and Week 4 |
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| Secondary | Global Face Total Lesion Count - Percent Change - Baseline to Week 8 | Percent change from baseline in global face total lesion count at Week 8 | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Percent Change in Lesions | Baseline and Week 8 |
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| Secondary | Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits | Global face total lesion counts are averaged across all applicable post-baseline visits (Week 2, Week 4, Week 8, and Week 12). Percent change from baseline to the mean is then calculated. | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Percent Change in Lesions | Baseline to Week 2, Week 4, Week 8, and Week 12 |
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| Secondary | Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4 | Global face total lesion counts are averaged across Week 2 and Week 4. Percent change from baseline to the mean is then calculated. | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Percent Change in Lesions | Baseline to Week 2 and Week 4 |
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| Secondary | Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8 | Global face total lesion counts are averaged across Week 4 and Week 8. Percent change from baseline to the mean is then calculated. | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations | Posted | Mean | Standard Deviation | Percent Change in Lesions | Baseline to Week 4 and Week 8 |
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| Secondary | Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12 | Global face total lesion counts are averaged across Week 8 and Week 12. Percent change from baseline to the mean is then calculated. | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Percent Change in Lesions | Baseline to Week 8 and Week 12 |
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| Secondary | Global Face Open Comedones Count - Week 2 | Open comedones count on global face - Week 2 | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Open Comedones | 2 weeks |
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| Secondary | Global Face Open Comedones Count - Week 4 | Open comedones count on global face - Week 4 | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Open Comedones | 4 weeks |
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| Secondary | Global Face Open Comedones Count - Week 8 | Open comedones count on global face - Week 8 | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Open Comedones | 8 weeks |
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| Secondary | Global Face Open Comedones Count - Week 12 | Open comedones count on global face - Week 12 | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Open Comedones | 12 weeks |
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| Secondary | Global Face Closed Comedones Count - Week 2 | Closed comedones count on global face - Week 2 | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Closed Comedones | 2 weeks |
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| Secondary | Global Face Closed Comedones Count - Week 4 | Closed comedones count on global face - Week 4 | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Closed Comedones | 4 weeks |
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| Secondary | Global Face Closed Comedones Count - Week 8 | Closed comedones count on global face - Week 8 | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Closed Comedones | 8 weeks |
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| Secondary | Global Face Closed Comedones Count - Week 12 | Closed comedones count on global face - Week 12 | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Closed Comedones | 12 weeks |
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| Secondary | Global Face Inflammatory Lesion Count - Week 2 | Papules and pustules counted together | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Inflammatory Lesions | 2 weeks |
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| Secondary | Global Face Inflammatory Lesion Count - Week 4 | Papules and pustules counted together | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Inflammatory Lesions | 4 weeks |
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| Secondary | Global Face Inflammatory Lesion Count - Week 8 | Papules and pustules counted together | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Inflammatory Lesions | 8 weeks |
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| Secondary | Global Face Inflammatory Lesion Count - Week 12 | Papules and pustules counted together | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Inflammatory Lesions | 12 weeks |
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| Secondary | Global Face Non-Inflammatory Lesion Count - Week 2 | Sum of open comedones and closed comedones | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Non-inflammatory Lesions | 2 weeks |
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| Secondary | Global Face Non-Inflammatory Lesion Count - Week 4 | Sum of open comedones and closed comedones | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Non-inflammatory lesions | 4 weeks |
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| Secondary | Global Face Non-Inflammatory Lesion Count - Week 8 | Sum of open comedones and closed comedones | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Non-inflammatory Lesions | 8 weeks |
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| Secondary | Global Face Non-Inflammatory Lesion Count - Week 12 | Sum of open comedones and closed comedones | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Non-inflammatory Lesions | 12 weeks |
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| Secondary | Global Face Total Lesion Count - Week 2 | Sum of inflammatory and non-inflammatory lesions | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Lesions | 2 weeks |
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|
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| Secondary | Global Face Total Lesion Count - Week 4 | Sum of inflammatory and non-inflammatory lesions | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Lesions | 4 weeks |
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|
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| Secondary | Global Face Total Lesion Count - Week 8 | Sum of inflammatory and non-inflammatory lesions | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Lesions | 8 weeks |
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|
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| Secondary | Global Face Total Lesion Count - Week 12 | Sum of inflammatory and non-inflammatory lesions | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Lesions | 12 weeks |
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| Secondary | Investigator Global Acne Assessment - Week 1 | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 1. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 1 week |
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| Secondary | Investigator Global Acne Assessment - Week 2 | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 2. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 2 weeks |
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| Secondary | Investigator Global Acne Assessment - Week 4 | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 4. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
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| Secondary | Investigator Global Acne Assessment - Week 8 | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 8. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 8 weeks |
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| Secondary | Investigator Global Acne Assessment - Week 12 | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 12. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks |
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| Secondary | Overall Redness of Inflammatory Lesions - Week 1 | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 1 week |
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| Secondary | Overall Redness of Inflammatory Lesions - Week 2 | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 2 weeks |
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| Secondary | Overall Redness of Inflammatory Lesions - Week 4 | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
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| Secondary | Overall Redness of Inflammatory Lesions - Week 8 | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 8 weeks |
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| Secondary | Overall Redness of Inflammatory Lesions - Week 12 | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks |
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| Secondary | Overall Size of Inflammatory Lesions - Week 1 | Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 1 week |
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| Secondary | Overall Size of Inflammatory Lesions - Week 2 | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 2 weeks |
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| Secondary | Overall Size of Inflammatory Lesions - Week 4 | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
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| Secondary | Overall Size of Inflammatory Lesions - Week 8 | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large. | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 8 weeks |
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| Secondary | Overall Size of Inflammatory Lesions - Week 12 | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large | Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks |
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| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
| EG001 | Acne Mask | Cleanser, Acne Mask | 0 | 61 | 0 | 61 | 0 | 61 |
PI must provide Sponsor 60 days to review any publication (unless expedited review requested); if includes Sponsor's confidential info, written Sponsor approval is required. Sponsor may require another 60 days' delay to file patent app. If multicenter, PI agrees 1st publication is joint publication. If joint publication not submitted within 24 months of study end or Sponsor confirms there will be no joint publication, PI may publish the results individually following previous guidelines.