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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This study is being conducted to obtain safety, efficacy, and satisfaction data on the combination of topical Benzoyl Peroxide (BPO) 2.5% and the topical keratolytic agent Salicylic Acid (SA) 0.5% in the treatment of moderate to severe acne. Subjects with moderate or severe acne will be asked to apply the commercially available, over-the-counter products Foam Deep Cleanser (2.5% BPO), Foam Advanced Acne Treatment (2.5% BPO), and Foam Rejuvenating Toner (0.5% SA) daily for 12 weeks. No control group or reference treatment will be included.
This open-label, multicenter, study is being conducted to obtain safety, efficacy, and satisfaction data on an Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%), which includes Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Advanced Acne Treatment (2.5% Benzoyl Peroxide) and Foam Rejuvenating Toner (0.5% Salicylic Acid), in the treatment of moderate to severe acne. Approximately 120 male or female subjects ages 12-35 years, inclusive, with moderate or severe acne as assessed by Investigator's Global Assessment (ISGA) and lesion counts are expected to be enrolled. Subjects will be instructed to use all 3 study products as part of a complete acne treatment system; no reference therapy or control group will be included. Subjects will be instructed to apply Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Advnced Acne Treatment (2.5% Benzoyl Peroxide) to the face each morning and Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Rejuvenating Toner (0.5% Salicylic Acid) each evening over an application period of 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acne system - benzoyl peroxide 2.5%, Salicylic Acid 0.5% | Experimental | open label - no comparator; only Acne system - benzoyl peroxide 2.5%, Salicylic Acid 0.5% |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5% | Other | over the counter acne system |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit | The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extended from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. Mean percent change from baseline at each study visit was presented. | Baseline (Day 1) and Week 1, 2, 4, 8, 12 |
| Number of Participants With a Minimum 2-grade Improvement of Investigator's Static Global Assessment (ISGA) From Baseline to Each Study Visit | The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. | Baseline (Day 1) and Week 1, 2, 4, 8, 12 |
| Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit | The investigator assessed efficacy at baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit | The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extends from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fremont | California | 94538 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 115576 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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A total of 125 participants of 12 to 35 years from 9 centers in the United States were enrolled in this 12 Week study to evaluate the efficacy and safety of the MaxClarity System in participants with acne. The study started on 23 June 2011 and completed on 14 December 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | MaxClarity | Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (Benzoyl Peroxide[BPO]) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 percent salicylic acid [SA]) each evening over an application period of 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Week 1, 2, 4, 8 and 12 |
| Baseline (Day 1) and Week 1, 2, 4, 8, 12 |
| Mean Change in ISGA From Baseline to Each Study Visit | The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. | Baseline (Day 1) and Week 1, 2, 4, 8, 12 |
| Louisville |
| Kentucky |
| 40217 |
| United States |
| GSK Investigational Site | Rockville | Maryland | 20850 | United States |
| GSK Investigational Site | Belleville | New Jersey | 07109 | United States |
| GSK Investigational Site | Montclair | New Jersey | 07042 | United States |
| GSK Investigational Site | Stony Brook | New York | 11790 | United States |
| GSK Investigational Site | High Point | North Carolina | 27262 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37922 | United States |
| GSK Investigational Site | Austin | Texas | 78759 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| 115576 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115576 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115576 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115576 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115576 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115576 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MaxClarity | Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit | The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extended from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. Mean percent change from baseline at each study visit was presented. | Intent-to-treat (ITT) population consisted of all participants that were enrolled in the study. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Percent change in lesions | Baseline (Day 1) and Week 1, 2, 4, 8, 12 |
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| Primary | Number of Participants With a Minimum 2-grade Improvement of Investigator's Static Global Assessment (ISGA) From Baseline to Each Study Visit | The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. | ITT population. Only those participants with data available at that particular time points were analyzed. | Posted | Number | Participants | Baseline (Day 1) and Week 1, 2, 4, 8, 12 |
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| Primary | Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit | The investigator assessed efficacy at baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). | ITT population. | Posted | Number | Participants | Week 1, 2, 4, 8 and 12 |
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| Secondary | Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit | The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extends from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. | ITT population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles). | Posted | Mean | Standard Deviation | Lesions | Baseline (Day 1) and Week 1, 2, 4, 8, 12 |
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| Secondary | Mean Change in ISGA From Baseline to Each Study Visit | The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. | ITT population. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1) and Week 1, 2, 4, 8, 12 |
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Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
ITT population was used for all analyses which comprised of all participants enrolled in the study.
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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 | MaxClarity | Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks. | 0 | 125 | 0 | 125 | 12 | 125 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| SEASONAL ALLERGY | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| ORAL HERPES | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| POST PROCEDURAL INFECTION | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| VULVOVAGINAL MYCOTIC INFECTION | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| CONTUSION | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| BURNING SENSATION | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| OVARIAN CYST | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
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| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| 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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| Black |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| American Indian or Alaska Native/Asian |
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| American Indian or Alaska Native/Black |
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| Biracial |
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| IL Week 4 |
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| IL Week 8 |
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| IL Week 12 |
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| NIL Week 1 |
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| NIL Week 8 |
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| TL Week 4 |
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| TL Week 8 |
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| TL Week 12 |
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