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Safety and efficacy study in patients with acne vulgaris
randomized, double-blind, placebo controlled, parallel-group, multiple-center study to evaluate the efficacy and safety of ADPS in the treatment of acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADPS topical product | Experimental | A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks |
|
| Placebo Control | Placebo Comparator | A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADPS topical product | Drug | topical product |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face | Baseline to week 12 (study day 84) | |
| Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face | Baseline to week 12 (study day 84) | |
| The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 on the Face. | Success was defined as an IGA score that was at least two grades less than the baseline assessment. | Baseline to Week 12 (study day 84) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catawba Research | http://catawbaresearch.com/contact/ | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | ADPS Topical Product | A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks ADPS topical product: topical product |
| FG001 | Placebo Control | A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks Placebo Control: topical product |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ADPS Topical Product | A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks ADPS topical product: topical product |
| BG001 | Placebo Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The analysis population used for demographics excluded some subjects in baseline/randomized population. |
| 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 From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face | The analysis population for efficacy excluded some subjects in baseline/randomized population. | Posted | Least Squares Mean | 95% Confidence Interval | percentage change in lesion counts | Baseline to week 12 (study day 84) |
|
1 year
An adverse event was defined as "Any untoward medical occurrence in a Subject or clinical-trial Subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment", not any untoward or unfavorable medical occurrence in a participant " temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research" as defined by clinicaltrials.gov.
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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 | ADPS Topical Product | A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks ADPS topical product: topical product |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spontaneous abortion | Product Issues | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Clinical Research | Taro Pharmaceuticals U.S.A., Inc. | 9143459001 | Businessdevelopment@taro.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2016 | Aug 21, 2018 | Prot_SAP_000.pdf |
| 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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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Placebo Control | Drug | topical product |
|
|
A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
Placebo Control: topical product
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | The analysis population used for demographics excluded some subjects in baseline/randomized population. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The analysis population used for demographics excluded some subjects in baseline/randomized population. | Count of Participants | Participants |
|
| Race (NIH/OMB) | The analysis population used for demographics excluded some subjects in baseline/randomized population. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | The analysis population used for demographics excluded some subjects in baseline/randomized population. | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| Primary | Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face | The analysis population for efficacy excluded some subjects in baseline/randomized population. | Posted | Least Squares Mean | 95% Confidence Interval | percentage change in lesion counts | Baseline to week 12 (study day 84) |
|
|
|
|
| Primary | The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 on the Face. | Success was defined as an IGA score that was at least two grades less than the baseline assessment. | The analysis population for efficacy excluded some subjects in baseline/randomized population. | Posted | Number | Percentage of subjects | Baseline to Week 12 (study day 84) |
|
|
|
|
| 0 |
| 146 |
| 0 |
| 146 |
| 2 |
| 146 |
| EG001 | Placebo Control | A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks Placebo Control: topical product | 0 | 141 | 1 | 141 | 3 | 141 |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|