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The purpose of this study is to evaluate the efficacy of 2 acne treatments for 24 weeks of use in adult men and women with mild to moderate facial acne, at least 5 inflammatory lesions, and at least 10 - 100 non-inflammatory lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product A (adapalene) | Active Comparator | Product A applied topically to the entire face or other affected area of the skin once daily |
|
| Product B (salicylic acid) | Active Comparator | Product B applied topically to the affected area of the skin 1 to 3 times daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Product A | Drug | Product A applied topically to the entire face or other affected area of the skin once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Total Lesions at Week 12 | Percent change from baseline in total lesions at week 12 was assessed by investigator or designee. Investigator or designee counted and recorded the number of open comedones, closed comedones, papules, and pustules on each subject's face. Lesions were counted globally on the following facial locations/quadrants: forehead, left cheek, chin, and right cheek. Each of the following lesion types were analyzed separately for forehead, left cheek, chin, right cheek, and the total of the 4 areas:
| Baseline and 12 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephens & Associates, Inc. Texas Research Center | Richardson | Texas | 75081 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adapalene | Subjects who were randomized to adapalene and used it once-daily. |
| FG001 | Salicylic Acid | Subjects who were randomized to salicylic acid and used it as directed per the OTC monograph. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adapalene | Subjects who were randomized to adapalene |
| BG001 | Salicylic Acid | Subjects who were randomized to salicylic acid. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed. |
| 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 in Total Lesions at Week 12 | Percent change from baseline in total lesions at week 12 was assessed by investigator or designee. Investigator or designee counted and recorded the number of open comedones, closed comedones, papules, and pustules on each subject's face. Lesions were counted globally on the following facial locations/quadrants: forehead, left cheek, chin, and right cheek. Each of the following lesion types were analyzed separately for forehead, left cheek, chin, right cheek, and the total of the 4 areas:
| A total of 127 were enrolled, but only 117 were included in the efficacy analysis. | Posted | Mean | Standard Deviation | Percent change in lesions | Baseline and 12 weeks |
|
Collected over the duration of the study up to 24 weeks.
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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 | Adapalene | Subjects who were randomized to adapalene | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Medical Affairs and Clinical Development | Galderma | 8179615325 | matthew.meckfessel@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 16, 2016 | Dec 9, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2016 | Dec 9, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 20, 2016 | Dec 9, 2022 | ICF_002.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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| ID | Term |
|---|---|
| D000068816 | Adapalene |
| D020156 | Salicylic Acid |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Product B | Drug | Product B applied topically to affected area of the skin 1 to 3 times daily |
|
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects treated with adapalene. |
| OG001 | Salicylic Acid | Subjects treated with salicylic acid. |
|
|
| 62 |
| 0 |
| 62 |
| 2 |
| 62 |
| EG001 | Salicylic Acid | Subjects who were randomized to salicylic acid. | 0 | 65 | 0 | 65 | 0 | 65 |
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| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D010636 | Phenols |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|