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To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk
This is an open label pilot study to determine the safety and efficacy of Dapsone (Aczone) 7.5% gel applied daily to the trunk for acne. Subjects will apply Dapsone for 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapsone gel 7.5% | Experimental | Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapsone 7.5 % gel | Drug | Dapsone gel 7.5% applied once daily to truncal acne |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale | Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline | 16 Weeks | |
| The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline | 16 Weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leon H. Kircik, M.D. | DermResearch PLLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology and Laser Surgery | Sacramento | California | 95819 | United States | ||
| DermResearch, PLLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapsone Gel 7.5% | Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks. Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dapsone Gel 7.5% | Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks. Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne |
| 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 | Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale | Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe | Posted | Count of Participants | Participants | 16 weeks |
|
|
16 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 | Dapsone Gel 7.5% | Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks. Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infected abrasions of legs | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. McAllister | Skin Sciences, PLLC | 5024519000 | mmdermresearch@yahoo.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 | Jun 1, 2016 | Feb 6, 2019 | Prot_SAP_000.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 |
|---|---|
| D003622 | Dapsone |
| D005782 | Gels |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D003102 | Colloids |
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| The Percent Change in Total Lesion Count at Week 16 Compared to Baseline |
| 16 Weeks |
| Louisville |
| Kentucky |
| 40014 |
| United States |
| James Q. DelRosso DO, LLC | Las Vegas | Nevada | 89117 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline | Posted | Mean | Standard Deviation | percent change in lesion count | 16 Weeks |
|
|
|
| Secondary | The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline | Posted | Mean | Standard Deviation | percent change in lesion count | 16 Weeks |
|
|
|
| Secondary | The Percent Change in Total Lesion Count at Week 16 Compared to Baseline | Posted | Mean | Standard Deviation | percent change in lesion count | 16 Weeks |
|
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 3 |
| 20 |
| gum graft surgery | Surgical and medical procedures | Systematic Assessment |
|
| stye, right eye | Eye disorders | Systematic Assessment |
|
| sunburn arms/chest/back | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D045424 |
| Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |