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| Name | Class |
|---|---|
| Medicis Pharmaceutical Corporation | INDUSTRY |
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The purpose of this research study is to evaluate the effectiveness of two different types of topical acne medication. This study will help to determine if one combined medication results in better acne improvement than two separate medications for acne.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks |
|
| 2 | Active Comparator | Generic clindamycin 1% gel plus tretinoin 0.025% cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clindamycin phosphate 1.2% and tretinoin 0.025% | Drug | applied once daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne | Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count | Baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Feldman, MD, Ph.D | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences, Dermatology | Winston-Salem | North Carolina | 27157 | United States |
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Participants were recruited from IRB approved advertising and the Wake Forest University Health Sciences Dermatology Clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Ziana Gel | Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks |
| FG001 | Clindamycin Plus Tretinoin Applied Separately | Generic clindamycin 1% gel plus tretinoin 0.025% cream |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| clindamycin 1% gel | Drug | Topical clindamycin applied each morning for 12 weeks |
|
| tretinoin 0.025% cream | Drug | Tretinoin 0.025% cream each evening for 12 weeks |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ziana Gel | Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks |
| BG001 | Clindamycin Plus Tretinoin Applied Separately | Generic clindamycin 1% gel plus tretinoin 0.025% cream |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | 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 | Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne | Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap | All patients were analyzed up to end of treatment or last visit. | Posted | Median | Full Range | Percent of doses | 12 weeks |
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| Secondary | The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count | All patients were analyzed up to end of treatment or last visit. | Posted | Mean | 95% Confidence Interval | percentage of lesions | Baseline to 12 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 | Ziana Gel | Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks | 0 | 13 | 1 | 13 | ||
| EG001 | Clindamycin Plus Tretinoin Applied Separately | Generic clindamycin 1% gel plus tretinoin 0.025% cream | 0 | 13 | 0 | 13 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning sensation on facial skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Feldman, MD, PhD | Wake Forest University Health Sciences | 336-716-3775 | sfeldman@wfubmc.edu |
| 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 |
|---|---|
| C007084 | clindamycin phosphate |
| C117880 | clindamycin, tretinoin drug combination |
| D002981 | Clindamycin |
| D005782 | Gels |
| D014212 | Tretinoin |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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| >=65 years |
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| Male |
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