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The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Generic | Active Comparator | treatment of acne for 12 weeks |
|
| Brand | Active Comparator | Treatment of acne for 12 weeks |
|
| Placebo | Placebo Comparator | Treatment if acne for 12 weeks as placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tretinoin microsphere 0.1% | Drug | Treatment of acne vulgaris |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Acne | Counting of acne lesions both inflammatory and non-inflammatory | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krunal Patel, MD | Moore Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moore Clinical Research | Land O' Lakes | Florida | 34628 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Generic | Tretinoin Microsphere Gel 0.1% |
| FG001 | Brand | Retin-A Micro 0.1% |
| FG002 | Placebo | Microsphere Gel no active |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Generic | Tretinoin Microsphere Gel 0.1% |
| BG001 | Brand | Retin-A Micro 0.1% |
| BG002 |
| 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 |
| 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 | Improvement in Acne | Counting of acne lesions both inflammatory and non-inflammatory | Posted | Mean | Standard Deviation | Percent change | 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 | Generic | Tretinoin Microsphere Gel 0.1% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Tretinoin produces irritation |
No unexpected problems.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| K.L. Spear M.D. | Spear Pharma | 239-433-3442 | spear@spearpharma.com |
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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 |
|---|---|
| D014212 | Tretinoin |
| ID | Term |
|---|---|
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 |
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| Brand Retin-A Micro tretinoin microsphere gel 0.1% |
| Drug |
Treatment of acne vulgaris |
|
|
| placebo microsphere gel | Drug | treatment of acne vulgaris |
|
| Placebo |
Microsphere Gel no active |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 205 |
| 26 |
| 205 |
| EG001 | Brand | Retin-A Micro 0.1% | 0 | 209 | 29 | 209 |
| EG002 | Placebo | Microsphere Gel no active | 0 | 66 | 10 | 66 |
|
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| 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 |