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The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice daily applications. The study will also evaluate the safety of the study products using tolerance and adverse event data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD07223 1.5% gel | Experimental | 500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face |
|
| CD07223 0.5% gel | Experimental | 500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face |
|
| Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel | Active Comparator | 500 microliters of Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel on one half-face and 500 microliters of the Epiduo vehicle gel on the other half-face in the morning and in the afternoon, 500 microliters of Epiduo vehicle gel on both half-faces |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epiduo vehicle gel | Drug | 500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total acne lesion count | change in total number of acne lesion count from baseline to end of treatment | 6 weeks |
| Percent change of acne lesion count | Percent change of acne lesion count from baseline to end of treatment | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion counts- Inflammatory | change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject | 6 weeks |
| Lesion count- non-inflammatory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Graeber, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceuticals | Hot Springs | Arkansas | United States | |||
| Dermatology Specialist PSC |
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| CD07223 | Drug | 500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks |
|
| CD07223 | Drug | 500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks |
|
| Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel | Drug | 500 microliters Epiduo Gel on one of the half-face for the morning dose |
|
change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject
| 6 weeks |
| Lesion counts- Inflammatory | Percent change of acne lesion count from baseline at each evaluation visit | 6 weeks |
| Lesion count- non-inflammatory | Percent change of acne lesion count from baseline at each evaluation visit | 6 weeks |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| Grekin Skin Institute | Warren | Michigan | 48088 | United States |
| TKL Research | Rochelle Park | New Jersey | 07662 | United States |
| Piedmont Medical Research | Winston-Salem | North Carolina | 27103 | United States |
| Cetero | Fargo | North Dakota | 58104 | United States |
| Derm Research, Inc | Austin | Texas | 78759 | United States |
| J & S Studies | Bryan | Texas | 77845 | United States |
| Education and Research Foundation, Inc | Lynchburg | Virginia | 24501 | United States |
| 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 |
|---|---|
| D000068801 | Adapalene, Benzoyl Peroxide Drug Combination |
| D000068816 | Adapalene |
| D001585 | Benzoyl Peroxide |
| D005782 | Gels |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
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