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There are many different factors that cause acne. So combination treatment using different medications that can address these different factors is commonly used to treat acne. Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and benzoyl peroxide 6% foaming cloths are both used to treat acne. This study will evaluate the use of the medications when used together.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clindamycin phosphate 1.2%/tretinoin 0.025% gel alone | Active Comparator |
| |
| clindamycin / tretinoin gel plus benzoyl peroxide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clindamycin phosphate 1.2%/tretinoin 0.025% gel alone | Drug | Once daily application of the clindamycin phosphate 1.2%/tretinoin 0.025% gel in the evening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in PGA scores of patients using combination clindamycin phosphate 1.2%/tretinoin 0.025% gel with or without benzoyl peroxide 6% foaming cloths for facial acne | The primary efficacy endpoint will be "Treatment Success", a static endpoint defined as a score of 0 (clear) to 1 (almost clear) at Week 12 (final study visit) by PGA scoring system. | Weeks 2, 4, 8, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Postinflammatory hyperpigmentation score at each study visit and from baseline to final visit. | Change in PIH score from baseline will be assessed. (based on a 6 point scale) | Weeks 2, 4, 8, 12 |
| Total number of adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vicky Wong | Contact | 212-241-3288 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mt Sinai Hospital - Dept of Dermatology | Recruiting | New York | New York | 10029 | United States |
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| clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths | Drug | wash face with the benzoyl peroxide foaming cloth then rinse. then apply clindamycin phosphate 1.2%/tretinoin 0.025% gel. both done in the evening. |
|
Safety/drug-tolerance evaluated at each visit (total number of adverse events)
| Weeks 2, 4, 8, 12 |
| Change in Subject Self Assessment Scoring Scale | Patient rates current severity of their acne. | Weeks 2, 4, 8, 12 |
| Change in Acne-Specific Quality of Life Questionnaire (Acne-QoL) | Acne-QoL as completed by patient. | Weeks 2, 4, 8, 12 |
| 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 |
| D014212 | Tretinoin |
| D005782 | Gels |
| D001585 | Benzoyl Peroxide |
| ID | Term |
|---|---|
| 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 |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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