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| Name | Class |
|---|---|
| Medicis Pharmaceutical Corporation | INDUSTRY |
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The purpose of this study is to determine whether Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel are effective and safe in the treatment of papulopustular rosacea.
Currently, there is no known cure for rosacea. The most effective treatment is systemic antibiotics, particularly of the tetracycline family. Topical treatments include metronidazole, antibacterials such as erythromycin and clindamycin, sulfacetamide and benzoyl peroxide. Isotretinoin (Accutane) is also used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clindamycin/Tretinoin Gel | Experimental | Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, chin, cheeks) once daily at night for 12 weeks |
|
| Placebo gel | Placebo Comparator | Participants applied Placebo gel with no active medication on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel | Drug | Applied on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Number of Inflammatory Lesions From Baseline to Week 12 | The number of inflammatory lesions (papules and pustules) on the face were counted by a dermatologist at baseline and week 12 for each participant. Change in the number of inflammatory lesions is defined as week 12 values minus the baseline values of the participant. Last observation carried forward (LOCF) method was used for missing values. | Baseline, week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexa Kimball, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology - Stanford School of Medicine | Stanford | California | 94305 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15389184 | Background | Pelle MT, Crawford GH, James WD. Rosacea: II. Therapy. J Am Acad Dermatol. 2004 Oct;51(4):499-512; quiz 513-4. doi: 10.1016/j.jaad.2004.03.033. | |
| 15153893 | Background | Wilkin J, Dahl M, Detmar M, Drake L, Liang MH, Odom R, Powell F; National Rosacea Society Expert Committee. Standard grading system for rosacea: report of the National Rosacea Society Expert Committee on the classification and staging of rosacea. J Am Acad Dermatol. 2004 Jun;50(6):907-12. doi: 10.1016/j.jaad.2004.01.048. No abstract available. |
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Some subjects required a wash-out of medications they were using. Subjects were excluded if they did not have enough lesions.
Subjects were recruited at MGH and Stanford University Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clindamycin/Tretinoin Gel | Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks |
| FG001 | Placebo Gel | Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clindamycin/Tretinoin Gel | Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks |
| BG001 | Placebo Gel |
| 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 | Mean Change in Number of Inflammatory Lesions From Baseline to Week 12 | The number of inflammatory lesions (papules and pustules) on the face were counted by a dermatologist at baseline and week 12 for each participant. Change in the number of inflammatory lesions is defined as week 12 values minus the baseline values of the participant. Last observation carried forward (LOCF) method was used for missing values. | Intent to treat (ITT) population. Participants who were randomized but only had baseline visit (never began treatment) were excluded from the analysis. Last observation carried forward (LOCF) was also used. | Posted | Mean | Standard Deviation | lesions | Baseline, week 12 |
|
12 weeks (duration of study participation)
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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 | Clindamycin/Tretinoin Gel | Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening rosacea | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
This study is limited by relatively small number of subjects. In addition, overall assessment of acne rosacea severity as determined by subjects' self-assessment was not performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexandra B. Kimball, MD | MGH CURTIS | 617-726-5066 | harvardskinstudies@partners.org |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C007084 | clindamycin phosphate |
| D014212 | Tretinoin |
| D005782 | Gels |
| C117880 | clindamycin, tretinoin drug combination |
| ID | Term |
|---|---|
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 |
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|
| Placebo gel | Drug | Applied placebo gel with no active medication to entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks |
|
|
| CURTIS - Massachussetts General Hospital |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| 11907512 | Background | Wilkin J, Dahl M, Detmar M, Drake L, Feinstein A, Odom R, Powell F. Standard classification of rosacea: Report of the National Rosacea Society Expert Committee on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2002 Apr;46(4):584-7. doi: 10.1067/mjd.2002.120625. No abstract available. |
| 8425809 | Background | Wilkin JK, DeWitt S. Treatment of rosacea: topical clindamycin versus oral tetracycline. Int J Dermatol. 1993 Jan;32(1):65-7. doi: 10.1111/j.1365-4362.1993.tb00974.x. |
| 10617662 | Background | Diaz BV, Lenoir MC, Ladoux A, Frelin C, Demarchez M, Michel S. Regulation of vascular endothelial growth factor expression in human keratinocytes by retinoids. J Biol Chem. 2000 Jan 7;275(1):642-50. doi: 10.1074/jbc.275.1.642. |
| 22395584 | Derived | Chang AL, Alora-Palli M, Lima XT, Chang TC, Cheng C, Chung CM, Amir O, Kimball AB. A randomized, double-blind, placebo-controlled, pilot study to assess the efficacy and safety of clindamycin 1.2% and tretinoin 0.025% combination gel for the treatment of acne rosacea over 12 weeks. J Drugs Dermatol. 2012 Mar;11(3):333-9. |
| Lost to Follow-up |
|
Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
| BG002 | 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 |
|
| OG001 | Placebo | Participants applied placebo gel without active ingredient on entire face (forehead, nose, cheek, chin)once daily at night for 12 weeks |
|
|
|
| 0 |
| 43 |
| 29 |
| 41 |
| EG001 | Placebo Gel | Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks | 0 | 40 | 11 | 39 |
| Facial scaling | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Facial Dryness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Facial redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Facial burning sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Facial itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Facial irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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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 |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |