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The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea.
Adult subjects with moderate to severe facial erythema of rosacea who meet inclusion/exclusion criteria will be randomized at Baseline/Visit 1 in a 1:1 ratio to receive either CD07805/47 gel 0.5% once daily or azelaic acid gel 15% twice daily for 15 days. Following an appropriate washout period, subjects will then switch treatments and use the second investigational product as instructed for 15 days (according to the subject's randomization scheme). Subjects will re-qualify based upon inclusion/exclusion prior to Period 2 treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall Study | Experimental | In this crossover study of CD07805/47 gel 0.5%/CD07805/47 Vehicle and azelaic acid gel 15%, 70 subjects were randomly assigned to treatment sequence. During Period 1 (15 days), 35 subjects received topical CD07805/47 gel 0.5% in the morning and topical CD07805/47 gel vehicle in the evening, and 35 received topical azelaic acid gel twice daily according to FDA approved prescribing information. Subjects crossed over to the other treatment in Period 2 (15 days). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD07805/47 gel 0.5%/CD07805/47 Vehicle | Drug | To maintain masking, CD07805/47 gel 0.5% will be administered along with CD07805/47 gel vehicle. During each treatment period (baseline to Day 15): CD07805/47 gel 0.5%, topical, once daily and CD07805/47 gel vehicle, topical, once daily |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Success | Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period | Hour 6 on Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of Action | Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application | 30 minutes after baseline treatment application on Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald W. Gottschalk, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hudson Dermatology | Evansville | Indiana | 47714 | United States | ||
| Dermatology Specialists Research, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | CD07805/47 Gel 0.5% and Vehicle, Then Azelaic Acid Gel 15% | Subjects were randomly assigned to treatment sequence. Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2. Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2. Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| azelaic acid gel 15% | Drug | During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily |
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| Louisville |
| Kentucky |
| 40202 |
| United States |
| DermResearch, Inc | Austin | Texas | 78759 | United States |
| The Education & Research Foundation, Inc. | Lynchburg | Virginia | 24501 | United States |
| FG001 | Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle | Subjects were randomly assigned to treatment sequence. Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2. Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2. Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information. |
| COMPLETED |
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| NOT COMPLETED |
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| Washout , 3 to 7 Days |
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| Treatment Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Participants were randomly assigned to treatment sequence. Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2. Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2. Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Fitzpatrick skin type | Fitzpatrick Skin Type Classification Scale I, always burns easily; never tans II, always burns easily; tans minimally and with difficulty III, burns minimally; tans gradually and uniformly (light brown) IV, burns minimally; always tans well (moderate brown) V, rarely burns; tans very easily (dark brown) VI, never burns, tans very easily (black) | Number | participants |
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| Skin type | 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 | Composite Success | Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period | A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed. | Posted | Number | percentage of subjects | Hour 6 on Day 15 |
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| Secondary | Onset of Action | Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application | A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed. All 70 enrolled subjects were analyzed for efficacy. | Posted | Number | percentage of subjects | 30 minutes after baseline treatment application on Day 15 |
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15 days
Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
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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 | CD07805/47 Gel 0.5 and Vehicle | Participants were randomly assigned to treatment sequence. Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2. Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2. Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information. | 0 | 70 | 19 | 70 | ||
| EG001 | Azelaic Acid 15% | Participants were randomly assigned to treatment sequence. Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2. Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2. Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information. | 0 | 68 | 27 | 68 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medication residue | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Skin discomfort | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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A significant period effect was observed for CEA indicating there was carryover from period 1 to period 2. Therefore, as stated a priori in the protocol, only data from period 1 were used to analyze efficacy. All safety data are reported.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Warren Winkelman | Galerma Laboratories | 817-961-5494 | warren.winkelman@galderma.com |
| ID | Term |
|---|---|
| D004890 | Erythema |
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| III |
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| IV |
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| V |
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| VI |
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| Oily |
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| Combination |
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| Participants |
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