Clinical TrialID 5313
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
NCT01659853
Erythema|Rosacea
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5313
- Evidence Id
- 5313
- Core Evidence Id
- 5313
- Source Clinical Trial Id
- 5298
- Herb2 Clinical Trial Id
- HBCT005298
- Nct Id
- NCT01659853
- Title
- Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
- Status
- Completed
- Phase
- Phase 3
- Study Result
- Yes
- Study Condition
- Erythema|Rosacea
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: CD07805/47 gel 0.5%/CD07805/47 Vehicle|DRUG: azelaic acid gel 15%
- Intervention Allocation
- Randomized
- Intervention Model
- Crossover
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 70
- Outcome Measure
- 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
- Sponsor Collaborator
- Galderma R&D
- Funded By
- INDUSTRY
- Location
- Hudson Dermatology, Evansville, Indiana, 47714, United States|Dermatology Specialists Research, LLC, Louisville, Kentucky, 40202, United States|DermResearch, Inc, Austin, Texas, 78759, United States|The Education & Research Foundation, Inc., Lynchburg, Virginia, 24501, United States
- Other Id
- US10219
- Start Date
- 2012-09
- Primary Completion Date
- 2012-12
- Completion Date
- 2012-12
- First Posted
- 2012-08-08
- Results First Posted
- 2014-07-10
- Last Update Posted
- 2022-08-25
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01659853
- Title Cn
- Title En
- Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
- Bilingual Status
- semi_complete