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| Sponsor: | Intendis GmbH |
|---|---|
| Information provided by: | Intendis GmbH |
| ClinicalTrials.gov Identifier: | NCT00855595 |
Purpose
Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg)daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.
| Condition | Intervention | Phase |
|---|---|---|
|
Papulopustular Rosacea |
Drug: azelaic acid gel plus 40 mg doxycycline Drug: metronidazole plus doxycycline |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | An Exploratory, Multicenter, Investigator-blinded, Active-controlled Study to Investigate the Efficacy of Topical Azelaic Acid (AzA)15% Gel Twice Daily or Metronidazole Topical Gel 1% Once Daily, Plus Anti-inflammatory Dose Doxycycline (40mg) Once Daily in Subjects With Moderate Papulopustular Rosacea |
| Enrollment: | 200 |
| Study Start Date: | February 2009 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: azelaic acid
topically
|
Drug: azelaic acid gel plus 40 mg doxycycline
azelaic acid gel 15% topically twice daily for 12 weeks and doxycycline 40 mg once daily for 12 weeks
Other Name: Finacea
|
|
Active Comparator: metronidazole
Metrogel
|
Drug: metronidazole plus doxycycline
topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
Other Name: Metrogel
|
The change in inflammatory lesion count will be assessed at each post-baseline visit by an analysis of variance model (ANOVA) with factors treatment and center, but not including treatment-by-center interaction.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Nevada | |
| James Del Rosso, MD | |
| Henderson, Nevada, United States, 89052 | |
| Principal Investigator: | James Del Rosso, MD | Private Practice in Henderson Nevada |
More Information
| Responsible Party: | Dr Allan Kayne, Intendis Inc. |
| ClinicalTrials.gov Identifier: | NCT00855595 History of Changes |
| Other Study ID Numbers: | 1402604, Project number: 256-0024 |
| Study First Received: | March 3, 2009 |
| Last Updated: | June 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
rosacea |
|
Rosacea Skin Diseases Anti-Inflammatory Agents Doxycycline Doxycycline hyclate Metronidazole Azelaic acid Therapeutic Uses Pharmacologic Actions |
Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Dermatologic Agents Antineoplastic Agents |