| January 22, 2008 |
| July 22, 2009 |
| January 2008 |
| May 2008 (final data collection date for primary outcome measure) |
- Nominal change in inflammatory lesion [ Time Frame: From baseline to the end of treatment ] [ Designated as safety issue: No ]
- Investigator's Global Assessment dichotomized into success and failure [ Time Frame: At the end of treatment ] [ Designated as safety issue: No ]
- Change in erythema rating on a four-point scale [ Time Frame: From baseline to the end of treatment ] [ Designated as safety issue: No ]
|
| Same as current |
| Complete list of historical versions of study NCT00617903 on ClinicalTrials.gov Archive Site |
- Absolute values and percentage change from baseline for the inflammatory lesion count [ Time Frame: From baseline to the end of treatment ] [ Designated as safety issue: No ]
- Absolute values and nominal change from baseline for the IGA of rosacea [ Time Frame: From baseline to the end of treatment ] [ Designated as safety issue: No ]
- Absolute values and rating changes of erythema and telangiectasia [ Time Frame: From baseline to the end of treatment ] [ Designated as safety issue: No ]
- Investigator's and patients' rating of overall improvement and the patients' opinion on cosmetic acceptability [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Exploratory Study of Azelaic Acid 15% Foam Compared to Vehicle in Patients With Papulopustular Rosacea |
| A 12-week Exploratory, Multicenter, Double-blind, Vehicle-controlled Study to Investigate the Efficacy and Safety of Topical Azelaic Acid 15% Foam Twice Daily in Patients With Papulopustular Rosacea |
This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Papulopustular Rosacea |
- Drug: Azelaic acid
- Drug: Vehicle
|
- Experimental: Azelaic acid 15% foam
- Placebo Comparator: Vehicle
|
| |
| |
| Completed |
| 84 |
| June 2008 |
| May 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules
- Ability and willingness to accept and comply with treatment and required medical examinations
Exclusion Criteria:
- Known non-responders to azelaic acid
- Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea
- Presence of dermatoses that could interfere with the rosacea diagnosis
- Treatment with isotretinoin in the six months prior to randomization
- Treatment of the face with topical retinoids during the two weeks prior to randomization
- Treatment with oral antibiotics during the four weeks prior to randomization
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00617903 |
| Dr Klaus Graupe, Intendis GmbH |
| 1402140, IND 77,516 |
| Intendis GmbH |
|
| Study Chair: |
Klaus Graupe, PhD |
Intendis GmbH |
|
|
| Intendis GmbH |
| July 2009 |
