| June 29, 2007 |
| December 11, 2008 |
| March 2007 |
| December 2007 (final data collection date for primary outcome measure) |
| Change in total lesion count from Baseline at the study endpoint [ Time Frame: 16 weeks ] [ Designated as safety issue: No ] |
| Change in total lesion count from Baseline at the study endpoint [ Time Frame: 16 weeks ] |
| Complete list of historical versions of study NCT00495313 on ClinicalTrials.gov Archive Site |
- Change in Investigator's Global Assessment from Baseline at the study endpoint [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change in Clinician's Erythema Assessment score from Baseline at the study endpoint [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change in total lesion count (papules + pustules + nodules) from Baseline at each visit [ Time Frame: 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
|
- Change in Investigator’s Global Assessment from Baseline at the study endpoint [ Time Frame: 16 weeks ]
- Change in Clinician’s Erythema Assessment score from Baseline at the study endpoint [ Time Frame: 16 weeks ]
- Change in total lesion count (papules + pustules + nodules) from Baseline at each visit [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]
|
| |
| Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens |
| Determine the Effects of COL-101 Administered Once Daily With Metronidazole Topical Gel, 1% Versus Doxycycline Hyclate 100 mg Administered Once Daily With Metronidazole Topical Gel, 1% in Patients With Moderate to Severe Rosacea |
To compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1% |
Compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1% |
| Phase IV |
| Interventional |
| Supportive Care, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Rosacea |
| Drug: doxycycline |
- Active Comparator: Vibramycin plus metronidazole
- Active Comparator: Oracea® delayed release plus metronidazole
|
| |
| |
| Completed |
| 91 |
| December 2007 |
| December 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 8-40 total lesions
- erythema
- telangiectasia
Exclusion Criteria:
- non-pregnant, non-lactating
- achlorhydric
- gastric by-pass surgery
- allergy to study medications
- drug/alcohol abuse
- use of proton pump inhibitors
|
| Both |
| 18 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00495313 |
| C. Powala, VP, Drug Development & Regulatory Affairs, CollaGenex Pharmaceuticals |
| COL101-ROSE-401 |
| CollaGenex Pharmaceuticals |
|
| Study Chair: |
Christopher V Powala, JD |
CollaGenex Pharmaceuticals |
|
|
| CollaGenex Pharmaceuticals |
| December 2008 |
