Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens
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ClinicalTrials.gov Identifier: NCT00495313 |
Recruitment Status :
Completed
First Posted : July 3, 2007
Last Update Posted : December 16, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rosacea | Drug: doxycycline | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 91 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Supportive Care |
Official Title: | 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 |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | December 2007 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Cohort 1: doxycycline
Vibramycin plus metronidazole
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Drug: doxycycline
COL-101, QD plus metronidazole
Other Name: Vibramycin, 100 mg, QD plus metornidazole |
Active Comparator: Cohort 2
Oracea® delayed release plus metronidazole
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Drug: doxycycline
40 mg with metronidazole QD
Other Name: Oracea® 40 mg plus metronidazole |
- Change in total lesion count from Baseline at the study endpoint [ Time Frame: 16 weeks ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495313
United States, Nebraska | |
Joel Schlessinger | |
Omaha, Nebraska, United States, 68144 | |
United States, Nevada | |
James Del Rosso | |
Las Vegas, Nevada, United States, 89052 | |
United States, Texas | |
Angela Moore | |
Arlington, Texas, United States, 76011 | |
William Abramovits | |
Dallas, Texas, United States, 75230 | |
United States, Utah | |
Douglas Forsha | |
West Jordan, Utah, United States, 84088 | |
United States, Washington | |
Bernard Goffe | |
Seattle, Washington, United States, 98101 | |
William Werschler | |
Spokane, Washington, United States, 99204 |
Study Chair: | Christopher V Powala, JD | CollaGenex Pharmaceuticals |
Responsible Party: | C. Powala, VP, Drug Development & Regulatory Affairs, CollaGenex Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00495313 |
Other Study ID Numbers: |
COL101-ROSE-401 |
First Posted: | July 3, 2007 Key Record Dates |
Last Update Posted: | December 16, 2008 |
Last Verified: | December 2008 |
Rosacea |
Rosacea Skin Diseases Metronidazole Doxycycline Anti-Infective Agents |
Anti-Bacterial Agents Antiprotozoal Agents Antiparasitic Agents Antimalarials |