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
1 other identifier
interventional
91
1 country
7
Brief Summary
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%
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2007
Shorter than P25 for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 29, 2007
CompletedFirst Posted
Study publicly available on registry
July 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedDecember 16, 2008
December 1, 2008
9 months
June 29, 2007
December 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in total lesion count from Baseline at the study endpoint
16 weeks
Secondary Outcomes (3)
Change in Investigator's Global Assessment from Baseline at the study endpoint
16 weeks
Change in Clinician's Erythema Assessment score from Baseline at the study endpoint
16 weeks
Change in total lesion count (papules + pustules + nodules) from Baseline at each visit
4 weeks, 8 weeks, 12 weeks
Study Arms (2)
Cohort 1: doxycycline
ACTIVE COMPARATORVibramycin plus metronidazole
Cohort 2
ACTIVE COMPARATOROracea® delayed release plus metronidazole
Interventions
COL-101, QD plus metronidazole
Eligibility Criteria
You may qualify if:
- total lesions
- erythema
- telangiectasia
You may not qualify if:
- non-pregnant, non-lactating
- achlorhydric
- gastric by-pass surgery
- allergy to study medications
- drug/alcohol abuse
- use of proton pump inhibitors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Joel Schlessinger
Omaha, Nebraska, 68144, United States
James Del Rosso
Las Vegas, Nevada, 89052, United States
Angela Moore
Arlington, Texas, 76011, United States
William Abramovits
Dallas, Texas, 75230, United States
Douglas Forsha
West Jordan, Utah, 84088, United States
Bernard Goffe
Seattle, Washington, 98101, United States
William Werschler
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christopher V Powala, JD
CollaGenex Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 29, 2007
First Posted
July 3, 2007
Study Start
March 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
December 16, 2008
Record last verified: 2008-12