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Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens

This study has been completed.
Information provided by:
CollaGenex Pharmaceuticals Identifier:
First received: June 29, 2007
Last updated: December 11, 2008
Last verified: December 2008
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%

Condition Intervention Phase
Drug: doxycycline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by CollaGenex Pharmaceuticals:

Primary Outcome Measures:
  • Change in total lesion count from Baseline at the study endpoint [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 91
Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort 1: doxycycline
Vibramycin plus metronidazole
Drug: doxycycline
COL-101, QD plus metronidazole
Other Name: Vibramycin, 100 mg, QD plus metornidazole
Active Comparator: Cohort 2
Oracea® delayed release plus metronidazole
Drug: doxycycline
40 mg with metronidazole QD
Other Name: Oracea® 40 mg plus metronidazole

Detailed Description:
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%

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
Sponsors and Collaborators
CollaGenex Pharmaceuticals
Study Chair: Christopher V Powala, JD CollaGenex Pharmaceuticals
  More Information

Responsible Party: C. Powala, VP, Drug Development & Regulatory Affairs, CollaGenex Pharmaceuticals Identifier: NCT00495313     History of Changes
Other Study ID Numbers: COL101-ROSE-401
Study First Received: June 29, 2007
Last Updated: December 11, 2008

Keywords provided by CollaGenex Pharmaceuticals:

Additional relevant MeSH terms:
Skin Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents processed this record on May 22, 2017