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Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens

This study has been completed.
Sponsor:
Information provided by:
CollaGenex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00495313
First received: June 29, 2007
Last updated: December 11, 2008
Last verified: December 2008
History of Changes
  Purpose

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
Rosacea
 Drug: doxycycline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Rosacea
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495313

Locations
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
Investigators
Study Chair: Christopher V Powala, JD CollaGenex Pharmaceuticals
  More Information

No publications provided

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

Keywords provided by CollaGenex Pharmaceuticals:
Rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Doxycycline
Doxycycline hyclate
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013