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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
Sponsor:
Information provided by:
CollaGenex Pharmaceuticals

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%

Condition or disease Intervention/treatment Phase
Rosacea Drug: doxycycline Phase 4

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%

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
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




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

Secondary Outcome Measures :
  1. Change in Investigator's Global Assessment from Baseline at the study endpoint [ Time Frame: 16 weeks ]
  2. Change in Clinician's Erythema Assessment score from Baseline at the study endpoint [ Time Frame: 16 weeks ]
  3. Change in total lesion count (papules + pustules + nodules) from Baseline at each visit [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

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
First Posted: July 3, 2007    Key Record Dates
Last Update Posted: December 16, 2008
Last Verified: December 2008

Keywords provided by CollaGenex Pharmaceuticals:
Rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Metronidazole
Doxycycline
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents
Antimalarials