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Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens

Sponsor
CollaGenex Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00495313
Collaborator
(none)
91
Enrollment
7
Locations
2
Arms
9
Duration (Months)
13
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 :
Mar 1, 2007
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cohort 1: doxycycline

Vibramycin plus metronidazole

Drug: doxycycline
COL-101, QD plus metronidazole
Other Names:
  • Vibramycin, 100 mg, QD plus metornidazole

    		•
    Active Comparator: Cohort 2

    Oracea® delayed release plus metronidazole

    Drug: doxycycline
    40 mg with metronidazole QD
    Other Names:
  • Oracea® 40 mg plus metronidazole

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in total lesion count from Baseline at the study endpoint [16 weeks]

    Secondary Outcome Measures

    1. Change in Investigator's Global Assessment from Baseline at the study endpoint [16 weeks]

    2. Change in Clinician's Erythema Assessment score from Baseline at the study endpoint [16 weeks]

    3. Change in total lesion count (papules + pustules + nodules) from Baseline at each visit [4 weeks, 8 weeks, 12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 Joel Schlessinger Omaha Nebraska United States 68144
    2 James Del Rosso Las Vegas Nevada United States 89052
    3 Angela Moore Arlington Texas United States 76011
    4 William Abramovits Dallas Texas United States 75230
    5 Douglas Forsha West Jordan Utah United States 84088
    6 Bernard Goffe Seattle Washington United States 98101
    7 William Werschler Spokane Washington United States 99204

    Sponsors and Collaborators

    • CollaGenex Pharmaceuticals

    Investigators

    • Study Chair: Christopher V Powala, JD, CollaGenex Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00495313
    Other Study ID Numbers:
    • COL101-ROSE-401
    First Posted:
    Jul 3, 2007
    Last Update Posted:
    Dec 16, 2008
    Last Verified:
    Dec 1, 2008
    Keywords provided by , ,
    Rosacea
    Additional relevant MeSH terms:
    Rosacea
    Metronidazole
    Doxycycline

    Study Results

    No Results Posted as of Dec 16, 2008