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

June 29, 2007
December 11, 2008
March 2007
December 2007   (final data collection date for primary outcome measure)
Change in total lesion count from Baseline at the study endpoint [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change in total lesion count from Baseline at the study endpoint [ Time Frame: 16 weeks ]
Complete list of historical versions of study NCT00495313 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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

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%

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%

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Rosacea
  • Drug: doxycycline
    COL-101, QD plus metronidazole
    Other Name: Vibramycin, 100 mg, QD plus metornidazole
  • Drug: doxycycline
    40 mg with metronidazole QD
    Other Name: Oracea® 40 mg plus metronidazole
  • Active Comparator: Cohort 1: doxycycline
    Vibramycin plus metronidazole
    Intervention: Drug: doxycycline
  • Active Comparator: Cohort 2
    Oracea® delayed release plus metronidazole
    Intervention: Drug: doxycycline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00495313
COL101-ROSE-401
No
C. Powala, VP, Drug Development & Regulatory Affairs, CollaGenex Pharmaceuticals
CollaGenex Pharmaceuticals
Not Provided
Study Chair: Christopher V Powala, JD CollaGenex Pharmaceuticals
CollaGenex Pharmaceuticals
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP