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Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens

Primary Purpose

Rosacea

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
doxycycline
doxycycline
Sponsored by
CollaGenex Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rosacea focused on measuring Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Joel Schlessinger
  • James Del Rosso
  • Angela Moore
  • William Abramovits
  • Douglas Forsha
  • Bernard Goffe
  • William Werschler

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cohort 1: doxycycline

Cohort 2

Arm Description

Vibramycin plus metronidazole

Oracea® delayed release plus metronidazole

Outcomes

Primary Outcome Measures

Change in total lesion count from Baseline at the study endpoint

Secondary Outcome Measures

Change in Investigator's Global Assessment from Baseline at the study endpoint
Change in Clinician's Erythema Assessment score from Baseline at the study endpoint
Change in total lesion count (papules + pustules + nodules) from Baseline at each visit

Full Information

First Posted
June 29, 2007
Last Updated
December 11, 2008
Sponsor
CollaGenex Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00495313
Brief Title
Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens
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 Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CollaGenex Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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%
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%

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
Keywords
Rosacea

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: doxycycline
Arm Type
Active Comparator
Arm Description
Vibramycin plus metronidazole
Arm Title
Cohort 2
Arm Type
Active Comparator
Arm Description
Oracea® delayed release plus metronidazole
Intervention Type
Drug
Intervention Name(s)
doxycycline
Other Intervention Name(s)
Vibramycin, 100 mg, QD plus metornidazole
Intervention Description
COL-101, QD plus metronidazole
Intervention Type
Drug
Intervention Name(s)
doxycycline
Other Intervention Name(s)
Oracea® 40 mg plus metronidazole
Intervention Description
40 mg with metronidazole QD
Primary Outcome Measure Information:
Title
Change in total lesion count from Baseline at the study endpoint
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change in Investigator's Global Assessment from Baseline at the study endpoint
Time Frame
16 weeks
Title
Change in Clinician's Erythema Assessment score from Baseline at the study endpoint
Time Frame
16 weeks
Title
Change in total lesion count (papules + pustules + nodules) from Baseline at each visit
Time Frame
4 weeks, 8 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher V Powala, JD
Organizational Affiliation
CollaGenex Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Joel Schlessinger
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
James Del Rosso
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Angela Moore
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
William Abramovits
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Douglas Forsha
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Bernard Goffe
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
William Werschler
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

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Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens

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