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NCT00495313 Clinical Trial

Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens

Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00495313
Other study ID # COL101-ROSE-401
Secondary ID
Status Completed
Phase Phase 4
First received June 29, 2007
Last updated December 11, 2008
Start date March 2007
Est. completion date December 2007

Study information
Verified date December 2008
Source CollaGenex Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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%

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%

Recruitment information / eligibility
Status Completed
Enrollment 91
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• doxycycline
COL-101, QD plus metronidazole
• doxycycline
40 mg with metronidazole QD

Locations
Country Name City State
United States Angela Moore Arlington Texas
United States William Abramovits Dallas Texas
United States James Del Rosso Las Vegas Nevada
United States Joel Schlessinger Omaha Nebraska
United States Bernard Goffe Seattle Washington
United States William Werschler Spokane Washington
United States Douglas Forsha West Jordan Utah

Sponsors (1)
Lead Sponsor Collaborator
CollaGenex Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in total lesion count from Baseline at the study endpoint 16 weeks No
Secondary Change in Investigator's Global Assessment from Baseline at the study endpoint 16 weeks No
Secondary Change in Clinician's Erythema Assessment score from Baseline at the study endpoint 16 weeks No
Secondary Change in total lesion count (papules + pustules + nodules) from Baseline at each visit 4 weeks, 8 weeks, 12 weeks No
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