A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea - Tabular View

Tracking Information
First Received Date ^ICMJE	August 2, 2005
Last Updated Date	August 18, 2005
Start Date ^ICMJE	June 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: August 2, 2005)	Change in total inflammatory lesion count
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00126399 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 18, 2005)	Change from baseline in erythema scale scores change from baseline in the investigator's global assessment (IGA) score proportion of patients being clear or near-clear at endpoint
Original Secondary Outcome Measures ^ICMJE (submitted: August 2, 2005)	change from baseline in erythema scale scores change from baseline in the IGA score proportion of patients being clear or near-clear at endpoint

Descriptive Information
Brief Title ^ICMJE	A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea
Official Title ^ICMJE
Brief Summary	The objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline controlled-release capsules administered once daily for the treatment of rosacea compared with a placebo.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Rosacea
Intervention ^ICMJE	Drug: doxycycline
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	528
Completion Date	April 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	Main Inclusion Criteria: Healthy patients with rosacea Males and females ≥18 years of age 10 to 40 papules and pustules and ≤2 nodules Score of 2 to 4 on the IGA Presence of telangiectasia Moderate to severe erythema Main Exclusion Criteria: Use of topical acne treatments or topical or systemic antibiotics Use of systemic retinoids within 90 days of baseline Use of an investigational drug within 90 days of baseline Pregnant or nursing women Women of childbearing potential not using an adequate form of contraception Change in method of contraception within 4 months of baseline Known hypersensitivity to tetracyclines Surgeries that bypass or exclude the duodenum or achlorhydria
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00126399
Responsible Party
Study ID Numbers ^ICMJE	COL-101-ROSE-301+302
Study Sponsor ^ICMJE	CollaGenex Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	CollaGenex Pharmaceuticals
Verification Date	August 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP