Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens - Full Text View

Sponsor:	CollaGenex Pharmaceuticals
Information provided by:	CollaGenex Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00495313

Purpose

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	Intervention	Phase
Rosacea	Drug: doxycycline	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Doxycycline Doxycycline hyclate Metronidazole hydrochloride Metronidazole phosphate Doxycycline calcium Metronidazole

U.S. FDA Resources

Further study details as provided by CollaGenex Pharmaceuticals:

Primary Outcome Measures:

Change in total lesion count from Baseline at the study endpoint [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	91
Study Start Date:	March 2007
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Cohort 1: doxycycline Vibramycin plus metronidazole	Drug: doxycycline COL-101, QD plus metronidazole Other Name: Vibramycin, 100 mg, QD plus metornidazole
Active Comparator: Cohort 2 Oracea® delayed release plus metronidazole	Drug: doxycycline 40 mg with metronidazole QD Other Name: Oracea® 40 mg plus metronidazole

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%

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495313

Locations

United States, Nebraska
Joel Schlessinger
Omaha, Nebraska, United States, 68144
United States, Nevada
James Del Rosso
Las Vegas, Nevada, United States, 89052
United States, Texas
Angela Moore
Arlington, Texas, United States, 76011
William Abramovits
Dallas, Texas, United States, 75230
United States, Utah
Douglas Forsha
West Jordan, Utah, United States, 84088
United States, Washington
Bernard Goffe
Seattle, Washington, United States, 98101
William Werschler
Spokane, Washington, United States, 99204

Sponsors and Collaborators

CollaGenex Pharmaceuticals

Investigators

Study Chair:

Christopher V Powala, JD

CollaGenex Pharmaceuticals

More Information

No publications provided

Responsible Party:	C. Powala, VP, Drug Development & Regulatory Affairs, CollaGenex Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00495313 History of Changes
Other Study ID Numbers:	COL101-ROSE-401
Study First Received:	June 29, 2007
Last Updated:	December 11, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by CollaGenex Pharmaceuticals:

Rosacea

Additional relevant MeSH terms:

Rosacea
Skin Diseases
Doxycycline hyclate
Doxycycline
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012