Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo After 12 Weeks of Oracea® and MetroGel® 1%

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT01426269
First received: August 26, 2011
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea during long-term treatment with either Oracea® or placebo, after an initial 12-week regimen of Oracea® and MetroGel® 1%.


Condition Intervention Phase
Rosacea
Drug: Oral Doxycycline and Topical Metronidazole
Drug: Oral Doxycycline
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® Capsules Compared to Placebo After an Initial 12 Week Treatment Regimen With Oracea® and MetroGel® 1% in Adults With Rosacea

Resource links provided by NLM:


Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:
  • Percentage of subjects who relapse during phase 2 of the study [ Time Frame: Phase 2 (week 12 - week 52) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in inflammatory lesion counts [ Time Frame: Baseline - week 52 ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Baseline - week 52 ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events in each treatment arm.


Estimated Enrollment: 200
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects will receive placebo during phase 2 (week 12 - week 52)
Drug: Placebo
During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning
Other Name: Placebo
Oral Doxycycline and Topical Metronidazole
Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
Drug: Oral Doxycycline and Topical Metronidazole
During phase 1 (baseline - week 12): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area
Other Name: Oracea® (doxycycline, USP) Capsules 40 mg and MetroGel® (metronidazole gel), 1%
Active Comparator: Oral Doxycycline
Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during phase 2 (week 12 - week 52)
Drug: Oral Doxycycline
During phase 2 week 12 - week 52: Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning
Other Name: Oracea® (doxycycline, USP) Capsules 40 mg

Detailed Description:

Adult subjects with moderate to severe papulopustular rosacea will receive Oracea® and MetroGel® 1% once daily during phase 1 (baseline to week 12) of the study. Subjects will be eligible to enter phase 2 of the study based upon improvements in the Investigator's Global Assessment (IGA) score. During phase 2, subjects will receive either Oracea® or placebo once daily for up to an additional 40 weeks. Subjects who relapse during phase 2 will be discontinued from the study.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is male or female aged 18 to 80 years inclusive.
  • Subject with papulopustular rosacea (11 to 40 papules or pustules) and an IGA of moderate or severe.
  • For subjects using medications to treat a concurrent medical condition, type and dose must have been stable for at least 90 days prior to study entry.

Exclusion Criteria:

  • Female subjects who are pregnant, nursing or planning a pregnancy during the study.
  • Subject has any other active dermatological condition on the face that may interfere with the conduct of the study.
  • Subject uses or has recently used any medication which may interfere with the absorption, distribution, or elimination of study medications, or may interfere with the assessments of efficacy or safety of the study medications.
  • Subject has a known allergy to any of the components of the study products, and/or a known hypersensitivity to tetracyclines or metronidazole.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426269

Locations
United States, California
ATS Clinical Research
Santa Monica, California, United States, 90404
United States, Florida
Dadeland Dermatology
Coral Gables, Florida, United States, 33134
United States, Kentucky
Melissa L. F. Knuckles M.D., P.S.C.
Corbin, Kentucky, United States, 40701
Dermatology Specialists Research
Louisville, Kentucky, United States, 40202
Melissa L. F. Knuckles M.D., P.S.C.
Richmond, Kentucky, United States, 40475
United States, Maryland
The Maryland Laser, Skin, and Vein Institute, LLC
Hunt Valley, Maryland, United States, 21030
United States, Michigan
Grekin Skin Institute
Warren, Michigan, United States, 48088
United States, New York
Hilary Baldwin
Brooklyn, New York, United States, 11201
The Center for Dermatology at Linden Oaks
Rochester, New York, United States, 14625
United States, Ohio
Brodell Medical, Inc.
Warren, Ohio, United States, 44483
United States, Oregon
Center for Dermatology and Laser Surgery
Portland, Oregon, United States, 97225
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
  More Information

No publications provided

Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01426269     History of Changes
Other Study ID Numbers: US10183
Study First Received: August 26, 2011
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Doxycycline
Doxycycline hyclate
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 July 22, 2014