Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT01426269
First received: August 26, 2011
Last updated: July 8, 2014
Last verified: July 2014
  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: Doxycycline
Drug: Metronidazole
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:
  • Period 2: Number of Subjects Who Relapsed [ Time Frame: Period 2 (40 weeks) ] [ Designated as safety issue: No ]

    Subjects who relapsed during phase 2 were discontinued. Relapse was defined as meeting any one of the following criteria:

    • A return to the baseline lesion count
    • A return to the baseline IGA score
    • The investigator determines that a change in rosacea treatment is warranted due to the subject's clinical condition. The numbers reported here are accumulative numbers for each arm.


Secondary Outcome Measures:
  • Period 2: Investigator's Global Assessment Success [ Time Frame: Period 2 (40 weeks) ] [ Designated as safety issue: No ]
    The evaluator (investigator) assessed the severity of rosacea at baseline and each postbaseline visit using a 5 point Investigator's Global Assessment scale. Subjects scores were then dichotomized into success (clear or near clear score) or failure (mild, moderate, or severe score).

  • Period 2: Clinician's Erythema Assessment [ Time Frame: Period 2 (40 Weeks) ] [ Designated as safety issue: No ]
    The evaluator (investigator) assessed the severity of erythema at baseline and each postbaseline visit using a total erythema score. The erythema of 5 areas of the face (forehead, chin, nose, right cheek, left cheek) was scored using a 5 point Clinician's Erythema Assessment scale (0 = none, 1 = mild, 2 = moderate, 3 = significant, 4 = severe). The total of the 5 individual erythema scores scores was the total erythema score.

  • Period 2: Inflammatory Lesion Count [ Time Frame: Period 2 (40 Weeks) ] [ Designated as safety issue: No ]
    The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit.


Other Outcome Measures:
  • Period 1: Tolerability (Scaling) [ Time Frame: Period 1 (12 Weeks) ] [ Designated as safety issue: No ]
    Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.

  • Period 1: Tolerability (Stinging/Burning) [ Time Frame: Period 1 (12 Weeks) ] [ Designated as safety issue: No ]
    Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.

  • Period 1: Tolerability (Dryness) [ Time Frame: Period 1 (12 Weeks) ] [ Designated as safety issue: No ]
    Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.


Enrollment: 235
Study Start Date: September 2011
Study Completion Date: June 2013
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
Doxycycline and 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: Doxycycline
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 During phase 1 (baseline - week 12) and 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® Capsules 40 mg
Drug: Metronidazole
During Phase 1: MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area
Other Name: Metrogel 1%
Active Comparator: 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: Doxycycline
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 During phase 1 (baseline - week 12) and 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® 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
Results First Received: December 17, 2013
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Doxycycline
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014