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

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ClinicalTrials.gov Identifier: NCT01426269
Recruitment Status : Completed
First Posted : August 31, 2011
Results First Posted : August 4, 2014
Last Update Posted : August 1, 2022
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Rosacea Drug: Doxycycline Drug: Metronidazole Drug: Placebo Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Period 2: Number of Subjects Who Relapsed [ Time Frame: Period 2 (40 weeks) ]

    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 :
  1. Period 2: Investigator's Global Assessment Success [ Time Frame: Period 2 (40 weeks) ]
    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).

  2. Period 2: Clinician's Erythema Assessment [ Time Frame: Period 2 (40 Weeks) ]
    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.

  3. Period 2: Inflammatory Lesion Count [ Time Frame: Period 2 (40 Weeks) ]
    The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit.


Other Outcome Measures:
  1. Period 1: Tolerability (Scaling) [ Time Frame: Period 1 (12 Weeks) ]
    Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.

  2. Period 1: Tolerability (Stinging/Burning) [ Time Frame: Period 1 (12 Weeks) ]
    Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.

  3. Period 1: Tolerability (Dryness) [ Time Frame: Period 1 (12 Weeks) ]
    Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426269


Locations
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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 R&D
Investigators
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Study Director: Ronald W Gottschalk, MD Galderma R&D
More Information
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01426269    
Other Study ID Numbers: US10183
First Posted: August 31, 2011    Key Record Dates
Results First Posted: August 4, 2014
Last Update Posted: August 1, 2022
Last Verified: July 2014
Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Metronidazole
Doxycycline
Anti-Infective Agents
 Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Antimalarials