Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
1 other identifier
interventional
235
1 country
11
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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2011
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2011
CompletedFirst Posted
Study publicly available on registry
August 31, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
August 4, 2014
CompletedAugust 1, 2022
July 1, 2014
1.8 years
August 26, 2011
December 17, 2013
July 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Period 2: Number of Subjects Who Relapsed
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.
Period 2 (40 weeks)
Secondary Outcomes (3)
Period 2: Investigator's Global Assessment Success
Period 2 (40 weeks)
Period 2: Clinician's Erythema Assessment
Period 2 (40 Weeks)
Period 2: Inflammatory Lesion Count
Period 2 (40 Weeks)
Other Outcomes (3)
Period 1: Tolerability (Scaling)
Period 1 (12 Weeks)
Period 1: Tolerability (Stinging/Burning)
Period 1 (12 Weeks)
Period 1: Tolerability (Dryness)
Period 1 (12 Weeks)
Study Arms (3)
Placebo
PLACEBO COMPARATORSubjects will receive placebo during phase 2 (week 12 - week 52)
Doxycycline and Metronidazole
OTHERSubjects 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)
Doxycycline
ACTIVE COMPARATORSubjects 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)
Interventions
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
During Phase 1: MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area
During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (11)
ATS Clinical Research
Santa Monica, California, 90404, United States
Dadeland Dermatology
Coral Gables, Florida, 33134, United States
Melissa L. F. Knuckles M.D., P.S.C.
Corbin, Kentucky, 40701, United States
Dermatology Specialists Research
Louisville, Kentucky, 40202, United States
Melissa L. F. Knuckles M.D., P.S.C.
Richmond, Kentucky, 40475, United States
The Maryland Laser, Skin, and Vein Institute, LLC
Hunt Valley, Maryland, 21030, United States
Grekin Skin Institute
Warren, Michigan, 48088, United States
Hilary Baldwin
Brooklyn, New York, 11201, United States
The Center for Dermatology at Linden Oaks
Rochester, New York, 14625, United States
Brodell Medical, Inc.
Warren, Ohio, 44483, United States
Center for Dermatology and Laser Surgery
Portland, Oregon, 97225, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elizabeth M Nieman
- Organization
- Galderma Laboratories, L.P.
Study Officials
- STUDY DIRECTOR
Ronald W Gottschalk, MD
Galderma R&D
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2011
First Posted
August 31, 2011
Study Start
September 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
August 1, 2022
Results First Posted
August 4, 2014
Record last verified: 2014-07