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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01426269
Recruitment Status : Completed
First Posted : August 31, 2011
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Tracking Information
First Submitted Date  ICMJE August 26, 2011
First Posted Date  ICMJE August 31, 2011
Results First Submitted Date  ICMJE December 17, 2013
Results First Posted Date  ICMJE August 4, 2014
Last Update Posted Date August 4, 2014
Study Start Date  ICMJE September 2011
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2011)
Percentage of subjects who relapse during phase 2 of the study [ Time Frame: Phase 2 (week 12 - week 52) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
  • 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).
  • 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.
  • Period 2: Inflammatory Lesion Count [ Time Frame: Period 2 (40 Weeks) ]
    The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2011)
  • Change from baseline in inflammatory lesion counts [ Time Frame: Baseline - week 52 ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Baseline - week 52 ]
    Number of participants with adverse events in each treatment arm.
Current Other Pre-specified Outcome Measures
 (submitted: July 8, 2014)
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
Official Title  ICMJE 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
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%.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rosacea
Intervention  ICMJE
  • 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%
  • Drug: Placebo
    During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Subjects will receive placebo during phase 2 (week 12 - week 52)
    Intervention: Drug: 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)
    Interventions:
    • Drug: Doxycycline
    • Drug: Metronidazole
  • 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)
    Intervention: Drug: Doxycycline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2014)
235
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2011)
200
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01426269
Other Study ID Numbers  ICMJE US10183
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma Laboratories, L.P.
Study Sponsor  ICMJE Galderma Laboratories, L.P.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
PRS Account Galderma Laboratories, L.P.
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP