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

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

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%.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: Placebo; Drug: Doxycycline; Drug: Metronidazole

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: Interventional
• Enrollment (Actual): 235
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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
Other: 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 Names: 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 Names: 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 Names: Oracea® Capsules 40 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Period 2: Investigator's Global Assessment Success	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 (40 weeks)
Period 2: Clinician's Erythema Assessment	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 (40 Weeks)
Period 2: Inflammatory Lesion Count	The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit.	Period 2 (40 Weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Period 1: Tolerability (Scaling)	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 (12 Weeks)
Period 1: Tolerability (Stinging/Burning)	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 (12 Weeks)
Period 1: Tolerability (Dryness)	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 (12 Weeks)

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: August 26, 2011
• First Submitted That Met QC Criteria: August 29, 2011
• First Posted (Estimate): August 31, 2011

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Metronidazole; Doxycycline
• Other Study ID Numbers: US10183