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

Primary Purpose

Rosacea

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Doxycycline
Metronidazole
Placebo
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ATS Clinical Research
  • Dadeland Dermatology
  • Melissa L. F. Knuckles M.D., P.S.C.
  • Dermatology Specialists Research
  • Melissa L. F. Knuckles M.D., P.S.C.
  • The Maryland Laser, Skin, and Vein Institute, LLC
  • Grekin Skin Institute
  • Hilary Baldwin
  • The Center for Dermatology at Linden Oaks
  • Brodell Medical, Inc.
  • Center for Dermatology and Laser Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Other

Active Comparator

Arm Label

Placebo

Doxycycline and Metronidazole

Doxycycline

Arm Description

Subjects will receive placebo during phase 2 (week 12 - week 52)

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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: 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: Inflammatory Lesion Count
The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit.

Full Information

First Posted
August 26, 2011
Last Updated
July 28, 2022
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01426269
Brief Title
Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo during phase 2 (week 12 - week 52)
Arm Title
Doxycycline and Metronidazole
Arm Type
Other
Arm Description
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)
Arm Title
Doxycycline
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Doxycycline
Other Intervention Name(s)
Oracea® Capsules 40 mg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Other Intervention Name(s)
Metrogel 1%
Intervention Description
During Phase 1: MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning
Primary Outcome Measure Information:
Title
Period 2: Number of Subjects Who Relapsed
Description
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.
Time Frame
Period 2 (40 weeks)
Secondary Outcome Measure Information:
Title
Period 2: Investigator's Global Assessment Success
Description
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).
Time Frame
Period 2 (40 weeks)
Title
Period 2: Clinician's Erythema Assessment
Description
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.
Time Frame
Period 2 (40 Weeks)
Title
Period 2: Inflammatory Lesion Count
Description
The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit.
Time Frame
Period 2 (40 Weeks)
Other Pre-specified Outcome Measures:
Title
Period 1: Tolerability (Scaling)
Description
Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.
Time Frame
Period 1 (12 Weeks)
Title
Period 1: Tolerability (Stinging/Burning)
Description
Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.
Time Frame
Period 1 (12 Weeks)
Title
Period 1: Tolerability (Dryness)
Description
Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.
Time Frame
Period 1 (12 Weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald W Gottschalk, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
ATS Clinical Research
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Dadeland Dermatology
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Melissa L. F. Knuckles M.D., P.S.C.
City
Corbin
State/Province
Kentucky
ZIP/Postal Code
40701
Country
United States
Facility Name
Dermatology Specialists Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Melissa L. F. Knuckles M.D., P.S.C.
City
Richmond
State/Province
Kentucky
ZIP/Postal Code
40475
Country
United States
Facility Name
The Maryland Laser, Skin, and Vein Institute, LLC
City
Hunt Valley
State/Province
Maryland
ZIP/Postal Code
21030
Country
United States
Facility Name
Grekin Skin Institute
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Hilary Baldwin
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
The Center for Dermatology at Linden Oaks
City
Rochester
State/Province
New York
ZIP/Postal Code
14625
Country
United States
Facility Name
Brodell Medical, Inc.
City
Warren
State/Province
Ohio
ZIP/Postal Code
44483
Country
United States
Facility Name
Center for Dermatology and Laser Surgery
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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