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 1, 2022
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rosacea | Drug: Doxycycline Drug: Metronidazole Drug: Placebo | Phase 4 |
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 |

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 |
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Study Director: | Ronald W Gottschalk, MD | Galderma R&D |
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 |
Rosacea Skin Diseases Metronidazole Doxycycline Anti-Infective Agents |
Anti-Bacterial Agents Antiprotozoal Agents Antiparasitic Agents Antimalarials |