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

Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426269
• Other study ID #: US10183
• Status: Completed
• Phase: Phase 4
• Start date: September 2011
• Est. completion date: June 2013

Study information

• Verified date: July 2014
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rosacea

Intervention

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
• Metronidazole
During Phase 1: MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area
• Placebo
During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning

Locations

Country	Name	City	State
United States	Hilary Baldwin	Brooklyn	New York
United States	Dadeland Dermatology	Coral Gables	Florida
United States	Melissa L. F. Knuckles M.D., P.S.C.	Corbin	Kentucky
United States	The Maryland Laser, Skin, and Vein Institute, LLC	Hunt Valley	Maryland
United States	Dermatology Specialists Research	Louisville	Kentucky
United States	Center for Dermatology and Laser Surgery	Portland	Oregon
United States	Melissa L. F. Knuckles M.D., P.S.C.	Richmond	Kentucky
United States	The Center for Dermatology at Linden Oaks	Rochester	New York
United States	ATS Clinical Research	Santa Monica	California
United States	Brodell Medical, Inc.	Warren	Ohio
United States	Grekin Skin Institute	Warren	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Primary	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	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)
Secondary	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)
Secondary	Period 2: Inflammatory Lesion Count	The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit.	Period 2 (40 Weeks)