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

Galderma

Status and phase: Completed; Phase 4

Conditions: Rosacea

Treatments: Drug: Doxycycline; Drug: Placebo; Drug: Metronidazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01426269

US10183

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 235 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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235 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Doxycycline and Metronidazole

Other group

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)

Treatment:

Drug: Metronidazole

Drug: Doxycycline

Doxycycline

Active Comparator group

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)

Treatment:

Drug: Doxycycline