Overview

This trial is active, not recruiting.

Condition rosacea
Treatments oral doxycycline and topical metronidazole, oral doxycycline, placebo
Phase phase 4
Sponsor Galderma Laboratories, L.P.
Start date September 2011
End date June 2013
Trial size 200 participants
Trial identifier NCT01426269, US10183

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%.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Subjects will receive placebo during phase 2 (week 12 - week 52)
placebo Placebo
During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning
(Other)
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)
oral doxycycline and topical metronidazole Oracea® (doxycycline, USP) Capsules 40 mg and MetroGel® (metronidazole gel), 1%
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 and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area
(Active Comparator)
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)
oral doxycycline Oracea® (doxycycline, USP) Capsules 40 mg
During 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

Primary Outcomes

Measure
Percentage of subjects who relapse during phase 2 of the study
time frame: Phase 2 (week 12 - week 52)

Secondary Outcomes

Measure
Change from baseline in inflammatory lesion counts
time frame: Baseline - week 52
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: Baseline - week 52

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Galderma Laboratories, L.P..