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Completed

NCT Number: NCT01426269

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

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%.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ATS Clinical Research, Santa Monica, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doxycycline

Drug

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 names: Oracea® Capsules 40 mg

Metronidazole

Drug

During Phase 1: MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area

Other names: Metrogel 1%

Placebo

Drug

During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. Period 2: Inflammatory Lesion Count

    Time frame: Period 2 (40 Weeks)

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

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 31, 2011
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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