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Completed

NCT Number: NCT00612573

Treatment of Moderate to Severe Facial Acne Vulgaris

Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Warner Chilcott Investigational Site, Encino, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must be between 12 and 45 years of age.
  • Has a diagnosis of moderate to severe facial acne vulgaris with no more than two nodules on the face

Exclusion criteria

  • Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication.
  • Has a history of pseudomembranous colitis or antibiotic-associated colitis.
  • Has a history of hepatitis or liver damage or renal impairment.

Treatment and study plan

Doxycycline 0.6 mg/kg/day

Drug

doxycycline 40 mg/day, oral, 12 weeks

Doxycycline 1.2 mg/kg/day

Drug

doxycycline 80 mg/day, 12 weeks

Doxycycline 2.4 mg/kg/day

Drug

doxycycline 160 mg/day, 12 weeks

Placebo

Drug

Placebo, 12 weeks

Primary outcomes

  1. Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population

    Time frame: Week 12

    IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory & inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score.

  2. Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population

    Time frame: Baseline to Week 12

    Change derived as Baseline evaluation minus the Week 12 evaluation. Thus a positive change reflects a reduction in lesion count. Inflammatory Lesion Count includes nodules, papules and pustules.

Secondary outcomes

  1. Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population

    Time frame: Baseline to Week 12

    Noninflammatory Lesion Count includes open and closed comedones.

  2. Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population

    Time frame: Baseline to Week 12

    Total Lesion Count is the sum of inflammatory and noninflammatory lesions.

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study title

Phase 2 Study Randomized, Double-blind Study to Evaluate the Safety and Efficacy of 3 Doses of Doxycycline as Compared to Placebo in the Treatment of Moderate to Severe Facial Acne Vulgaris

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 11, 2008
Registry last updated
Apr 22, 2013

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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