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Treatment of Moderate to Severe Facial Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT00612573
Recruitment Status : Completed
First Posted : February 11, 2008
Results First Posted : April 19, 2011
Last Update Posted : April 22, 2013
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Doxycycline 0.6 mg/kg/day Drug: Doxycycline 1.2 mg/kg/day Drug: Doxycycline 2.4 mg/kg/day Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Doxycyline 0.6 mg/kg/day
Doxycycline dosed at 40 mg/day to subjects of appropriate weights
Drug: Doxycycline 0.6 mg/kg/day
doxycycline 40 mg/day, oral, 12 weeks
Experimental: Doxycycline 1.2 mg/kg/day
Doxycycline dosed at 80 mg/day to subjects of appropriate weights
Drug: Doxycycline 1.2 mg/kg/day
doxycycline 80 mg/day, 12 weeks
Experimental: Doxycycline 2.4 mg/kg/day
Doxycycline dosed at 160 mg/day to subjects of appropriate weights
Drug: Doxycycline 2.4 mg/kg/day
doxycycline 160 mg/day, 12 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo, 12 weeks



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612573


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Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Angelo Secci, MD Warner Chilcott

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00612573     History of Changes
Other Study ID Numbers: PR-07907
WC2055
First Posted: February 11, 2008    Key Record Dates
Results First Posted: April 19, 2011
Last Update Posted: April 22, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents