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Treatment of Moderate to Severe Facial Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Doxycycline 0.6 mg/kg/day
Doxycycline 1.2 mg/kg/day
Doxycycline 2.4 mg/kg/day
Placebo
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Doxycyline 0.6 mg/kg/day

Doxycycline 1.2 mg/kg/day

Doxycycline 2.4 mg/kg/day

Placebo

Arm Description

Doxycycline dosed at 40 mg/day to subjects of appropriate weights

Doxycycline dosed at 80 mg/day to subjects of appropriate weights

Doxycycline dosed at 160 mg/day to subjects of appropriate weights

Outcomes

Primary Outcome Measures

Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population
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.
Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population
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

Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population
Noninflammatory Lesion Count includes open and closed comedones.
Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population
Total Lesion Count is the sum of inflammatory and noninflammatory lesions.

Full Information

First Posted
January 25, 2008
Last Updated
April 15, 2013
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT00612573
Brief Title
Treatment of Moderate to Severe Facial Acne Vulgaris
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 Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doxycyline 0.6 mg/kg/day
Arm Type
Experimental
Arm Description
Doxycycline dosed at 40 mg/day to subjects of appropriate weights
Arm Title
Doxycycline 1.2 mg/kg/day
Arm Type
Experimental
Arm Description
Doxycycline dosed at 80 mg/day to subjects of appropriate weights
Arm Title
Doxycycline 2.4 mg/kg/day
Arm Type
Experimental
Arm Description
Doxycycline dosed at 160 mg/day to subjects of appropriate weights
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Doxycycline 0.6 mg/kg/day
Intervention Description
doxycycline 40 mg/day, oral, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Doxycycline 1.2 mg/kg/day
Intervention Description
doxycycline 80 mg/day, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Doxycycline 2.4 mg/kg/day
Intervention Description
doxycycline 160 mg/day, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, 12 weeks
Primary Outcome Measure Information:
Title
Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population
Description
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.
Time Frame
Week 12
Title
Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population
Description
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.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population
Description
Noninflammatory Lesion Count includes open and closed comedones.
Time Frame
Baseline to Week 12
Title
Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population
Description
Total Lesion Count is the sum of inflammatory and noninflammatory lesions.
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo Secci, MD
Organizational Affiliation
Warner Chilcott
Official's Role
Study Director
Facility Information:
Facility Name
Warner Chilcott Investigational Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106-5239
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Fort Washington
State/Province
Pennsylvania
ZIP/Postal Code
19034
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Moderate to Severe Facial Acne Vulgaris

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