Back to resultsTreatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Doxycycline hyclate (Doryx)
Doxycycline hyclate
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Must be 12 years of age or older.
- Has a diagnosis of 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Doxycycline hyclate (Doryx)
Doxycycline hyclate
Arm Description
Outcomes
Primary Outcome Measures
Successful Outcome According to Investigator's Global Assessment (IGA)
The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.
Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks
Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.
Secondary Outcome Measures
Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks
Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00635609
Brief Title
Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate
Official Title
Randomized, Open-label Study to Evaluate the Efficacy and Safety of Doryx Tablets Compared to Doxycycline Hyclate in the Treatment of Acne Vulgaris.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 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, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.
Detailed Description
Efficacy of Doryx Delayed Release Tablets to doxycycline hyclate will be assessed using an Investigator's Global Assessment (IGA) score and the absolute change from baseline to 12 weeks in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline to 12 weeks in non-inflammatory lesions count of Doryx Delayed Release Tablets compared to doxycycline hyclate 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 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Doxycycline hyclate (Doryx)
Arm Type
Experimental
Arm Title
Doxycycline hyclate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Doxycycline hyclate (Doryx)
Other Intervention Name(s)
Doryx
Intervention Description
150mg/day, oral, delayed release tablets
Intervention Type
Drug
Intervention Name(s)
Doxycycline hyclate
Intervention Description
100 mg/day, oral, tablets, immediate release
Primary Outcome Measure Information:
Title
Successful Outcome According to Investigator's Global Assessment (IGA)
Description
The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.
Time Frame
baseline and 12 weeks
Title
Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks
Description
Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks
Description
Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.
Time Frame
baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be 12 years of age or older.
Has a diagnosis of 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
Vista
State/Province
California
ZIP/Postal Code
92083
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
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate
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