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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Doxycycline 0.6 mg/kg/day
Drug: Doxycycline 1.2 mg/kg/day
Drug: Doxycycline 2.4 mg/kg/day
Drug: Placebo
Enrollment 257
Recruitment Details Recruitment began 4 Mar '08
Pre-assignment Details  
Arm/Group Title Doxycycline 0.6 mg/kg/Day Doxycycline 1.2 mg/kg/Day Doxycycline 2.4 mg/kg/Day Placebo Comparator
Hide Arm/Group Description 40 mg doxycycline tablet plus 2 placebo tablets daily 80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily 160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily 3 placebo tablets daily matching active 40 & 80 mg tablets
Period Title: Overall Study
Started 64 65 61 67
Completed 52 51 52 54
Not Completed 12 14 9 13
Arm/Group Title Doxycycline 0.6 mg/kg/Day Doxycycline 1.2 mg/kg/Day Doxycycline 2.4 mg/kg/Day Placebo Comparator Total
Hide Arm/Group Description 40 mg doxycycline tablet plus 2 placebo tablets daily 80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily 160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily 3 placebo tablets daily matching active 40 & 80 mg tablets Total of all reporting groups
Overall Number of Baseline Participants 64 65 61 67 257
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 65 participants 61 participants 67 participants 257 participants
19.3  (5.2) 19.4  (6.6) 20.7  (7.4) 20.2  (7.5) 19.9  (6.7)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants 65 participants 61 participants 67 participants 257 participants
>= 18 years 32 39 27 35 133
< 18 years 32 26 34 32 124
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 65 participants 61 participants 67 participants 257 participants
Female
35
  54.7%
30
  46.2%
36
  59.0%
35
  52.2%
136
  52.9%
Male
29
  45.3%
35
  53.8%
25
  41.0%
32
  47.8%
121
  47.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 64 participants 65 participants 61 participants 67 participants 257 participants
64 65 61 67 257
1.Primary Outcome
Title Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Doxycycline 0.6 mg/kg/Day Doxycycline 1.2 mg/kg/Day Doxycycline 2.4 mg/kg/Day Placebo Comparator
Hide Arm/Group Description:
40 mg doxycycline tablet plus 2 placebo tablets daily
80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
3 placebo tablets daily matching active 40 & 80 mg tablets
Overall Number of Participants Analyzed 64 65 61 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
14.1
(6.6 to 25.0)
15.4
(7.6 to 26.5)
29.5
(18.5 to 42.6)
16.4
(8.5 to 27.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline 0.6 mg/kg/Day, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.779
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Investigational Site
Method of Estimation Estimation Parameter Mean Change from Baseline
Estimated Value -0.75
Confidence Interval (2-Sided) 95%
-14.8 to 10.3
Parameter Dispersion
Type: Standard Deviation
Value: 0.85
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Doxycycline 1.2 mg/kg/Day, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.983
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Investigational Site
Method of Estimation Estimation Parameter Mean Change from Baseline
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-13.7 to 11.7
Parameter Dispersion
Type: Standard Deviation
Value: 0.90
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Doxycycline 2.4 mg/kg/Day, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Investigational Site
Method of Estimation Estimation Parameter Mean Change from Baseline
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-1.5 to 27.3
Parameter Dispersion
Type: Standard Deviation
Value: 0.97
Estimation Comments [Not Specified]
2.Primary Outcome
Title Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Doxycycline 0.6 mg/kg/Day Doxycycline 1.2 mg/kg/Day Doxycycline 2.4 mg/kg/Day Placebo Comparator
Hide Arm/Group Description:
40 mg doxycycline tablet plus 2 placebo tablets daily
80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
3 placebo tablets daily matching active 40 & 80 mg tablets
Overall Number of Participants Analyzed 64 65 61 67
Mean (Standard Deviation)
Unit of Measure: Lesions
8.1  (13.2) 11.5  (12.1) 14.0  (19.7) 7.3  (13.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline 0.6 mg/kg/Day, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.807
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Investigational Site
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Doxycycline 1.2 mg/kg/Day, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Investigational Site
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Doxycycline 2.4 mg/kg/Day, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Investigational Site
3.Secondary Outcome
Title Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population
Hide Description Noninflammatory Lesion Count includes open and closed comedones.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Doxycycline 0.6 mg/kg/Day Doxycycline 1.2 mg/kg/Day Doxycycline 2.4 mg/kg/Day Placebo Comparator
Hide Arm/Group Description:
40 mg doxycycline tablet plus 2 placebo tablets daily
80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
3 placebo tablets daily matching active 40 & 80 mg tablets
Overall Number of Participants Analyzed 64 65 61 67
Mean (Standard Deviation)
Unit of Measure: Lesions
8.5  (19.1) 5.2  (28.1) 6.5  (16.2) 1.8  (31.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline 0.6 mg/kg/Day, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.212
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Investigational Site
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Doxycycline 1.2 mg/kg/Day, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.505
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Investigational Site
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Doxycycline 2.4 mg/kg/Day, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.399
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Investigational Site
4.Secondary Outcome
Title Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population
Hide Description Total Lesion Count is the sum of inflammatory and noninflammatory lesions.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Doxycycline 0.6 mg/kg/Day Doxycycline 1.2 mg/kg/Day Doxycycline 2.4 mg/kg/Day Placebo Comparator
Hide Arm/Group Description:
40 mg doxycycline tablet plus 2 placebo tablets daily
80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
3 placebo tablets daily matching active 40 & 80 mg tablets
Overall Number of Participants Analyzed 64 65 61 67
Mean (Standard Deviation)
Unit of Measure: Lesions
16.6  (25.6) 16.8  (32.7) 20.5  (25.0) 9.1  (38.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline 0.6 mg/kg/Day, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.276
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Investigational Site
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Doxycycline 1.2 mg/kg/Day, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.231
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Investigational Site
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Doxycycline 2.4 mg/kg/Day, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.081
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by Investigational Site
Time Frame 4 Mar 2008 thru 6 Nov 2008
Adverse Event Reporting Description 12 week treatment period for each participant
 
Arm/Group Title Doxycycline 0.6 mg/kg/Day Doxycycline 1.2 mg/kg/Day Doxycycline 2.4 mg/kg/Day Placebo Comparator
Hide Arm/Group Description 40 mg doxycycline tablet plus 2 placebo tablets daily 80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily 160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily 3 placebo tablets daily matching active 40 & 80 mg tablets
All-Cause Mortality
Doxycycline 0.6 mg/kg/Day Doxycycline 1.2 mg/kg/Day Doxycycline 2.4 mg/kg/Day Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Doxycycline 0.6 mg/kg/Day Doxycycline 1.2 mg/kg/Day Doxycycline 2.4 mg/kg/Day Placebo Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/64 (0.00%)      0/65 (0.00%)      0/61 (0.00%)      1/67 (1.49%)    
Injury, poisoning and procedural complications         
Fracture (Left Radius)  1  0/64 (0.00%)  0 0/65 (0.00%)  0 0/61 (0.00%)  0 1/67 (1.49%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Doxycycline 0.6 mg/kg/Day Doxycycline 1.2 mg/kg/Day Doxycycline 2.4 mg/kg/Day Placebo Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/64 (34.38%)      20/65 (30.77%)      29/61 (47.54%)      25/67 (37.31%)    
Gastrointestinal disorders         
Diarrhea  1  3/64 (4.69%)  2/65 (3.08%)  2/61 (3.28%)  0/67 (0.00%) 
Gastroenteritis  1  0/64 (0.00%)  0/65 (0.00%)  2/61 (3.28%)  0/67 (0.00%) 
Nausea  1  0/64 (0.00%)  1/65 (1.54%)  8/61 (13.11%)  2/67 (2.99%) 
Toothache  1  2/64 (3.13%)  2/65 (3.08%)  0/61 (0.00%)  1/67 (1.49%) 
Vomiting  1  1/64 (1.56%)  1/65 (1.54%)  4/61 (6.56%)  0/67 (0.00%) 
Immune system disorders         
Seasonal Allergy  1  1/64 (1.56%)  0/65 (0.00%)  0/61 (0.00%)  2/67 (2.99%) 
Injury, poisoning and procedural complications         
Sunburn  1  0/64 (0.00%)  4/65 (6.15%)  1/61 (1.64%)  1/67 (1.49%) 
Musculoskeletal and connective tissue disorders         
Back Pain  1  2/64 (3.13%)  0/65 (0.00%)  0/61 (0.00%)  0/67 (0.00%) 
Myalgia  1  0/64 (0.00%)  0/65 (0.00%)  2/61 (3.28%)  1/67 (1.49%) 
Nervous system disorders         
Headache  1  6/64 (9.38%)  4/65 (6.15%)  4/61 (6.56%)  5/67 (7.46%) 
Procedural Pain  1  2/64 (3.13%)  0/65 (0.00%)  1/61 (1.64%)  2/67 (2.99%) 
Reproductive system and breast disorders         
Dysmenorrhoea  1  1/64 (1.56%)  1/65 (1.54%)  1/61 (1.64%)  2/67 (2.99%) 
Respiratory, thoracic and mediastinal disorders         
Nasopharyngitis  1  1/64 (1.56%)  2/65 (3.08%)  2/61 (3.28%)  2/67 (2.99%) 
Pharyngolaryngeal Pain  1  1/64 (1.56%)  0/65 (0.00%)  1/61 (1.64%)  3/67 (4.48%) 
Upper Respiratory Tract Infection  1  2/64 (3.13%)  1/65 (1.54%)  0/61 (0.00%)  2/67 (2.99%) 
Skin and subcutaneous tissue disorders         
Dermatitis Contact  1  0/64 (0.00%)  0/65 (0.00%)  1/61 (1.64%)  2/67 (2.99%) 
Fungal Infection  1  0/64 (0.00%)  2/65 (3.08%)  0/61 (0.00%)  0/67 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
Phone: 973-442-3376
EMail: gwulff@wcrx.com
Layout table for additonal information
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00612573     History of Changes
Other Study ID Numbers: PR-07907
WC2055
First Submitted: January 25, 2008
First Posted: February 11, 2008
Results First Submitted: February 14, 2011
Results First Posted: April 19, 2011
Last Update Posted: April 22, 2013