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Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

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ClinicalTrials.gov Identifier: NCT00635609
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : December 30, 2009
Last Update Posted : April 20, 2012
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Doxycycline hyclate (Doryx)
Drug: Doxycycline hyclate
Enrollment 93
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Doxycycline Hyclate (Doryx) Delayed-release Tablets Doxycycline Hyclate Immediate-release Tablets
Hide Arm/Group Description Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily Doxycycline hyclate immediate-release tablets, 100 mg once daily
Period Title: Overall Study
Started 48 45
Completed 41 42
Not Completed 7 3
Arm/Group Title Doxycycline Hyclate (Doryx) Delayed-release Tablets Doxycycline Hyclate Immediate-release Tablets Total
Hide Arm/Group Description Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily Doxycycline hyclate immediate-release tablets, 100 mg once daily Total of all reporting groups
Overall Number of Baseline Participants 48 45 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 45 participants 93 participants
<=18 years
28
  58.3%
21
  46.7%
49
  52.7%
Between 18 and 65 years
20
  41.7%
24
  53.3%
44
  47.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 45 participants 93 participants
19.3  (5.8) 20.9  (7.9) 20.1  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 45 participants 93 participants
Female
17
  35.4%
16
  35.6%
33
  35.5%
Male
31
  64.6%
29
  64.4%
60
  64.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 48 participants 45 participants 93 participants
48 45 93
Ethnic Origin  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 48 participants 45 participants 93 participants
Hispanic 27 26 53
Not of Hispanic origin 21 19 40
Race  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 48 participants 45 participants 93 participants
Asian or Pacific Islander 0 1 1
Black 3 5 8
Caucasian 22 18 40
Other 23 21 44
1.Primary Outcome
Title Successful Outcome According to Investigator's Global Assessment (IGA)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Hyclate (Doryx) Delayed-release Tablets Doxycycline Hyclate Immediate-release Tablets
Hide Arm/Group Description:
Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
Doxycycline hyclate immediate-release tablets, 100 mg once daily
Overall Number of Participants Analyzed 48 45
Measure Type: Number
Unit of Measure: participants
18 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline Hyclate (Doryx) Delayed-release Tablets, Doxycycline Hyclate Immediate-release Tablets
Comments Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.765
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified on investigational site.
2.Primary Outcome
Title Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT)
Arm/Group Title Doxycycline Hyclate (Doryx) Delayed-release Tablets Doxycycline Hyclate Immediate-release Tablets
Hide Arm/Group Description:
Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
Doxycycline hyclate immediate-release tablets, 100 mg once daily
Overall Number of Participants Analyzed 48 45
Mean (Standard Deviation)
Unit of Measure: acne lesion count
21.8  (13.8) 26.6  (12.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline Hyclate (Doryx) Delayed-release Tablets, Doxycycline Hyclate Immediate-release Tablets
Comments Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified on investigational site
3.Secondary Outcome
Title Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Hyclate (Doryx) Delayed-release Tablets Doxycycline Hyclate Immediate-release Tablets
Hide Arm/Group Description:
Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
Doxycycline hyclate immediate-release tablets, 100 mg once daily
Overall Number of Participants Analyzed 48 45
Mean (Standard Deviation)
Unit of Measure: Acne lesion count
23.2  (19.3) 27.6  (20.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline Hyclate (Doryx) Delayed-release Tablets, Doxycycline Hyclate Immediate-release Tablets
Comments Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.290
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified on investigational site.
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Doxycycline Hyclate (Doryx) Delayed-release Tablets Doxycycline Hyclate Immediate-release Tablets
Hide Arm/Group Description Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily Doxycycline hyclate immediate-release tablets, 100 mg once daily
All-Cause Mortality
Doxycycline Hyclate (Doryx) Delayed-release Tablets Doxycycline Hyclate Immediate-release Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Doxycycline Hyclate (Doryx) Delayed-release Tablets Doxycycline Hyclate Immediate-release Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/48 (2.08%)      1/45 (2.22%)    
Hepatobiliary disorders     
Acute cholecystitis * [1]  1/48 (2.08%)  1 0/45 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Ruptured ectopic pregnancy * [1]  0/48 (0.00%)  0 1/45 (2.22%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Intensity severe, unlikely related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Doxycycline Hyclate (Doryx) Delayed-release Tablets Doxycycline Hyclate Immediate-release Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/48 (20.83%)      11/45 (24.44%)    
Gastrointestinal disorders     
Nausea   0/48 (0.00%)  0 4/45 (8.89%)  4
Injury, poisoning and procedural complications     
Sunburn   3/48 (6.25%)  3 1/45 (2.22%)  1
Nervous system disorders     
Headache   7/48 (14.58%)  7 3/45 (6.67%)  3
Respiratory, thoracic and mediastinal disorders     
Nasopharyngitis   0/48 (0.00%)  0 3/45 (6.67%)  3
Indicates events were collected by systematic assessment
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
Name/Title: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
Phone: 973-442-3376
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00635609     History of Changes
Other Study ID Numbers: PR-08607
First Submitted: March 7, 2008
First Posted: March 14, 2008
Results First Submitted: September 23, 2009
Results First Posted: December 30, 2009
Last Update Posted: April 20, 2012