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Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00392223
Recruitment Status : Terminated (See Detailed Description)
First Posted : October 25, 2006
Results First Posted : August 3, 2009
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Azithromycin microspheres
Drug: minocycline-placebo capsules
Drug: Azithromycin microspheres-placebo
Drug: Minocycline capsules,
Enrollment 118
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azithromycin Minocycline
Hide Arm/Group Description 2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension) 100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
Period Title: Overall Study
Started 58 60
Completed 49 47
Not Completed 9 13
Reason Not Completed
Adverse Event             5             4
Lost to Follow-up             1             4
Protocol Violation             0             3
Withdrawal by Subject             3             2
Arm/Group Title Azithromycin Minocycline Total
Hide Arm/Group Description 2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension) 100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules) Total of all reporting groups
Overall Number of Baseline Participants 58 60 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 60 participants 118 participants
<18 years 10 17 27
Between 18 and 44 years 48 43 91
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 60 participants 118 participants
Female
35
  60.3%
36
  60.0%
71
  60.2%
Male
23
  39.7%
24
  40.0%
47
  39.8%
1.Primary Outcome
Title Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score
Hide Description GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.
Time Frame Baseline, Week 8 End of Treatment (EOT)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, Last Observation Carried Forward (LOCF)
Arm/Group Title Azithromycin Minocycline
Hide Arm/Group Description:
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
Overall Number of Participants Analyzed 53 59
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on scale
-8.69
(-10.33 to -7.05)
-9.16
(-10.62 to -7.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin, Minocycline
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis performed to assess non-inferiority by calculation & examination of 95% CI. Analysis conducted via analysis of covariance (ANCOVA) including corresponding baseline value and centre as covariates. Non-inferiority margin was chosen as largest clinically acceptable difference. This was set as difference of 3 in GAGS global score. Azithromycin declared non-inferior to minocycline when two-sided 95% confidence interval for difference lied entirely to right of non-inferiority margin.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.47
Confidence Interval 95%
-2.48 to 1.54
Estimation Comments Comparison between treatment groups was performed using an analysis of covariance (ANCOVA) method, with treatment, center, and baseline value GAGS global score included as covariates.
2.Primary Outcome
Title Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population
Hide Description GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.
Time Frame Baseline, Week 8 EOT
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population
Arm/Group Title Azithromycin Minocycline
Hide Arm/Group Description:
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
Overall Number of Participants Analyzed 48 48
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on scale
-9.35
(-10.75 to -7.94)
-10.22
(-11.54 to -8.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin, Minocycline
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis performed to assess non-inferiority by calculation & examination of 95% CI. Analysis conducted via analysis of covariance (ANCOVA) including corresponding baseline value and centre as covariates. Non-inferiority margin was chosen as largest clinically acceptable difference. This was set as difference of 3 in GAGS global score. Azithromycin declared non-inferior to minocycline when two-sided 95% confidence interval for difference lied entirely to right of non-inferiority margin.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.87
Confidence Interval 95%
-2.58 to 0.84
Estimation Comments ANCOVA adjusted for baseline, center and treatment.
3.Secondary Outcome
Title Change From Baseline in Global Acne Grading System (GAGS) Score
Hide Description GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi. Global score factored based on summing of local scores. Change: mean at observation minus baseline.
Time Frame Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. Number of subjects with analyzable data: n=azithromycin, minocycline (respectively).
Arm/Group Title Azithromycin Minocycline
Hide Arm/Group Description:
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
Overall Number of Participants Analyzed 53 59
Mean (95% Confidence Interval)
Unit of Measure: score on scale
Week 4 (n=50,56)
-7.0
(-8.33 to -5.59)
-6.5
(-7.77 to -5.16)
Week 8 EOT (End of Treatment) (n=52,56)
-9.7
(-11.66 to -7.77)
-10.2
(-11.86 to -8.57)
Week 8 EOT (LOCF) (n=53,59)
-9.5
(-11.47 to -7.59)
-9.8
(-11.48 to -8.12)
8 weeks after EOT (n=49,49)
-11.1
(-13.42 to -8.82)
-12.9
(-14.79 to -11.01)
4.Secondary Outcome
Title Improvement of Global Acne Grading System (GAGS) Score
Hide Description Number of subjects by improvement category of GAGS score: Best improvement = reduction of GAGS score >75% (pre-post evaluation); Good improvement = reduction score > 50 - 75%; Moderate improvement : reduction score > 25 - 50%; Light improvement : reduction score > 0 - 25%; No change = reduction score = 0%; Worsening = increase score > 0 %.
Time Frame Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used.
Arm/Group Title Azithromycin Minocycline
Hide Arm/Group Description:
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
Overall Number of Participants Analyzed 53 59
Measure Type: Number
Unit of Measure: participants
Week 4 Best Improvement 1 1
Week 4 Good Improvement 4 2
Week 4 Moderate Improvement 19 25
Week 4 Light Improvement 23 24
Week 4 No Change 2 2
Week 4 Worsening 1 2
Week 4 Missing 3 3
Week 8 EOT Best Improvement 4 3
Week 8 EOT Good Improvement 11 16
Week 8 EOT Moderate Improvement 21 20
Week 8 EOT Light Improvement 11 15
Week 8 EOT No Change 2 2
Week 8 EOT Worsening 3 0
Week 8 EOT Missing 1 3
Week 8 EOT LOCF Best Improvement 4 3
Week 8 EOT LOCF Good Improvement 11 16
Week 8 EOT LOCF Moderate Improvement 21 20
Week 8 EOT LOCF Light Improvement 11 17
Week 8 EOT LOCF No Change 3 2
Week 8 EOT LOCF Worsening 3 1
Week 8 EOT LOCF Missing 0 0
8 weeks after EOT Best Improvement 7 6
8 weeks after EOT Good Improvement 15 17
8 weeks after EOT Moderate Improvement 13 18
8 weeks after EOT Light Improvement 6 8
8 weeks after EOT No Change 3 0
8 weeks after EOT Worsening 5 0
8 weeks after EOT Missing 4 10
5.Secondary Outcome
Title Change From Baseline in Acne Graded by Leeds Technique
Hide Description Leeds Grading technique: evaluates three sites (face, back, chest) on a 0 to 10 grading scale where 0 equals to no acne and 10 equals to most severe acne.
Time Frame Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. Number of subjects with analyzable data: n=azithromycin, minocycline (respectively).
Arm/Group Title Azithromycin Minocycline
Hide Arm/Group Description:
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
Overall Number of Participants Analyzed 53 59
Mean (95% Confidence Interval)
Unit of Measure: score on scale
Face Week 4 (n=50, 56)
-1.5
(-1.82 to -1.14)
-1.3
(-1.60 to -1.05)
Face Week 8 EOT (n=52, 56)
-2.5
(-3.06 to -2.01)
-2.4
(-2.84 to -2.02)
Face Week 8 EOT (LOCF) (n=53,59)
-2.5
(-3.01 to -1.97)
-2.3
(-2.74 to -1.91)
Face 8 weeks after EOT (n=49,49)
-3.0
(-3.65 to -2.35)
-2.9
(-3.44 to -2.39)
Back Week 4 (n=50,56)
-1.1
(-1.58 to -0.70)
-0.9
(-1.21 to -0.61)
Back Week 8 EOT (n=52,56)
-1.5
(-1.98 to -1.02)
-1.4
(-1.83 to -1.06)
Back Week 8 EOT (LOCF) (n=53,59)
-1.5
(-1.96 to -1.02)
-1.4
(-1.76 to -0.99)
Back 8 weeks after EOT (n=49,49)
-1.5
(-2.03 to -0.95)
-2.0
(-2.52 to -1.40)
Chest Week 4 (n=50,56)
-0.8
(-1.12 to -0.48)
-0.7
(-0.99 to -0.40)
Chest Week 8 EOT (n=52,56)
-1.5
(-2.04 to -0.92)
-1.2
(-1.57 to -0.75)
Chest Week 8 EOT (LOCF) (n=53,59)
-1.5
(-2.00 to -0.90)
-1.1
(-1.51 to -0.73)
Chest 8 weeks after EOT (n=49,49)
-1.5
(-2.10 to -0.92)
-1.8
(-2.32 to -1.23)
6.Post-Hoc Outcome
Title Number of Subjects With Mild, Moderate, and Severe Acne
Hide Description Global Acne Grading System score used to assess 6 locations on face/chest/upper back; factor for each based on area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on sum of local scores and se verity: 0=no acne, 1-18=mild, 19-30=moderate, 31-38=severe, >39=very severe.
Time Frame Baseline, Week 8 End of Treatment (EOT)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used.
Arm/Group Title Azithromycin Minocycline
Hide Arm/Group Description:
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
Overall Number of Participants Analyzed 53 59
Measure Type: Number
Unit of Measure: participants
Baseline Mild acne 0 1
Baseline Moderate acne 49 52
Baseline Severe acne 3 5
Baseline Very severe acne 1 1
Baseline Missing 0 0
Week 8 EOT (LOCF) Mild acne 31 41
Week 8 EOT (LOCF) Moderate acne 19 16
Week 8 EOT (LOCF) Severe acne 1 0
Week 8 EOT (LOCF) Very severe acne 0 1
Week 8 EOT (LOCF) Missing 2 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Azithromycin Minocycline
Hide Arm/Group Description 2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension) 100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
All-Cause Mortality
Azithromycin Minocycline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Azithromycin Minocycline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/60 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Azithromycin Minocycline
Affected / at Risk (%) Affected / at Risk (%)
Total   29   21 
Eye disorders     
Eyelid edema  1  0/58 (0.00%)  1/60 (1.67%) 
Gastrointestinal disorders     
Abdominal pain * 1  7/58 (12.07%)  3/60 (5.00%) 
Abdominal pain, upper  1  5/58 (8.62%)  2/60 (3.33%) 
Constipation  1  1/58 (1.72%)  0/60 (0.00%) 
Diarrhea  1  10/58 (17.24%)  2/60 (3.33%) 
Gastritis  1  2/58 (3.45%)  1/60 (1.67%) 
Gastrointestinal disorder  1  1/58 (1.72%)  0/60 (0.00%) 
Nausea  1  5/58 (8.62%)  1/60 (1.67%) 
Vomiting  1  5/58 (8.62%)  2/60 (3.33%) 
General disorders     
Fatigue  1  1/58 (1.72%)  0/60 (0.00%) 
Malaise  1  2/58 (3.45%)  0/60 (0.00%) 
Pyrexia  1  2/58 (3.45%)  4/60 (6.67%) 
Immune system disorders     
Hypersensitivity  1  0/58 (0.00%)  2/60 (3.33%) 
Infections and infestations     
Furnucle  1  1/58 (1.72%)  0/60 (0.00%) 
Influenza  1  1/58 (1.72%)  1/60 (1.67%) 
Localized infection  1  0/58 (0.00%)  1/60 (1.67%) 
Nasopharyngitis  1  2/58 (3.45%)  2/60 (3.33%) 
Otitis media acute  1  0/58 (0.00%)  1/60 (1.67%) 
Pharyngitis  1  0/58 (0.00%)  2/60 (3.33%) 
Tonsillitis  1  1/58 (1.72%)  1/60 (1.67%) 
Injury, poisoning and procedural complications     
Joint dislocation  1  0/58 (0.00%)  1/60 (1.67%) 
Investigations     
Alanine aminotransferase increased  1  0/58 (0.00%)  2/60 (3.33%) 
Metabolism and nutrition disorders     
Anorexia * 1  1/58 (1.72%)  0/60 (0.00%) 
Nervous system disorders     
Disturbance in attention  1  1/58 (1.72%)  0/60 (0.00%) 
Headache  1  1/58 (1.72%)  3/60 (5.00%) 
Reproductive system and breast disorders     
Migraine  1  0/58 (0.00%)  1/60 (1.67%) 
Dysmenorrhea  1  0/58 (0.00%)  1/60 (1.67%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/58 (0.00%)  1/60 (1.67%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
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.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00392223    
Other Study ID Numbers: A0661150
First Submitted: October 23, 2006
First Posted: October 25, 2006
Results First Submitted: June 11, 2009
Results First Posted: August 3, 2009
Last Update Posted: January 12, 2010