Trial Outcomes & Findings for Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne (NCT NCT00392223)
NCT ID: NCT00392223
Last Updated: 2010-01-12
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
118 participants
Primary outcome timeframe
Baseline, Week 8 End of Treatment (EOT)
Results posted on
2010-01-12
Participant Flow
Participant milestones
| Measure |
Azithromycin
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
|
Minocycline
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
60
|
|
Overall Study
COMPLETED
|
49
|
47
|
|
Overall Study
NOT COMPLETED
|
9
|
13
|
Reasons for withdrawal
| Measure |
Azithromycin
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
|
Minocycline
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne
Baseline characteristics by cohort
| Measure |
Azithromycin
n=58 Participants
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
|
Minocycline
n=60 Participants
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years
|
10 participants
n=99 Participants
|
17 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Age, Customized
Between 18 and 44 years
|
48 participants
n=99 Participants
|
43 participants
n=107 Participants
|
91 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8 End of Treatment (EOT)Population: Full Analysis Set, Last Observation Carried Forward (LOCF)
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.
Outcome measures
| Measure |
Azithromycin
n=53 Participants
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
|
Minocycline
n=59 Participants
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
|
|---|---|---|
|
Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score
|
-8.69 score on scale
Interval -10.33 to -7.05
|
-9.16 score on scale
Interval -10.62 to -7.71
|
PRIMARY outcome
Timeframe: Baseline, Week 8 EOTPopulation: Per Protocol population
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.
Outcome measures
| Measure |
Azithromycin
n=48 Participants
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
|
Minocycline
n=48 Participants
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
|
|---|---|---|
|
Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population
|
-9.35 score on scale
Interval -10.75 to -7.94
|
-10.22 score on scale
Interval -11.54 to -8.9
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOTPopulation: Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. Number of subjects with analyzable data: n=azithromycin, minocycline (respectively).
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.
Outcome measures
| Measure |
Azithromycin
n=53 Participants
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
|
Minocycline
n=59 Participants
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
|
|---|---|---|
|
Change From Baseline in Global Acne Grading System (GAGS) Score
Week 4 (n=50,56)
|
-7.0 score on scale
95% Confidence Interval 7.05 • Interval -8.33 to -5.59
|
-6.5 score on scale
95% Confidence Interval 6.45 • Interval -7.77 to -5.16
|
|
Change From Baseline in Global Acne Grading System (GAGS) Score
Week 8 EOT (End of Treatment) (n=52,56)
|
-9.7 score on scale
Interval -11.66 to -7.77
|
-10.2 score on scale
Interval -11.86 to -8.57
|
|
Change From Baseline in Global Acne Grading System (GAGS) Score
Week 8 EOT (LOCF) (n=53,59)
|
-9.5 score on scale
Interval -11.47 to -7.59
|
-9.8 score on scale
Interval -11.48 to -8.12
|
|
Change From Baseline in Global Acne Grading System (GAGS) Score
8 weeks after EOT (n=49,49)
|
-11.1 score on scale
Interval -13.42 to -8.82
|
-12.9 score on scale
Interval -14.79 to -11.01
|
SECONDARY outcome
Timeframe: Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOTPopulation: Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used.
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 %.
Outcome measures
| Measure |
Azithromycin
n=53 Participants
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
|
Minocycline
n=59 Participants
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
|
|---|---|---|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 4 Best Improvement
|
1 participants
|
1 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 4 Good Improvement
|
4 participants
|
2 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 4 Moderate Improvement
|
19 participants
|
25 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 4 Light Improvement
|
23 participants
|
24 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 4 No Change
|
2 participants
|
2 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 4 Worsening
|
1 participants
|
2 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 4 Missing
|
3 participants
|
3 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 8 EOT Best Improvement
|
4 participants
|
3 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 8 EOT Good Improvement
|
11 participants
|
16 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 8 EOT Moderate Improvement
|
21 participants
|
20 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 8 EOT Light Improvement
|
11 participants
|
15 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 8 EOT No Change
|
2 participants
|
2 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 8 EOT Worsening
|
3 participants
|
0 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 8 EOT Missing
|
1 participants
|
3 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 8 EOT LOCF Best Improvement
|
4 participants
|
3 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 8 EOT LOCF Good Improvement
|
11 participants
|
16 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 8 EOT LOCF Moderate Improvement
|
21 participants
|
20 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 8 EOT LOCF Light Improvement
|
11 participants
|
17 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 8 EOT LOCF No Change
|
3 participants
|
2 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 8 EOT LOCF Worsening
|
3 participants
|
1 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
Week 8 EOT LOCF Missing
|
0 participants
|
0 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
8 weeks after EOT Best Improvement
|
7 participants
|
6 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
8 weeks after EOT Good Improvement
|
15 participants
|
17 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
8 weeks after EOT Moderate Improvement
|
13 participants
|
18 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
8 weeks after EOT Light Improvement
|
6 participants
|
8 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
8 weeks after EOT No Change
|
3 participants
|
0 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
8 weeks after EOT Worsening
|
5 participants
|
0 participants
|
|
Improvement of Global Acne Grading System (GAGS) Score
8 weeks after EOT Missing
|
4 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOTPopulation: Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. Number of subjects with analyzable data: n=azithromycin, minocycline (respectively).
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.
Outcome measures
| Measure |
Azithromycin
n=53 Participants
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
|
Minocycline
n=59 Participants
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
|
|---|---|---|
|
Change From Baseline in Acne Graded by Leeds Technique
Face Week 4 (n=50, 56)
|
-1.5 score on scale
Interval -1.82 to -1.14
|
-1.3 score on scale
Interval -1.6 to -1.05
|
|
Change From Baseline in Acne Graded by Leeds Technique
Face Week 8 EOT (n=52, 56)
|
-2.5 score on scale
Interval -3.06 to -2.01
|
-2.4 score on scale
Interval -2.84 to -2.02
|
|
Change From Baseline in Acne Graded by Leeds Technique
Face Week 8 EOT (LOCF) (n=53,59)
|
-2.5 score on scale
Interval -3.01 to -1.97
|
-2.3 score on scale
Interval -2.74 to -1.91
|
|
Change From Baseline in Acne Graded by Leeds Technique
Face 8 weeks after EOT (n=49,49)
|
-3.0 score on scale
Interval -3.65 to -2.35
|
-2.9 score on scale
Interval -3.44 to -2.39
|
|
Change From Baseline in Acne Graded by Leeds Technique
Back Week 4 (n=50,56)
|
-1.1 score on scale
Interval -1.58 to -0.7
|
-0.9 score on scale
Interval -1.21 to -0.61
|
|
Change From Baseline in Acne Graded by Leeds Technique
Back Week 8 EOT (n=52,56)
|
-1.5 score on scale
Interval -1.98 to -1.02
|
-1.4 score on scale
Interval -1.83 to -1.06
|
|
Change From Baseline in Acne Graded by Leeds Technique
Back Week 8 EOT (LOCF) (n=53,59)
|
-1.5 score on scale
Interval -1.96 to -1.02
|
-1.4 score on scale
Interval -1.76 to -0.99
|
|
Change From Baseline in Acne Graded by Leeds Technique
Back 8 weeks after EOT (n=49,49)
|
-1.5 score on scale
Interval -2.03 to -0.95
|
-2.0 score on scale
Interval -2.52 to -1.4
|
|
Change From Baseline in Acne Graded by Leeds Technique
Chest Week 4 (n=50,56)
|
-0.8 score on scale
Interval -1.12 to -0.48
|
-0.7 score on scale
Interval -0.99 to -0.4
|
|
Change From Baseline in Acne Graded by Leeds Technique
Chest Week 8 EOT (n=52,56)
|
-1.5 score on scale
Interval -2.04 to -0.92
|
-1.2 score on scale
Interval -1.57 to -0.75
|
|
Change From Baseline in Acne Graded by Leeds Technique
Chest Week 8 EOT (LOCF) (n=53,59)
|
-1.5 score on scale
Interval -2.0 to -0.9
|
-1.1 score on scale
Interval -1.51 to -0.73
|
|
Change From Baseline in Acne Graded by Leeds Technique
Chest 8 weeks after EOT (n=49,49)
|
-1.5 score on scale
Interval -2.1 to -0.92
|
-1.8 score on scale
Interval -2.32 to -1.23
|
POST_HOC outcome
Timeframe: Baseline, Week 8 End of Treatment (EOT)Population: Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used.
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.
Outcome measures
| Measure |
Azithromycin
n=53 Participants
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
|
Minocycline
n=59 Participants
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
|
|---|---|---|
|
Number of Subjects With Mild, Moderate, and Severe Acne
Baseline Mild acne
|
0 participants
|
1 participants
|
|
Number of Subjects With Mild, Moderate, and Severe Acne
Baseline Moderate acne
|
49 participants
|
52 participants
|
|
Number of Subjects With Mild, Moderate, and Severe Acne
Baseline Severe acne
|
3 participants
|
5 participants
|
|
Number of Subjects With Mild, Moderate, and Severe Acne
Baseline Very severe acne
|
1 participants
|
1 participants
|
|
Number of Subjects With Mild, Moderate, and Severe Acne
Baseline Missing
|
0 participants
|
0 participants
|
|
Number of Subjects With Mild, Moderate, and Severe Acne
Week 8 EOT (LOCF) Mild acne
|
31 participants
|
41 participants
|
|
Number of Subjects With Mild, Moderate, and Severe Acne
Week 8 EOT (LOCF) Moderate acne
|
19 participants
|
16 participants
|
|
Number of Subjects With Mild, Moderate, and Severe Acne
Week 8 EOT (LOCF) Severe acne
|
1 participants
|
0 participants
|
|
Number of Subjects With Mild, Moderate, and Severe Acne
Week 8 EOT (LOCF) Very severe acne
|
0 participants
|
1 participants
|
|
Number of Subjects With Mild, Moderate, and Severe Acne
Week 8 EOT (LOCF) Missing
|
2 participants
|
1 participants
|
Adverse Events
Azithromycin
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Minocycline
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Azithromycin
n=58 participants at risk
2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
|
Minocycline
n=60 participants at risk
100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
|
|---|---|---|
|
Eye disorders
Eyelid edema
|
0.00%
0/58
|
1.7%
1/60
|
|
Gastrointestinal disorders
Abdominal pain
|
12.1%
7/58
|
5.0%
3/60
|
|
Gastrointestinal disorders
Abdominal pain, upper
|
8.6%
5/58
|
3.3%
2/60
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/58
|
0.00%
0/60
|
|
Gastrointestinal disorders
Diarrhea
|
17.2%
10/58
|
3.3%
2/60
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
2/58
|
1.7%
1/60
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.7%
1/58
|
0.00%
0/60
|
|
Gastrointestinal disorders
Nausea
|
8.6%
5/58
|
1.7%
1/60
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
5/58
|
3.3%
2/60
|
|
General disorders
Fatigue
|
1.7%
1/58
|
0.00%
0/60
|
|
General disorders
Malaise
|
3.4%
2/58
|
0.00%
0/60
|
|
General disorders
Pyrexia
|
3.4%
2/58
|
6.7%
4/60
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/58
|
3.3%
2/60
|
|
Infections and infestations
Furnucle
|
1.7%
1/58
|
0.00%
0/60
|
|
Infections and infestations
Influenza
|
1.7%
1/58
|
1.7%
1/60
|
|
Infections and infestations
Localized infection
|
0.00%
0/58
|
1.7%
1/60
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
2/58
|
3.3%
2/60
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/58
|
1.7%
1/60
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/58
|
3.3%
2/60
|
|
Infections and infestations
Tonsillitis
|
1.7%
1/58
|
1.7%
1/60
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/58
|
1.7%
1/60
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/58
|
3.3%
2/60
|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
1/58
|
0.00%
0/60
|
|
Nervous system disorders
Disturbance in attention
|
1.7%
1/58
|
0.00%
0/60
|
|
Nervous system disorders
Headache
|
1.7%
1/58
|
5.0%
3/60
|
|
Reproductive system and breast disorders
Migraine
|
0.00%
0/58
|
1.7%
1/60
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/58
|
1.7%
1/60
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/58
|
1.7%
1/60
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER