A Phase 3 interventional study of Azithromycin microspheres and minocycline-placebo capsules in Acne Vulgaris, sponsored by Pfizer. Terminated at 17 sites in Italy. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2010-01-12.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
The primary objective is to evaluate the clinical efficacy of azithromycin microspheres treatment in outpatients with moderate to severe inflammatory acne compared with first line treatment minocycline after 8 weeks of therapy
The study prematurely discontinued on the February 1, 2008 due to slow enrollment.It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 118 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Azithromycin microspheres · Drug: minocycline-placebo capsules
Drug: Azithromycin microspheres-placebo · Drug: Minocycline capsules,
Azithromycin microspheres, powder for oral suspension, 2 g a week, in unique administration PO, repeated weekly for 8 weeks and minocycline-placebo capsules daily for 8 weeks plus minocycline placebo
minocycline-placebo capsules daily for 8 weeks plus minocycline placebo
Minocycline capsules, PO, 100 mg daily for 8 weeks and Azithromycin microspheres-placebo once a week for 8 weeks plus azithromycin placebo.
Capsules, PO, 100 mg daily for 8 weeks.
Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score
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)
Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - 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.
Time frame: Baseline, Week 8 EOT
Change From Baseline in Global Acne Grading System (GAGS) Score
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
Improvement of Global Acne Grading System (GAGS) Score
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
Change From Baseline in Acne Graded by Leeds Technique
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
| Milestone | Azithromycin | Minocycline |
|---|---|---|
| Started | 58 | 60 |
| Completed | 49 | 47 |
| Not completed | 9 | 13 |
| Withdrew: Adverse event | 5 | 4 |
| Withdrew: Lost to follow-up | 1 | 4 |
| Withdrew: Protocol violation | 0 | 3 |
| Withdrew: Withdrawal by subject | 3 | 2 |
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.
| score on scale | Azithromycin | Minocycline |
|---|---|---|
| Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score | -8.69 (-10.33 to -7.05) | -9.16 (-10.62 to -7.71) |
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.
| score on scale | Azithromycin | Minocycline |
|---|---|---|
| Week 4 (n=50,56) | -7.0 ± 7.05 | -6.5 ± 6.45 |
| 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) |
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.
| participants | Azithromycin | Minocycline |
|---|---|---|
| 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 |
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 %.
| participants | Azithromycin | Minocycline |
|---|---|---|
| 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 |
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.
| score on scale | Azithromycin | Minocycline |
|---|---|---|
| Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population | -9.35 (-10.75 to -7.94) | -10.22 (-11.54 to -8.90) |
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.
| score on scale | Azithromycin | Minocycline |
|---|---|---|
| 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) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Azithromycin | — | 0/58 (0%) | — |
| Minocycline | — | 0/60 (0%) | — |
| Event | Azithromycin | Minocycline |
|---|---|---|
| DiarrheaGastrointestinal disorders | 10/58 | 2/60 |
| Abdominal painGastrointestinal disorders | 7/58 | 3/60 |
| Abdominal pain, upperGastrointestinal disorders | 5/58 | 2/60 |
| NauseaGastrointestinal disorders | 5/58 | 1/60 |
| VomitingGastrointestinal disorders | 5/58 | 2/60 |
| PyrexiaGeneral disorders | 2/58 | 4/60 |
| HeadacheNervous system disorders | 1/58 | 3/60 |
| GastritisGastrointestinal disorders | 2/58 | 1/60 |
| MalaiseGeneral disorders | 2/58 | 0/60 |
| NasopharyngitisInfections and infestations | 2/58 | 2/60 |
| Age, Customized(participants) | Azithromycin | Minocycline | Total |
|---|---|---|---|
| <18 years | 10 | 17 | 27 |
| Between 18 and 44 years | 48 | 43 | 91 |
| Sex: Female, Male(Participants) | Azithromycin | Minocycline | Total |
|---|---|---|---|
| Female | 35 | 36 | 71 |
| Male | 23 | 24 | 47 |
This study is terminated, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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