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See Detailed Description
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group A | Experimental |
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| Treatment Group B | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin microspheres | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, Week 8 EOT |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Germona Del Friuli | Udine | 33013 | Italy | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Azithromycin | 2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension) |
| FG001 | Minocycline | 100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| minocycline-placebo capsules | Drug | minocycline-placebo capsules daily for 8 weeks plus minocycline placebo |
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| Azithromycin microspheres-placebo | Drug | Minocycline capsules, PO, 100 mg daily for 8 weeks and Azithromycin microspheres-placebo once a week for 8 weeks plus azithromycin placebo. |
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| Minocycline capsules, | Drug | Capsules, PO, 100 mg daily for 8 weeks. |
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| 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 %. | 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. | Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT |
| Bologna |
| 40121 |
| Italy |
| Pfizer Investigational Site | Catania | 95124 | Italy |
| Pfizer Investigational Site | Catanzaro | 88100 | Italy |
| Pfizer Investigational Site | Ferrara | 44100 | Italy |
| Pfizer Investigational Site | Genova | 16132 | Italy |
| Pfizer Investigational Site | Lucca | 55100 | Italy |
| Pfizer Investigational Site | Messina | 98100 | Italy |
| Pfizer Investigational Site | Milan | 20100 | Italy |
| Pfizer Investigational Site | Naples | 80131 | Italy |
| Pfizer Investigational Site | Pisa | 56126 | Italy |
| Pfizer Investigational Site | Pordenone | 33170 | Italy |
| Pfizer Investigational Site | Roma | 00161 | Italy |
| Pfizer Investigational Site | Roma | 00167 | Italy |
| Pfizer Investigational Site | Siena | 53100 | Italy |
| Pfizer Investigational Site | Terni | 05100 | Italy |
| Pfizer Investigational Site | Trieste | 34100 | Italy |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Azithromycin | 2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension) |
| BG001 | Minocycline | 100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set, Last Observation Carried Forward (LOCF) | Posted | Least Squares Mean | 95% Confidence Interval | score on scale | Baseline, Week 8 End of Treatment (EOT) |
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| Secondary | 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. | Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. Number of subjects with analyzable data: n=azithromycin, minocycline (respectively). | Posted | Mean | 95% Confidence Interval | score on scale | Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT |
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| Post-Hoc | Number of Subjects With Mild, Moderate, and Severe Acne | 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. | Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. | Posted | Number | participants | Baseline, Week 8 End of Treatment (EOT) |
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| Secondary | 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 %. | Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. | Posted | Number | participants | Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT |
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| Primary | 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. | Per Protocol population | Posted | Least Squares Mean | 95% Confidence Interval | score on scale | Baseline, Week 8 EOT |
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| Secondary | 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. | Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. Number of subjects with analyzable data: n=azithromycin, minocycline (respectively). | Posted | Mean | 95% Confidence Interval | score on scale | Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azithromycin | 2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension) | 0 | 58 | 29 | |||
| EG001 | Minocycline | 100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules) | 0 | 60 | 21 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelid edema | Eye disorders | MedDRA 11.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Abdominal pain, upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
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| Furnucle | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Localized infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Otitis media acute | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Migraine | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
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| Dysmenorrhea | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Title | Measurements |
|---|---|
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| Male |
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