Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Azithromycin microspheres

minocycline-placebo capsules

Azithromycin microspheres-placebo

Minocycline capsules,

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

male and female, > 16 years of age, with diagnosis of acne papulo-pustular, moderate (19-30 GAGS score) to severe (31-33 GAGS score)

Exclusion Criteria:

pregnancy, gastrointestinal and endocrinological disease, specific systemic disease, hormonal contraceptives, isotretinoin, topic drugs for acne (except detergent allowed)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Treatment Group A

Treatment Group B

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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 %.

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 Information

NCT ID

NCT00392223

First Posted

October 23, 2006

Last Updated

January 5, 2010

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00392223

Brief Title

Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

Official Title

A Phase III, Multicenter, Randomized, Double Blind-Double Dummy Study, To Evaluate Efficacy And Safety Of Treatment With Azithromycin, Microspheres, Oral Powder For Suspension, 2 G, In One Administration A Week, For 8 Weeks, Compared With Treatment With Minocycline Capsules, 100 Mg Die For 8 Weeks, In Outpatients With Moderate To Severe Inflammatory Acne.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Terminated

Why Stopped

See Detailed Description

Study Start Date

October 2007 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

118 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group A

Arm Type

Experimental

Arm Title

Treatment Group B

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Azithromycin microspheres

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

minocycline-placebo capsules

Intervention Description

minocycline-placebo capsules daily for 8 weeks plus minocycline placebo

Intervention Type

Drug

Intervention Name(s)

Azithromycin microspheres-placebo

Intervention Description

Minocycline capsules, PO, 100 mg daily for 8 weeks and Azithromycin microspheres-placebo once a week for 8 weeks plus azithromycin placebo.

Intervention Type

Drug

Intervention Name(s)

Minocycline capsules,

Intervention Description

Capsules, PO, 100 mg daily for 8 weeks.

Primary Outcome Measure Information:

Title

Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score

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)

Title

Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population

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

Secondary Outcome Measure Information:

Title

Change From Baseline in Global Acne Grading System (GAGS) Score

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

Title

Improvement of Global Acne Grading System (GAGS) Score

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

Title

Change From Baseline in Acne Graded by Leeds Technique

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: male and female, > 16 years of age, with diagnosis of acne papulo-pustular, moderate (19-30 GAGS score) to severe (31-33 GAGS score) Exclusion Criteria: pregnancy, gastrointestinal and endocrinological disease, specific systemic disease, hormonal contraceptives, isotretinoin, topic drugs for acne (except detergent allowed)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Germona Del Friuli

State/Province

Udine

ZIP/Postal Code

33013

Country

Italy

Facility Name

Pfizer Investigational Site

City

Bologna

ZIP/Postal Code

40121

Country

Italy

Facility Name

Pfizer Investigational Site

City

Catania

ZIP/Postal Code

95124

Country

Italy

Facility Name

Pfizer Investigational Site

City

Catanzaro

ZIP/Postal Code

88100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Ferrara

ZIP/Postal Code

44100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Pfizer Investigational Site

City

Lucca

ZIP/Postal Code

55100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Messina

ZIP/Postal Code

98100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Milano

ZIP/Postal Code

20100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Pfizer Investigational Site

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Pfizer Investigational Site

City

Pordenone

ZIP/Postal Code

33170

Country

Italy

Facility Name

Pfizer Investigational Site

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

Pfizer Investigational Site

City

Roma

ZIP/Postal Code

00167

Country

Italy

Facility Name

Pfizer Investigational Site

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Terni

ZIP/Postal Code

05100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Trieste

ZIP/Postal Code

34100

Country

Italy

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661150&StudyName=Efficacy%20And%20Safety%20Of%20Azithromycin%20SR%20Compared%20With%20Minocycline%20In%20Acne%20%20

Description

To obtain contact information for a study center near you, click here.

Acne Vulgaris

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial