DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea

Information source: Intendis GmbH
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Papulopustular Rosacea

Intervention: Azelaic Acid (Drug); Vehicle Foam (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Intendis GmbH

Overall contact:
Frank Czekalla, MD, Phone: +49.30.520075, Ext: 831, Email: frank.czekalla@bayer.com

Summary

The purpose of this study is to assess the safety and efficacy of Azelaic Acid Foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.

Clinical Details

Official title: A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Clinical Trial to Assess the Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily for 12 Weeks in Subjects With Papulopustular Rosacea

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Efficacy of Azelaic Acid Foam 15%

Efficacy of Azelaic Acid Foam 15%

Secondary outcome:

Safety and tolerability of topical Azelaic Acid Foam 15%

Assess self-reported outcome parameters

Assessment of effect of Azelaic Acid Foam (15%) and vehicle on parameters of quality of life in papulopustular rosacea

Detailed description: To determine the efficacy of AzA Foam, 15% compared to vehicle topically applied twice daily in papulopustular rosacea evaluated by therapeutic success rate according to Investigators Global Assessment and change in inflammatory lesion count from baseline to end of treatment.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of papulopustular rosacea

- Free of any clinically significant disease, which could interfere with the study

- Male or female subject aged ≥ 18 years

- Willingness of subject to follow all study procedures

- Signed written informed consent before any study-related activities are carried out

Exclusion Criteria:

- Subjects who are known to be non-responders to azelaic acid

- Presence of dermatoses that might interfere with rosacea diagnosis

- Ocular rosacea; phymatous rosacea; subjects with plaque-type rosacea lesions,

papulopustular rosacea that requires systemic treatment

- Topical use of any prescription or non-prescription medication to treat rosacea

within 6 weeks prior to randomization and throughout the study

- Systemic use of any prescription or non-prescription medication to treat rosacea

(Retinoids within 6 months, Tetracycline within 2 months, Corticosteroids, erythromycin, azithromycine, and/or metronidazole within 4 weeks) prior to randomization and throughout the study

- Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to

randomization

- Known hypersensitivity to any ingredients of the investigational product formulation

- Participation in another clinical research in parallel or within the last 4 weeks

before randomization in this study

- Any condition or therapy that in the investigator's opinion may pose a risk to the

subject or that could interfere with any evaluation in the study

Locations and Contacts

Frank Czekalla, MD, Phone: +49.30.520075, Ext: 831, Email: frank.czekalla@bayer.com

Zoe Draelos, MD Principal Investigator, High Point, North Carolina 27262, United States; Recruiting
Additional Information

Starting date: September 2012
Last updated: October 17, 2012

Page last updated: February 07, 2013

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012