Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea
This study is currently recruiting participants.
Verified October 2012 by Intendis GmbH
Sponsor:
Intendis GmbH
Information provided by (Responsible Party):
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT01555463
First received: March 13, 2012
Last updated: October 17, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Papulopustular Rosacea |
Drug: Azelaic Acid Drug: Vehicle Foam |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Intendis GmbH:
Primary Outcome Measures:
- Efficacy of Azelaic Acid Foam 15% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Evaluation by therapeutic success rate according to Investigators Global Assessment
- Efficacy of Azelaic Acid Foam 15% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Evaluation by change in inflammatory lesion count
Secondary Outcome Measures:
- Safety and tolerability of topical Azelaic Acid Foam 15% [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Evaluation of all Adverse Events
- Assess self-reported outcome parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Collection of subject's global assessments on treatment response and tolerability as well as subject's opinion on cosmetic parameters
- Assessment of effect of Azelaic Acid Foam (15%) and vehicle on parameters of quality of life in papulopustular rosacea [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Evaluation by using different Quality of Life questionnaires
| Estimated Enrollment: | 960 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Azelaic Acid Foam 15% |
Drug: Azelaic Acid
twice daily topical application
|
| Placebo Comparator: Vehicle Foam |
Drug: Vehicle Foam
twice daily topical application
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555463
Contacts
| Contact: Frank Czekalla, MD | +49.30.520075 ext 831 | frank.czekalla@bayer.com |
Locations
| United States, North Carolina | |
| Zoe Draelos, MD Principal Investigator | Recruiting |
| High Point, North Carolina, United States, 27262 | |
Sponsors and Collaborators
Intendis GmbH
More Information
No publications provided
| Responsible Party: | Intendis GmbH |
| ClinicalTrials.gov Identifier: | NCT01555463 History of Changes |
| Other Study ID Numbers: | 1401846, 16080 |
| Study First Received: | March 13, 2012 |
| Last Updated: | October 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Intendis GmbH:
|
Rosacea |
Additional relevant MeSH terms:
|
Rosacea Skin Diseases Azelaic acid Dermatologic Agents |
Therapeutic Uses Pharmacologic Actions Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013