Exploratory Study of Azelaic Acid 15% Foam Compared to Vehicle in Patients With Papulopustular Rosacea - Full Text View

Sponsored by:	Intendis GmbH
Information provided by:	Intendis GmbH
ClinicalTrials.gov Identifier:	NCT00617903

Purpose

This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.

Condition	Intervention	Phase
Papulopustular Rosacea	Drug: Azelaic acid Drug: Vehicle	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-week Exploratory, Multicenter, Double-blind, Vehicle-controlled Study to Investigate the Efficacy and Safety of Topical Azelaic Acid 15% Foam Twice Daily in Patients With Papulopustular Rosacea

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Azelaic acid

U.S. FDA Resources

Further study details as provided by Intendis GmbH:

Primary Outcome Measures:

Nominal change in inflammatory lesion [ Time Frame: From baseline to the end of treatment ] [ Designated as safety issue: No ]
Investigator's Global Assessment dichotomized into success and failure [ Time Frame: At the end of treatment ] [ Designated as safety issue: No ]
Change in erythema rating on a four-point scale [ Time Frame: From baseline to the end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Absolute values and percentage change from baseline for the inflammatory lesion count [ Time Frame: From baseline to the end of treatment ] [ Designated as safety issue: No ]
Absolute values and nominal change from baseline for the IGA of rosacea [ Time Frame: From baseline to the end of treatment ] [ Designated as safety issue: No ]
Absolute values and rating changes of erythema and telangiectasia [ Time Frame: From baseline to the end of treatment ] [ Designated as safety issue: No ]
Investigator's and patients' rating of overall improvement and the patients' opinion on cosmetic acceptability [ Time Frame: End of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	84
Study Start Date:	January 2008
Study Completion Date:	June 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Azelaic acid 15% foam	Drug: Azelaic acid 15% foam to be applied topically twice daily
2: Placebo Comparator Vehicle	Drug: Vehicle Active-ingredient free vehicle to be applied topically twice daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules
Ability and willingness to accept and comply with treatment and required medical examinations

Exclusion Criteria:

Known non-responders to azelaic acid
Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea
Presence of dermatoses that could interfere with the rosacea diagnosis
Treatment with isotretinoin in the six months prior to randomization
Treatment of the face with topical retinoids during the two weeks prior to randomization
Treatment with oral antibiotics during the four weeks prior to randomization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617903

Locations

United States, Nevada
James Del Rosso, DO
Henderson, Nevada, United States, 89052

Sponsors and Collaborators

Intendis GmbH

Investigators

Study Chair:

Klaus Graupe, PhD

Intendis GmbH

More Information

Additional Information:

for drug information provided by the FDA This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Intendis GmbH ( Dr Klaus Graupe )
Study ID Numbers:	1402140, IND 77,516
Study First Received:	January 22, 2008
Last Updated:	July 22, 2009
ClinicalTrials.gov Identifier:	NCT00617903 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Intendis GmbH:

rosacea
papulopustular
azelaic acid
foam

Study placed in the following topic categories:

Rosacea
Azelaic acid
Skin Diseases

Additional relevant MeSH terms:

Rosacea
Azelaic acid
Skin Diseases
Antineoplastic Agents

Therapeutic Uses
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009