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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT00617903
First received: January 22, 2008
Last updated: March 21, 2012
Last verified: July 2009
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
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
Experimental: 1
Azelaic acid 15% foam
 Drug: Azelaic acid
15% foam to be applied topically twice daily
Placebo Comparator: 2
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
ClinicalTrials.gov Identifier: NCT00617903     History of Changes
Other Study ID Numbers: 1402140, IND 77,516
Study First Received: January 22, 2008
Last Updated: March 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Intendis GmbH:
rosacea
papulopustular
azelaic acid
foam

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Azelaic acid
Dermatologic Agents
 Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013