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

Condition(s) targeted: Papulopustular Rosacea

Intervention: Azelaic acid (Drug); Vehicle (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Intendis GmbH

Official(s) and/or principal investigator(s):
Klaus Graupe, PhD, Study Chair, Affiliation: Intendis GmbH

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Nominal change in inflammatory lesion

Investigator's Global Assessment dichotomized into success and failure

Change in erythema rating on a four-point scale

Secondary outcome:

Absolute values and percentage change from baseline for the inflammatory lesion count

Absolute values and nominal change from baseline for the IGA of rosacea

Absolute values and rating changes of erythema and telangiectasia

Investigator's and patients' rating of overall improvement and the patients' opinion on cosmetic acceptability

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

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

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

for drug information provided by the FDA

Starting date: January 2008
Ending date: June 2008
Last updated: May 5, 2008