Who is sponsoring NCT00617903?

NCT00617903 is sponsored by LEO Pharma.

What condition does NCT00617903 study?

NCT00617903 studies Papulopustular Rosacea.

What drugs are being tested in NCT00617903?

Interventions: Azelaic acid, Vehicle foam.

What is the status of NCT00617903?

NCT00617903 is currently COMPLETED.

Last reviewed 2020-03-30 · How we verify

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

NCT00617903 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	LEO Pharma
Phase	Phase 2
Status	COMPLETED
Enrolment	83
Start date	2008-01
Completion	2008-06

Conditions

Papulopustular Rosacea

Interventions

Azelaic acid
Vehicle foam

Primary outcomes

Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward) — Baseline and End of Study (Week 12)
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF) — At End of Study (Week 12)
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).
Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) — Baseline and End of Study (Week 12)
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

Countries

United States