Exploratory Study of Azelaic Acid 15% Foam Compared to Vehicle in Patients With Papulopustular Rosacea
Summary
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Papulopustular Rosacea
Intervention
Azelaic acid, Vehicle
Location
James Del Rosso, DO
Henderson
Nevada
United States
89052
Status
Completed
Source
Intendis GmbH
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00617903
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Rosacea
A cutaneous disorder primarily of convexities of the central part of the FACE, such as FOREHEAD; CHEEK; NOSE; and CHIN. It is characterized by FLUSHING; ERYTHEMA; EDEMA; RHINOPHYMA; papules; and ocular symptoms. It may occur at any age but typically after age 30. There are various subtypes of rosacea: erythematotelangiectatic, papulopustular, phymatous, and ocular (National Rosacea Society's Expert Committee on the Classification and Staging of Rosacea, J Am Acad Dermatol 2002; 46:584-7).
Rhinophyma
A manifestation of severe ROSACEA resulting in significant enlargement of the NOSE and occurring primarily in men. It is caused by hypertrophy of the SEBACEOUS GLANDS and surrounding CONNECTIVE TISSUE. The nose is reddened and marked with TELANGIECTASIS.
Ambulances
A vehicle equipped for transporting patients in need of emergency care.
Povidone
A polyvinyl polymer of variable molecular weight; used as suspending and dispersing agent and vehicle for pharmaceuticals; also used as blood volume expander.
Chemoembolization, Therapeutic
Administration of antineoplastic agents together with an embolizing vehicle. This allows slow release of the agent as well as obstruction of the blood supply to the neoplasm.
Clinical Trials
Safety and Efficacy of Azelaic Acid Foam 15% in Papulopustular Rosacea
This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment papulopustular rosacea. The study will test the active ingredient plus...
To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.
Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma
The purpose of this prospective, randomized, controlled, single-blinded investigation is to study the efficacy, tolerability and safety of azelaic acid iontophoresis (AAI) versus topical t...
A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis
The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis.
Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea
The purpose of this study is to determine whether Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel are effective and safe in the treatment of papulopustular rosacea.
PubMed Articles
Rosacea: pathogenesis, clinical forms and therapy.
Rosacea is one of the most common chronic dermatological diseases. It is characterized by transient or persistent facial erythema, teleangiectasias, papules and pustules, usually on the central portio...
Rosacea : Systemic therapy with retinoids.
Systemic isotretinoin has been known for decades as an effective and safe therapeutic option in the treatment of severe and refractory forms of rosacea. It can also be used in special treatment-resist...
Background: Topical antifungals comprising imidazole derivatives have been used for the treatment of rosacea previously, owing to their anti-inflammatory activities. Terbinafine, an antifungal agent b...
Diagnosis and treatment of rosacea: state of the art.
Rosacea is a common disorder that is both under recognized and undertreated. Prevalence figures indicate that it may be present in 1 of every 10 adults in a primary care waiting room. Untreated, patie...
Rosacea and its ocular manifestations.
Rosacea is a chronic condition affecting the facial and ocular surface tissues. It is historically underdiagnosed and affects people of all ethnicities. The exact pathophysiology of rosacea is poorly...