Safety and Efficacy of Azelaic Acid Foam 15% in Papulopustular Rosacea
Summary
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 foam against foam alone.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Papulopustular Rosacea
Intervention
Azelaic acid foam 15%, Foam vehicle
Location
Boni Elewski
Birmingham
Alabama
United States
35294-5188
Status
Active, not recruiting
Source
Intendis GmbH
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01025635
- 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).
Fibrin Foam
A dry artificial sterile sponge of fibrin prepared by clotting with thrombin a foam or solution of fibrinogen. It is used in conjunction with thrombin as a hemostatic in surgery at sites where bleeding cannot be controlled by more common methods. (From Martindale, The Extra Pharmacopoeia, 30th ed, p648)
Antifoaming Agents
Agents used to prevent the formation of foam or to treat flatulence or bloat.
Foam Cells
Lipid-laden macrophages originating from monocytes or from smooth muscle cells.
Scavenger Receptors, Class A
A family of scavenger receptors that mediate the influx of LIPIDS into MACROPHAGES and are involved in FOAM CELL formation.
Clinical Trials
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.
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.
The purpose of this study is to evaluate the potential of Tazarotene Foam to induce a phototoxic reaction when exposed to UV and VIS light on skin of healthy volunteers.
This study will assess the potential of tazarotene foam to cause sensitization during a 48 hour challenge following 21 days of exposure on the skin of healthy volunteers.
The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.
PubMed Articles
The transition from three-dimensional to two-dimensional foam structures.
A two-dimensional foam consists of a monolayer of bubbles. It can be created by squeezing the more familiar three-dimensional foam between two parallel glass plates. We describe and explain the minimu...
On How Surfactant Depletion during Foam Generation Influences Foam Properties.
Although it is known that foaming a surfactant solution results in a depletion of the surfactant in the bulk phase, this effect is often overlooked and has never been quantified. Therefore, the influe...
About mechanism of foam stabilization by solid particles.
The main objective of the research was to study the properties of the foam and foam films stabilized by solid particles. The properties of the foam films were compared with the analogous ones of the e...
Foam, a promising vehicle to deliver nanoparticles for vadose zone remediation.
Foam delivery of remedial amendments for in situ immobilization of deep vadose zone contaminants can overcome the intrinsic problems associated with solution-based delivery, such as preferential flow...
Smart foams: new perspectives towards responsive composite materials.
Hold the foam! Smart foams with a tunable surface-to-volume ratio have numerous potential applications, including decontamination. Recently fatty acid aggregates, the stability of which can be tuned b...
