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Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea

2014-08-27 03:18:53 | BioPortfolio

Summary

This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Erythematotelangiectatic Rosacea

Intervention

CD07805/47, CD07805/47, CD07805/47, CD07805/47

Location

Burke Pharmaceutical Research
Hot Springs
Arkansas
United States
71913

Status

Completed

Source

Galderma

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:53-0400

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Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema of Rosacea

Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once da...

Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Persistent Facial Erythema

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PubMed Articles [40 Associated PubMed Articles listed on BioPortfolio]

Demodex and rosacea: Is there a relationship?

The objective of the study is to compare the frequency of Demodex on the eyelash follicle of patients with rosacea and referents without rosacea or ophthalmological disorders.

Increased risk of chronic kidney disease in patients with rosacea: A nationwide population-based matched cohort study.

Rosacea is a chronic inflammatory skin disorder. Inflammation and oxidative stress are involved in the etiopathogenesis of rosacea and chronic kidney disease (CKD). This study aimed to investigate the...

Thickness of carotid intima and epicardial fat in rosacea: a cross-sectional study.

Rosacea is a chronic facial skin disease associated with excessive inflammatory response to various triggers. Although some studies have supported the increased risk of cardiovascular diseases in rosa...

Cross-Sectional Survey of the Burden of Illness of Rosacea by Erythema Severity.

Rosacea is a chronic skin condition characterized by persistent central facial erythema. To explore the burden of illness of rosacea in US adults, a cross-sectional web-based survey was conducted. Par...

Comorbidities in rosacea: A systematic review and update.

Rosacea is linked to abnormalities of cutaneous vasculature and dysregulation of the inflammatory response. Recent reports on rosacea have shown a significant association with cardiovascular, gastroin...

Medical and Biotech [MESH] Definitions

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).

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.

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