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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

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PubMed Articles [37 Associated PubMed Articles listed on BioPortfolio]

Treatment of erythematotelangiectatic rosacea, facial erythema, and facial telangiectasia with a 577-nm pro-yellow laser: a case series.

Various lasers have been used for the treatment of erythematotelangiectatic rosacea (ETR), facial erythema (FE), and facial telangiectasias (FT). The assessment of the treatments of all of these condi...

Global Epidemiology and Clinical Spectrum of Rosacea, Highlighting Skin of Color: Review and Clinical Practice Experience.

Among individuals with skin of color, rosacea has been reported less frequently than in those with white skin, but it is not a rare disease. In fact, rosacea may be underreported and underdiagnosed in...

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Rosacea patients often are burdened with embarrassment, social anxiety, and psychiatric comorbidities. The Patient Health Questionnaire 9 (PHQ-9) is a validated and reliable self-administered tool for...

Increased expression of IL-33 in rosacea skin and UVB-irradiated and LL-37-treated HaCaT cells.

Rosacea is one of the most common dermatoses of adults. Although the detailed pathophysiology remains unknown, it is thought that rosacea is caused by a consistently aberrant, innate immune response, ...

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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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