Galderma Pharma SA, announced positive top-line results from a phase II b trial that evaluated the efficacy and safety of CD07805/47, a proprietary topical gel under investigation for treating patients with moderate to severe facial erythema (redness) of rosacea. Rosacea is a chronic dermatological condition of the face and eyes characterized by persistent redness, flushing, inflammatory lesions and visible blood vessels that affects at least 16 million Americans.

“Currently, there are no medical therapies with US FDA approval to treat the persistent facial redness of rosacea,” said Joseph F Fowler, MD, Clinical Professor of Dermatology at the University of Louisville and a principal study investigator. “The results of this study confirm CD07805/47’s potential to become a viable topical treatment option that could possibly help enhance the quality of life for the millions of patients affected by the persistent facial redness of rosacea.”

In the trial, CD07805/47 was shown to be rapidly effective at reducing facial redness. During the treatment and follow-up phases through the eight-week study, CD07805/47 was evaluated as safe and well-tolerated. There was no evidence of tachyphylaxis, or rebound, in the study. The results will be submitted for publication where further data and analysis will be provided. Phase III studies are currently ongoing.

The pathophysiology of rosacea is poorly understood and may be multi-factorial, involving vascular reactivity, immune system responses, and follicular micro-organisms. Many of the most cited pathogenic theories on the etiology of rosacea focus on abnormalities in cutaneous vascular homoeostasis. These theories are based on the prominent transient and non-transient facial erythema observed in a majority of patients with rosacea.

Disease manifestations are thought to arise from cutaneous vasomotor instability, the term commonly used to refer to abnormal involuntary dilatation and reactivity of small subcutaneous resistance arteries. The etiology of vasomotor instability in patients with rosacea is unknown. Triggers for the condition may include spicy food, alcohol, weather changes, sun, and hot showers, which often have a negative impact on the patients’ social life. Stinging, burning and sensitivity of the skin and intolerance to cosmetics are also very common, and in some cases, the eyes can become red, dry and itchy.

Galderma’s ambition is to be recognized as the most competent and successful innovation-based company focused exclusively on meeting the needs of dermatology patients and physicians.