At least 16 million Americans suffer from Rosacea, a chronic dermatological skin condition of the face involving persistent redness, flushing, inflammatory lesions and visible blood vessels. An announcement made today by Galderma Pharma S.A., reports positive top-line results from a Phase 2b trial regarding 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.

Joseph F. Fowler, M.D., Clinical Professor of Dermatology at the University of Louisville and a principal study investigator commented:

“Currently, there are no medical therapies with FDA approval to treat the persistent facial redness of rosacea. 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.”

CD07805/47 demonstrated rapid effectiveness in reducing facial redness during the trial, there was no evidence of tachyphylaxis or rebound and was evaluated as safe and well tolerated during the treatment as well as in the follow-up phases of the eight-week trial.

Phase 3 studies are currently ongoing and results will be published as soon as further data and analysis are available.

Rosacea, a chronic inflammatory disorder of the face, commonly occurs in fair-skinned individuals, especially of Celtic and Northern or Eastern European origin between the ages of 20 and 50, but is most common in men and women after 30. Women are usually more often affected than men. The characteristic skin lesions (redness, visible blood vessels, papules and pustules) appear on forehead, nose and cheeks.

Little is known about the pathophysiology of rosacea. It may be due to multiple factors, involving vascular reactivity, immune system responses, and follicular microorganisms. Many of the most cited pathogenic theories on the etiology of rosacea are based on abnormalities in cutaneous vascular homeostasis. These theories stem from the prominent transient and non transient facial erythema seen in the majority of rosacea patients. It is believed that the disease manifests itself though cutaneous vasomotor instability, commonly referred to as abnormal involuntary dilatation and reactivity of small subcutaneous resistance arteries. The causes of vasomotor instability in patients with rosacea are not known. The condition may be triggered through spicy food, alcohol, weather changes, sun, and hot showers and often have a negative impact on the patients’ social life. Intolerance to cosmetics is also very common as well as stinging, burning and sensitivity of the skin. In some cases, people’s eyes can become red, dry and itchy.

Written by Petra Rattue