V-101 (Oxymetazoline) starting Dose-Finding Trials

Written by David Pascoe on August 23, 2010 in clinical trials, New Rosacea Treatments, Oxymetazoline, Red Face of Rosacea with 0 Comments

Hot on the trail of the Phase 1 Study Results and Funding Announcement is a listing confirming that Vicept Therapeutics are soon to start dose finding trials for the treatment of the redness of rosacea.

The trial will study the efficacy of V-101 Cream, applied once per day, at a low dose of 0.01%, 2 lots of mid-dose of 0.06% and 0.1%, as well as a high dose of 0.15%.

The active ingredient in the formulation has not been officially disclosed, but a reasonable guess is that the active is oxymetazoline. The patents held by the company suggest that oxymetazoline is a primary active of interest, and further confirming the active ingredient is an exclusion criteria for this trial that precludes the “use of products containing oxymetazoline within 14 days of baseline”.

Oxymetazoline is the active ingredient in over the counter products such as Afrin, Vicks Sinex and Visine. The potential side effects of oxymetazoline when applied topically include rebound redness, hypertension and palpitation.

It will be interesting to see how well oxymetazoline performs in a double blind trial as well as get an understanding of any rebound redness and also whether any rebound redness occurs when continuing to use oxymetazoline after having a break.

Here is a short extract of the just announced trial;

Dose Response Study of Patients With Erythematous Rosacea
The purpose of this study is to evaluate the dose-response relationship (effect) of four concentrations of V-101 Cream in patients with erythematous (redness) rosacea.