A Press Release today (Vicept are happy to generate publicity at every step of their development) touting more Phase II Study results for their Oxymetazoline based V-101 product. V-101 is a topical slated to treat the redness of rosacea.
The first Phase II trial results for V-101 were announced just 3 months ago.
It isn’t yet clear what Vicept Therapeutics have done with the commonly available active ingredient oxymetazoline to package it as palatable to the sensitive skin of rosacea sufferers.
This most recent study `was designed to optimize the concentration of V-101 Cream in preparation for Phase III clinical testing in patients with erythematous rosacea and to further characterize the duration of the clinical effect’.
The previous Phase II trial examined 4 concentrations but this latest trial evaluated 2 concentrations of the active ingredient in V-101.
Vicept Therapeutics are now pushing for a meeting with the FDA to seek permission to enter into Phase III evaluations.
Malvern, PA – April 19, 2011
Vicept Therapeutics, Inc. announced today positive results from a second Phase II clinical trial evaluating the dose-response relationship of two concentrations of V-101 cream, a topical cream for the treatment of Type I Rosacea (Erythematous Rosacea).
The results demonstrated a statistically significant improvement (p= <0.01) in the primary endpoint, a reduction in facial erythema or redness, over a twelve hour period versus placebo cream in patients with erythematous rosacea.
Further, V-101 demonstrated a safety profile similar to placebo cream. This is the second of two V-101 Phase II studies to achieve statistical significance in the primary endpoints.
Related Patents
See Vicept Therapeutics gets funding for V-101 for coverage of the Patents owned by Vicept relating to their Oxymetazoline based treatment.
What About Rebound Redness?
There is still a question in my mind about how in-development treatments like V-101 will deal with the possibility of rebound redness.
12 hrs. of freedom from redness! Which will be released first, Sansrosa or V-101?? The race is on.. this will really change the face of rosacea, no pun intended, it will give people their lives back, this will hold us over until something better comes out that can completely eliminate rosacea for 24hrs. and be 100% safe, something that treats the cause and not the effects of rosacea, stop it before the inflammation cascade begins. People should have plenty of hope now..
It is great to see that both V-101 and Sansrosa are moving forward. That can only be good news!
I would think that Sansrosa has a nose in front as it is backed by a large company who can push it forward and also manufacture and distribute it at-scale.
I am very interested in the phase III trials. I would love to be involved in the clinical trials of this exciting new product. Will be happy to send a CV. I am a board certified Dermatologist with years of clinical research experience.