In April 2011 we learnt that Vicept Therapeutics was undertaking some Phase 2 trials for their V-101 product. Now we see that Allergan, the new owners of V-101 are about to undertake some Dose Finding Phase 2 trials for the re-named AGN-199201.
Even though the 2011 announcement suggested that that trial 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”, more Phase 2 trials are to be taken.
Previous trials have examined 4 different concentrations and again 2 concentrations; this newly announced trial will examine 3 different concentrations against placebo. From this it would appear that the researchers are continuing to search for the best concentration to balance side effects with efficacy.
The trial record doesn’t detail the concentrations that will be examined.
The trial details suggest that 360 people will be recruited in Austin, Texas. This trial is scheduled to finish in November 2013.
What is Oxymetazoline?
Even though this trial doesn’t mention Oxymetazoline we know that that AGN-199201 is the code name for the oxymetazoline based product that Allergan purchased from Vicept Therapeutics.
Oxymetazoline is the active ingredient in decongestant products like Afrin, Sudafed OM and Vicks Sinex as well as in eye drops like Visine LR.
A well known side effect of Visine is rebound redness, where continued use leads to the redness that you were originally treating. Extended usage of Afrin can also lead to rebound nasal congestion.
Clinical Trial NCT01735201
ClinicalTrials.gov Identifier: NCT01735201
First received: November 26, 2012
Estimated Enrollment: 360
Study Start Date: December 2012
Locations: Austin, Texas, United States
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice daily compared to vehicle for the treatment of moderate to severe facial erythema associated with rosacea.
Primary Outcome Measures:
- Change from Baseline In Erythema as Assessed by the Clinician’s Erythema Assessment (CEA) and Subject Self-Assessment (SSA) 5-Point Scales [ Time Frame: Baseline, Day 28 ]
Secondary Outcome Measures:
- Change from Baseline In Erythema as Assessed by the CEA and SSA 5-Point Scales [ Time Frame: Baseline, Day 28 Hour 0.5 ]
- Change from Baseline In Erythema as Assessed by the CEA and SSA 5-Point Scales [ Time Frame: Baseline, Day 28 Hour 1 ]
- Redness of the skin caused by rosacea
- ≥3 inflammatory lesions
- Laser light-source or other energy based therapy in the last 6 months
- Any prescription or over the counter product for the treatment of acne or rosacea in the last 14 days
- Allergan Trialing Oxymetazoline for Facial Redness
- Allergan Developing Oxymetazoline (AGN-199201/V-101) Cream Formulations
- Allergan buying Vicept Therapeutics to get V-101 / Oxymetazoline
- Combine Brimonidine and Oxymetazoline, Why Not?
- Vicept Oxymetazoline V-101 Cream More Phase II Data, on to Phase III
- Oxymetazoline good for 6 hours and safe for 3 months
- Patents abound for treating rosacea with alpha agonists
- Oxymetazoline may be good for 2 years