New Findings on Alcohol-Rosacea Link

White wine and liquor may increase rosacea risk, according to a new study in the Journal of the American Academy of Dermatology. It is widely held that red wine consumption is linked to rosacea, but the new study points to other types of alcohol as the more likely culprits.

The study analyzed data from 82,737 participants in the Nurses Health Study II. Researchers looked at the nurses’ alcohol consumption, what type of alcohol they drank (regular or light beer, red or white wine, or liquor) and whether they had been diagnosed with rosacea, and then calculated the risk of developing rosacea based on the amount of alcohol consumed. Women who drank alcohol had an elevated risk compared to those who didn’t drink, and that risk increased as alcohol consumption increased. However, the increased risk varied based on the type of alcohol consumed, the study showed. Neither beer nor red wine were found to significantly increase the risk for developing rosacea. By contrast, white wine drinkers’ risk of developing rosacea increased by 14 percent for those drinking one to three glasses a month, and up to 49 percent for those drinking five or more glasses a week. The risk for liquor drinkers ranged from 8 to 28 percent, depending on the amount consumed.

The researchers noted that white wine and liquor contain high concentrations of alcohol but lack the flavonoids and other anti-inflammatory substances found in red wine. Despite its anti-inflammatory properties, however, red wine also contains other substances, like histamine and resveratrol, that may contribute to flushing in patients who already have rosacea, the investigators wrote.

Exactly how or even if alcohol consumption increases rosacea risk is not known, but investigators suggest that alcohol’s weakening of the immune system and widening of the blood vessels may contribute to the redness and flushing that occur when one develops the condition. Further research is needed to shed more light on the connections between specific types of alcohol and rosacea.

In 2016, the National Rosacea Society awarded one of the study researchers $25,000 as part of its research grants program to increase knowledge and understanding of the causes and other key aspects of rosacea that may lead to improvements in its management, prevention, or potential cure.

BioPharmX Reports Positive Topline Results of BPX-01 Topical Minocycline

BioPharmX Corporation’s topical minocycline for acne, BPX-01, achieved its primary endpoint in a phase 2b clinical trial. There were statistically significant reductions in non-nodular inflammatory acne lesions when compared to vehicle in both the 1 percent and 2 percent doses of BPX-01, the topline results show. BioPharmX continues to progress BPX-01 towards a phase 3 program based on these phase 2b results.

The absolute mean change in the number of acne lesions from baseline to week 12 for each arm was:

• BPX-01 2% (n=72), -15.4 compared to baseline
• BPX-01 1% (n=73), -15.5 compared to baseline
• Vehicle (n=74), -11.3 compared to baseline

The phase 2b study was a randomized, double-blind, three-arm, vehicle-controlled dose-finding study to assess the efficacy and safety of BPX-01 for the treatment of acne vulgaris. The multi-center study evaluated two concentrations of BPX-01 (1% and 2% minocycline) and vehicle in 226 subjects, aged 9 to 40, with moderate-to-severe inflammatory, non-nodular acne vulgaris. It also measured reduction in Investigator’s Global Assessment (IGA) as a secondary endpoint. This secondary endpoint was defined as the proportion of subjects with at least a two-grade reduction in IGA to clear “0” or almost clear “1.” The proportion that achieved this endpoint was 22.7 percent for BPX-01 2%, 16.0 percent for BPX-01 1%, and 17.1 percent for vehicle.

Although these secondary endpoint results were not statistically significant, BioPharmX observed in the BPX-01 2% arm a clear numerical trend compared to vehicle. While this trial was not powered for statistical significance for IGA, this endpoint was included to inform the design of the pivotal phase 3 program.

The company has not yet analyzed the safety data from the phase 2b study. There were no serious adverse events related to study treatment reported to the company by the investigators during the trial.

Foamix Announces Additional Phase 3 Trial for FMX101 for Acne

Foamix Pharmaceuticals is launching an additional Phase 3 trial for FMX101, a topical minocycline treatment, in moderate to severe acne. If the results are positive, this new trial is expected to form the basis for a New Drug Application, which the company plans to submit in the second half of 2018.

Foamix previously announced topline data from two double-blind, randomized, placebo-controlled Phase 3 trials (Trials 04 and 05) that had investigated FMX101in a total of 961 patients with moderate to severe acne. Patients had been treated with either FMX101 (minocycline foam 4%) or vehicle foam once daily for 12 weeks. A new analysis reflects the pooled data results for the co-primary endpoints from both trials and data from secondary efficacy endpoint analyses.

Co-primary endpoint—Absolute change from baseline in inflammatory lesion count at week 12:

• Trial 04: reduction of 14.16 lesions (-14.16) for FMX101 and reduction of 11.17 lesions (-11.17) for the vehicle
• Trial 05: -13.46 for FMX101 and -10.72 for vehicle
• Pooled Analysis: Absolute change in inflammatory lesion count was -13.79 for the FMX101, 4% treatment group and -10.94 for vehicle

Co-primary endpoint—Proportion of patients with Investigator’s Global Assessment (IGA) success at week 12:

• Trial 04: IGA treatment success for FMX101, 4% treatment group was 8.09 percent vs 4.77 percent in vehicle
• Trial 05: IGA treatment success for FMX101, 4% treatment group was 14.67 percent vs 7.89 percent in vehicle
• Pooled Analysis: IGA treatment success was 11.51 percent for FMX101, 4% treatment group and 6.34 percent for vehicle

Additional Phase 3 analyses found that the FMX101 met secondary efficacy endpoints as well.

To achieve the necessary statistical power, compared with the prior Phase 3 trials, the target patient enrollment number has been increased to 1,500. Patients will be randomized 1:1 to receive either FMX101 or vehicle foam once daily over 12 weeks. Co-primary efficacy endpoints and inclusion criteria will be consistent with the prior Phase 3 trials.

In related news, Foamix is also developing FMX103, minocycline foam 1.5%, for the treatment of moderate to severe papulopustular rosacea. Based on the outcome of the Phase 3 studies for FMX101 and the increase in the number of patients to be enrolled to the third Phase 3 trial in acne, the company has also increased the sample size for the two planned Phase 3 studies for FMX103. The sample size is being increased from 600 patients per trial to 750 patients per trial, for a total of 1500 patients across the two trials. As previously communicated, the company intends to commence the Phase 3 studies for FMX103 mid-year 2017.

New Exemption for iPledge Patients

According to a report in the American Academy of Dermatology’s Dermatology World Weekly, sponsors of the iPLEDGE program for patients being prescribed isotretinoin have updated a policy that required physicians to obtain a pregnancy test for female patients who have had a partial hysterectomy. According to the news report, thanks to advocacy efforts of the American Academy of Dermatology Association, a partial hysterectomy is now a qualifying exemption from the pregnancy test requirement.