What's New in Acne and Rosacea

Hilary Baldwin, MD

Disclosures

April 29, 2016

Rosacea: New Drugs in 2015-2016

In 2015, we saw the introduction of ivermectin 1% cream (Soolantra®) for the treatment of papulopustular rosacea.[13] The phase 3 trials took on unusually severe patients (N=1371) and showed statistical significance vs vehicle at week 4 and a 64.9% reduction in inflammatory lesions at week 12. The tolerability profile was better than vehicle. In a year-long safety study, there was no tachyphylaxis but rather an increase in efficacy over time reaching 71.1% clear/near clear at week 28. In comparison to metronidazole 0.75% cream twice a day, ivermectin 1% cream showed superior efficacy, slightly better tolerability, and a longer time to relapse.

Azelaic acid 15% foam (Finacea Foam®) also received FDA approval in 2015.[14] In the phase 3 trials, there was a 32.1% and 43.4% success rate (grade 2 and clear/near clear) and a statistically significant reduction in inflammatory lesions. The product was well tolerated with application site pain (6.2% vs 1.5% vehicle), itch (2.5% vs 0.3%), dryness (0.7% vs 0.7%), and erythema (0.7% vs 0.9%). Although not evaluated in a head-to-head study, it bears reminding that the prior formulation of azelaic acid 15% gel showed a 29% incidence of stinging and burning. The new vehicle is a unique hydrophilic oil-in-water emulsion.

Notable Rosacea News

Rosacea in the news included a discussion of the serine protease KLK5 in facial skin. It was noted that KLK5, an enzyme in the cathelicidin pathway, is increased in facial skin of rosacea patients.[15] Patients can be separated into those with high and low levels of KLK5. Individuals who respond best to treatment have higher levels of KLK5. This may partly explain the efficacy of both azelaic acid and doxycycline in the treatment of rosacea.

Also discussed was a new study indicating that topical dapsone has antimicrobial activity in vitro.[16] In this study, it was shown that dapsone showed antimicrobial activity against Gram-positive cocci in vitro in concentrations that could be expected to be achieved with topical application. This finding could help further define the mechanism of action of topical dapsone in acne and the possibility of antibiotic resistance concerns.

The Rosacea Pipeline

The rosacea pipeline has two product candidates in development. Topical oxymetazoline 1% is an alpha-1 and alpha-2 adrenergic agonist that vasoconstricts superficial vessels responsible for background erythema in rosacea. A phase 2 trial and a long-term safety trial met their endpoint with highly statistically significant reduction in erythema and a favorable dermal safety profile compared with brimonidine. Phase 3 trials have been completed by Allergan,[17] and the new drug application has been submitted to the FDA. It was reported at the AAD meeting that in comparison with brimonidine, the onset of action with oxymetazoline is slower, with a more gradual return to baseline.

Omiganan is a cationic antimicrobial peptide, a first-in-class for rosacea, that is entering into phase 3 trials. In a phase 2 dose-ranging study (N=240),[18] it showed a dose-dependent reduction in inflammatory lesions. The 2.5% formulation resulted in a 40% reduction at week 9. Cutaneous tolerability was good.

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