What's New in Acne and Rosacea

Hilary Baldwin, MD


April 29, 2016

Acne and rosacea garnered some attention at the annual American Academy of Dermatology (AAD) annual meeting in Washington, DC, last month. Discussions centered on new medications for both conditions released within the year, publications that shed light on the conditions, and a robust and exciting pipeline for the future.

Acne: New Drugs in 2015-2016

Adapalene 0.3%/benzoyl peroxide 2.5% gel (A.3/BP) (Epiduo Forte®, Galderma) was approved in 2015.[1] In phase 3 trials, 503 patients were randomly assigned to receive either A.3/BP, A.1/BP (Epiduo®), or vehicle (in a 3:3:1 ratio) daily for 12 weeks.[2] Patients were further stratified to assure a 50:50 ratio of moderate to severe patients. Success—clear/near clear and a 2-grade improvement—at the end of the trial was 33.7% (11.0% vehicle) for the entire group and 31.9% (11.8%) for the severe-only group, and absolute reduction in inflammatory lesions was -27.79 (-13.19) and -37.25 (-14.28), respectively.

Dapsone 7.5% gel (Aczone®) was approved just days before the start of the meeting.[3] Dosed once daily, as opposed to 5% twice daily gel, the new formulation was studied in the largest acne trial to date: 4336 patients with moderate-to-severe acne. The study also enrolled an unusually diverse population including 43% nonwhite patients. At 12 weeks, researchers observed a 55% reduction in inflammatory lesions in the treated group that was statistically significant compared with vehicle at week 2. The most common adverse events were dryness at 1.2% (1% vehicle), pruritus at 1.1% (0.6% vehicle), and pain at 0.5% (1.5% vehicle). A poster at the meeting noted that in a subcut of the data, women, particularly older women, responded better than the entire intent-to-treat population.

Notable Acne News

Selected publications discussed included the following:

  • Three patients with a history of pseudotumor cerebri were successfully treated with isotretinoin[4];

  • Evidence suggests that frequent laboratory testing for patients on isotretinoin was unnecessary if normal at week 8[5];

  • Potassium levels did not exceed baseline in healthy young women (N=974) on spironolactone ≤100 mg once daily for acne[6]; and

  • A study of 662 patients with moderate-to-severe acne were treated once daily with doxycycline 100 mg, doxycycline 40 mg modified-release, and placebo. At all time points, there was comparable efficacy and fewer reported side effects than with the 40-mg dose.[7]

The Acne Pipeline

The acne pipeline is particularly rich in 2016.

Sarecycline (Paratek Pharmaceuticals), a novel oral tetracycline, has completed phase 3 trials,[8] and stakeholders are cautiously optimistic for US Food and Drug Administration (FDA) approval in early 2018. A narrow spectrum of activity and once-daily, weight-based dosing have the potential to produce fewer side effects, reduce concerns about antibiotic resistance, and result in better efficacy than the currently available oral agents.

The nitric oxide gel SB204 (Novan Therapeutics) is a first-in-class topical agent for the treatment of acne. Nitric oxide, part of the normal host response to bacteria, is known to be a broad-spectrum antimicrobial. It also has anti-inflammatory properties, has been shown in a small pilot study to reduce sebum, and clinically appears to reduce hyperpigmentation. Novan's phase 2a (N=153) results revealed a dose-dependent reduction in inflammatory lesions reaching 55% at 12 weeks. In the phase 2b study, 213 subjects with moderate-to-severe acne were randomly assigned to receive SB204 4% once daily, SB204 2% twice daily, or vehicle for 12 weeks. Both dosing schedules resulted in significant reduction in the inflammatory lesion counts when compared with vehicle.[9] SB204 was well tolerated and is in phase 3 studies currently.

Two topical sebum reducers, Dermira's DRM01 (inhibitor of acetyl coenzyme A carboxylase) and Mimetica's MTC896 (melanocortin 5 receptor antagonist), have completed phase 2 studies demonstrating reduction in both inflammatory and noninflammatory lesions.[10,11]

Topical minocycline is being studied in a 4% foam (FMX101; Foamix Pharmaceuticals) and a 1% gel (BPX-01). BPX-01 (BioPharmX) 1% minocycline in a proprietary hydrophilic vehicle will soon begin phase 2 trials. The gel has been shown in preclinical studies to facilitate entrance of minocycline into the pilosebaceous unit despite its low concentration.[12]


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