Anti-acne drugs in phase 1 and 2 clinical trials

ABSTRACT

Introduction: Despite the impressive increase of knowledge on acne etiology accumulated during the last 20 years, few efforts have been overtaken to introduce new therapeutic regiments targeting the ideal treatment of acne. The increasing emergence of microbial resistance associated with antibiotics, teratogenicity, particularly associated with systemic isotretinoin, and the need for an adverse drug profile, which can be tolerated by the patient, make the need of new pathogenesis relevant anti-acne agents an emerging issue.

Areas covered: A search for phase 1 and 2 acne treatment trials in the US National Institutes of Health database of clinical trials and the European Medicines Agency database with the key words ‘acne’ and ‘treatment’ was carried out, on 6 January 2017.

Expert opinion: The detected trials mostly investigate topical agents that may act via sebosuppressive effects, antimicrobial properties or anti-inflammatory actions. The compounds under investigation include olumacostat glasaretil, cortexolone 17α-propionate, stearoyl-CoA desaturase 1 inhibitors, agents affecting the melanocortin system, omiganan, and minocycline. Systemic studied anti-acne drugs include finasteride, biologics, low dose anti-inflammatory antibiotics, and leukotriene B4 inhibitors.

KEYWORDS:

• Acne
• drug development
• investigational drugs
• phase 1
• phase 2

Article highlights

• New targets in acne therapy are envisioned according to new findings in acne pathophysiology highlighted in this article.

• First new drug developments address seborrhea via the topical route.

• PPAR gamma is another target for topical drugs under investigation.

• Systemic drug development currently do not promise a real breakthrough, however, anti-inflammatory agents are in focus including those actions directed against leukotrienes which in turn influence PPAR´s and consequently proliferation and differentiation of sebocytes.

• Future developments on modulation of skin microbiota are on the horizon.

This box summarizes key points contained in the article.

Declaration of interest

H. Gollnick has served as a speaker, investigator or advisory board member for Meda, Mylan, Galderma, Novartis, Almirall, Merz, GSK, IMTM, Pierre Fabre, Vichy and Biomedics. C. Zouboulis and his department have participated in the studies NCT0161654, 2011-004998-83 and 2015-004765-90 and have performed laboratory research projects supported by Merz, Novartis and Pierre Fabre. C. Zouboulis has also received honoraria for scientific advice/lectures from Allergan, Critical Therapeutics, Dermira, Galderma, LEO, Merz, Mimetica, Novartis, Pierre-Fabre, PPM, Sol-Gel, Stiefel/GlaxoSmithKline and Xenon; and is the owner of relevant patent WO02089791. C. Dessinioti has received honorarium as a speaker and advisory board member for Galderma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This paper was not funded.