Foamix to Trial Foaming Topical Minocycline (FMX103)


The prescription topical market for rosacea seems to be somewhat crowded. Sufferers have the choice of the metrogel family, finacea as well as the potential to try acne topicals such as retinoids. So far there hasn’t been a proven topical anti-biotic per se. Metrogel and Finacea have anti-inflammatory properties, but are not classified as anti-biotics.

Minocycline, as one of the tetracycline family may also offer some anti-inflammatory benefit to rosacea sufferers, but the question remains as to whether this benefit can be seen as a topical application. Minocycline is an unstable chemical and thus far has only been suitable as a systemic treatment – topical treatments have not been readily available.

Foamix are proposing to trial their foam technology with minocycline as a rosacea treatment.

Topical treatments need to penetrate the skin to access the cells that the active molecules target. Perhaps this form of application might provide an alternative method to relieve the inflammation associated with rosacea.

Certainly in order to show that foaming topical minocycline is a winner, Foamix will need to show that it is at least as effective as and indeed offer some benefit over metronidazole and azelaic acid.

Foamix promote the ease of application and the absence of alcohol in their products, suggesting that it is ideal for many dermatological agents

Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Rosacea Patients

This is a pilot phase II study to evaluate the tolerability and safety and to monitor the clinical efficacy of Topical Minocycline Foam FXFM244 in moderate to severe Rosacea patients.

A Pilot, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study. The study will involve three treatment groups. Eligible patients will be randomized to receive either FXFM244 – 1%, FXFM244 – 4% or Placebo, in a blinded fashion. Patients will be treated twice daily for 12 weeks. Following the screening period and baseline visit, study subjects will return at Weeks 3, 6 and 12. At each visit, patients will be evaluated via lesion count, global assessment tolerability and safety.

The trial will examine topical minocycline foam at strengths of 1% and 4% over a period of 12 weeks.

Update: During developent, this product is now known as FMX103, and since being approved by the FDA is known as Zilxi.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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1 Reader Comment

  1. sean says:

    Topical minocycline cream is very easy to make up and safer than oral admin which can have some rather nasty systemic side effects. Empty the capsules. Grind up the beads in a sturdy metallic pepper mill into a fine powder. Mix with cream E45. I use a w/w 10% cream. I also use Isotrexin, 10% Zinc Sulphate cream (made up from Zinc Sulphate monohydrate and E45.) and Zinc Oxide cream (Sudocrem). I never use oral retinoids and I have gradually weaned myself off oral minocycline. The mino cream is a browny yellow colour so you cannot wear it outside. You adjust the concentration according to your own needs. Each capsule contains 100mg (2 X 50mg beads) Minocycline. A tube of E45 is 50g. It is easy to calculate the concentration. Try it on test areas first for a week or so before using it on the face.

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