BioPharmX developing topical Minocycline Gel 1%

Written by on September 13, 2018 in Antibiotics, clinical trials, minocycline with 2 Comments

biopharmx

A phase 2 trial for a topical minocycline gel for the papules and pustules of rosacea has just been listed. BiopharmX, the sponsors of the trial, suggest that the product BPX-04 has “good tolerability and promising efficacy in rosacea” and also showcases “the value of our anhydrous hydrophilic topical delivery system.”

The trial will compare the efficacy of BPX-04 against the inert vehicle, looking to see if a once daily application for 12 weeks can be proven to help improve rosacea symptoms.

Clinical Trial NCT03667222

Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea (PRISM)

This is a 12-week, multicenter, double-blind, randomized, two-arm, vehicle controlled study.

Subjects will be randomized 1:1 to BPX-04 minocycline topical gel 1% or vehicle.

This study will include approximately 176 randomized subjects with inflammatory lesions of papulopustular rosacea on the face, defined by an IGA score of 3 (moderate) or 4 (severe) at Baseline.

Subjects will be healthy male or female subjects aged 18 years or older. There will be up to 20 study sites in the USA.

Subjects will apply approximately 1 gram of topical gel once each day for a 12 week duration. They will come to the study site at Screening, Baseline, and Weeks 4, 8, and 12 or early termination (ET) for the protocol required efficacy and safety evaluations.

The topical minocycline race is on

Earlier this year we learnt about Hovione also trialing HY01,  a “proprietary formulation of crystalline minocycline base and oil-based excipients”.

Additionally Foamix is undertaking trials with their 1.5% Minocycline Foam, having completed Phase 3 trials this year. Foamix is hoping to become the “first FDA-approved topical minocycline treatment for moderate-to-severe papulopustular rosacea”.

So the race is well and truly on to be the first company to release a topical minocycline treatment for rosacea. Lets hope they all succeed and rosacea sufferers end up with a greater choice.

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

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2 Reader Comments

  1. Adam says:

    David, with the end of the vasoconstrictor line of treatment, I was wondering what other, if any, treatments in the pipeline have the potential to be a ‘cure’?

    Google failed to produce any results so I was just hoping you could catch me up on what’s happening.

    Regards

    • David Pascoe says:

      Hi Adam, even venturing to use the word cure is tricky because it immediately raises hope that something could be classified as such. I don’t see anything in the pipeline that could be anything close to a cure, sadly. You can be sure anything promising will get good coverage on the site though!

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