Galderma wanting to show Oracea Maintains Rosacea Remission

Written by on September 21, 2011 in clinical trials, Galderma, Oracea (40mg doxycycline) with 1 Comment


A recently posted proposed Clinical Trial has me thinking that Galderma wants to be able to market Oracea as a product to Maintain Rosacea Remission.

First Some History

In 1998, Archives of Dermatology published a much quoted paper Topical Metronidazole Maintains Remissions of Rosacea. (the PDF of the full paper is available online). The premise of the research was that for a majority of subjects studied, once rosacea symptoms (specifically their papules and pustules) were brought under control with oral tetracycline and topical metronidazole combined, the remission of symptoms could be maintained by the use of metrogel alone.

The 1998 study was funded by Galderma and the distinguished list of authors included academics and consultants paid by Galderma.

Note that Metrogel 1% was launched in the US in 2005, well after the 1998 trial that used Metrogel 0.75%, which at that stage was still protected by Galderma’s patents.

Oracea Maintains Remission?

This new trial will attempt to prove that Oracea is also capable of keeping the papules and pustules of rosacea at bay, once they have first been brought under control when treated in combination with Metrogel 1%.

The trial will also be able to confirm the safety of Oracea when used for a period of up to 1 year. Which pharmaceutical company wouldn’t want to be able to promote their profitable drug as effective and safe for such a long period?

Should this trial succeed Galderma will be able to market Oracea in new ways in the future.

Clinical Trial NCT01426269

Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea vs Placebo After 12 Weeks of Oracea and MetroGel 1%

The purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea during long-term treatment with either Oracea® or placebo, after an initial 12-week regimen of Oracea® and MetroGel® 1%.

Detailed Description:

Adult subjects with moderate to severe papulopustular rosacea will receive Oracea and MetroGel 1% once daily during phase 1 (baseline to week 12) of the study.

Subjects will be eligible to enter phase 2 of the study based upon improvements in the Investigator’s Global Assessment (IGA) score.

During phase 2, subjects will receive either Oracea or placebo once daily for up to an additional 40 weeks. Subjects who relapse during phase 2 will be discontinued from the study.

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About the Author

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

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1 Reader Comment

  1. Sue Ibrahim says:

    We have been prescribing Doxycycline 50mg daily to our patients. We find that this dose helps maintain the results achieved by Rosacea Phototherapy.

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