Proving Sansrosa works as well as users think

Written by on June 26, 2013 in clinical trials, Red Face of Rosacea, Sansrosa with 5 Comments

A slightly unusual trial has surfaced at ClinicalTrials. The Phase 3 trial for Sansrosa seeks to prove that patients’ satisfaction with Sansrosa matches being treated with the active gel.

In short, the trial wants to prove that any improvement in facial redness perceived by the trial participant can be shown to be because of Sansrosa.

This seems to be more of a marketing outcome, rather than say a safety or more general efficacy trial we see more commonly.

Perhaps a successful outcome for this trial might lead to marketing claims like “Sansrosa, proven to make red faces sufferers happy”.

Clinical Trial NCT01885000

Patient-Reported Outcome Of Facial Erythema (PROOF)

The purpose of the study is to evaluate the patient-reported outcomes (feedbacks of patients)of a new drug for the treatment of erythema of rosacea (central facial redness).

The feedback of patients receiving the active drug will be compared to the feedback of patients receiving the placebo.

Sponsor: Galderma

Condition: Rosacea Erythema

Drug: once-daily brimonidine tartrate 0.5% gel vs. once-daily brimonidine tartrate vehicle gel

Estimated Enrollment: 80
Study Start Date: June 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: November 2013

Locations: Germany, Sweden and United Kingdom.

Update: we learnt in April 2013 that Sansrosa has been submitted for FDA approval.

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

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5 Reader Comments

  1. Sa818283 says:

    I am beyond excited for this drug to be approved. If it works and does not cause rebound flushing it will change so many people’s lives for the better. It will Probably be very expensive too.

  2. Henrik says:

    I really hope they have managed to prevent rebound flushing! This was a huge issue after I initially tried brimonidine. It sounds like the drug launch should be mid next year, as they are completing the final trial/survey, which appears to be for marketing purposes in February.

  3. Johnabetts says:

    This seems very odd to me – setting up a new clinical trial at this late stage to see if the product works against a placebo. To my mind it is the first clinical trial that should determine the viability of a product, not several trials down the line.

    Clinical trials are not cheap and seemingly to do so many before determining whether a product works or not strikes me something of desperation. Is the therapeutic effect of Brimonidine so small that they have still no statistical (or more realistically, patient in use evidence) that the stuff actually does something – and does it without unacceptable side effects?

  4. George says:

    Does this mean they are comparing a standard version of brimonidine tartrate to a modified vehicle gel?

    ‘Drug: once-daily brimonidine tartrate 0.5% gel vs. once-daily brimonidine tartrate vehicle gel’

  5. David Pascoe says:

    Hi George,

    Not a `modified vehicle’ gel, but a gel containing all of the ingredients except the active ingredient itself.

    This is a standard part of clinical trials – to prove that the product with the active is significantly better than without.

    Even the inactive vehicle gel can provide benefits – through improving hydration or offering some protection for example.

    A successful product is one that can prove the active is the real reason for benefits shown.

    dp.

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