Mirvaso and Soolantra together like best buddies

soolantra-tube

Galderma is proposing a Stage 4 trial of 188 participants to demonstrate the effectiveness of Mirvaso and Soolantra used together in treating the redness and papules and pustules of rosacea.

The trial is looking for rosacea sufferers with between 15 and 70 papules and pustules and also a score of 3 or 4 in the Clinician’s Erythema Assessment (0=none, 1=mild, 2=moderate, 3=significant, 4=severe). Sufferers will be treating with Mirvaso in the morning and Soolantra in the evening, for a period of 12 weeks.

This somewhat clumisly named MOSAIC trial mirrors the post-marketing trials for Oracea that in 2010 sought to show the impact of Oracea treatment once available at a large scale (ORCA – Oracea for Rosacea: A Community-Based Assessment).

Given that we know that the real world is showing higher incidences of adverse reactions compared to the Phase 3 trials of Mirvaso, it will be interesting to see results of this Phase 4 trial.

Clinical Trial NCT02616250

MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea. (MOSAIC)

The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea.

Experimental:

Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% creamHalf group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.

Placebo Comparator:

CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream

Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.

Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.

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About the Author

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

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2 Reader Comments

  1. David Pascoe says:

    comment via email.

    “How do u get on this trial and is it uk or us based”

    In general it is difficult to get on a specific trial, but you can try by confirming the location (visit the link above – sometimes location is obvious and sometimes not) and contacting the organisers. Galderma have listed someone in France to contact.

  2. John widgett says:

    I’ll love to get onto one of these trails Iam sick of people saying to me have you been in the sun I’ve tried lots of creams and nothing works I hate walking around with a red face

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