Rossoseq for the Redness of Rosacea

Written by on August 20, 2012 in clinical trials, Red Face of Rosacea with 19 Comments

rossoseq

A new product known as Rossoseq is to be trialled as a treatment for the redness of rosacea.

The trial is sponsored by a company calling itself PBB Entrepreneur Ltd. and seems to be based in Germany.

60 people are to be enrolled in the trial, which is due to be completed by October 2012. The trial sites are 4 cities in Germany: Bochum, Duelman, Munster and Paderborn.

The 4 week trial will recruit 4 times as many women as men, and want rosacea sufferers to who score 6-15 for the primary and secondary features of rosacea.

Even though the study title mentions erythematotelangiectatic rosacea, the measurement for this trial will include “flushing, nontransient erythema, papules and pustules, telangiectasia and the secondary features burning or stinging, plaques, dry appearance, edema, ocular manifestations and phymatous changes during the office visits.”

What is Rossoseq?

Little information is available about the active ingredients in Rossoseq.

The product name has been trademarked and the trademark is owned by Pro Bono Bio Entrepreneur Limited. The domain name rossoseq.com is owned by Reading UK based Pro Bono Bio Ltd. The trademark and domain names have been created within the last year.

The product page for Rossoseq describes it as a product “formulated to distribute Sequessome vesicles into lower dermal tissues in the skin and is designed to treat conditions such as psoriasis.”

As more information becomes available this post will be updated.

Efficacy and Tolerability of Topical Rossoseq Compared to Vehicle in Rosacea Subtype 1 (Erythematotelangiectatic) (NCT01666509)

A Post Marketing Clinical Follow-up, Randomised, Double-blind Study Comparing the Efficacy and Tolerability of Topical Rossoseq With Vehicle in Rosacea Subtype 1 (Erythematotelangiectatic)

Rossoseq is registered for the treatment of inflammatory skin conditions. Rosacea is one such inflammatory skin disorder that has not been studied yet for the use of Rossoseq. Whilst rosacea is showing features of an inflammatory skin disorder [1], particularly stage 1 is poorly understood and treatment options are limited and therefore this study – within the target indication – will contribute to the learning about rosacea.

Male or female subjects ≥18 and < 85 years with a clinically diagnosed rosacea subtype 1 (erythematotelangiectatic) defined by a score of 6-15 for the primary and secondary features of the rosacea standard grading system (RSGS; Wilkin et al, 2004) will be enrolled.

The study will consist of a Screening visit, Baseline visit (Week 0), a telephone call at Week 1, visits at Week 2 and 4, and a follow-up telephone call at Week 5. Eligible subjects may or may not be using medication for their rosacea at the time of screening. Subjects with concomitant use of rosacea treatments will be taken off their current medication and will return for a Baseline Visit at the end of the wash-out period.

Eligible subjects will be stratified by gender at a ratio of 4:1 (Female: Male). Within the strata, subjects will be randomised at Baseline in a 2:1 ratio in favour of Rossoseq to receive either Rossoseq or vehicle.

Efficacy will be evaluated using subject rating of the rosacea specific quality of life instrument (R-QOL; Nicholson et al, 2007) during office visits and applied over the phone during the week 1 and follow-up telephone call at Week 5. An investigator rating will be performed using a “0=absent” to “3=severe” grading of the RSGS primary features flushing, nontransient erythema, papules and pustules, telangiectasia and the secondary features burning or stinging, plaques, dry appearance, edema, ocular manifestations and phymatous changes during the office visits. Ocular manifestations and phymatous changes need to be absent to be eligible for the study.

Photographs to document treatment effects will be taken at screening, baseline, week 2 and week 4.

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

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19 Reader Comments

  1. andy says:

    Some positive news on the redness front. Many trials and potential products, for what I consider the worst symptoms of rosacea. I quickly got rid of the lesions and bumps within 6months of being diagnosed. 3-4 years later I have mild redness barely noticeable but I would prefer to see it go and not have to use rosex, my mother is also a sufferer and needs to get rid of the redness

  2. Frank says:

    Is there any news on this? Maybe someone took part in the study?

  3. Andrea Porter says:

    *Rossoseq. Sorry for the typo!

  4. Frank says:

    How do you know?

    • Andrea says:

      Hi! I work in the pharmacy industry here in Ireland and stock has arrived with the distributor. Launch date to be set in the next couple of weeks. I suffer from mild rosecea and have been lucky enough to sample Rossoseq spray and am happy to say I’ve had a noticeable result within 7 days.

      Kind regards,

      Andrea

  5. Frank says:

    Thanks for sharing. Keep us informed! I’m looking forward now!

    Best regards,
    Frank

    • Paul O'Hea says:

      Hi Folks,
      We’ve been eagerly awaiting the launch of Rossoseq since we heard about it a few months ago, as it seems a really promising product! We will have it in stock in our pharmacies and on our website http://www.inishpharmacy.com in the coming weeks, so we will let you guys know when it is in stock for you and provide patient information on the product then also, and the before/after pictures when they are available to us.
      Best wishes,
      Paul

  6. Paul O'Hea says:

    Hi Guys,
    We have had a patient trialling Rossoseq for Rosacea now for over a month. Her results are very encouraging! Less redness across cheeks and nose areas in particular. If you want to see the before/after pics let me know. The product is first being launched in Ireland in the next two weeks.

  7. Emma says:

    My dad (who lives in Ireland) just sent me two rossoseq sprays and the exoseq tube. Tube very difficult to get stuff out of. It’s like foam. Spray much easier!!! Have just applied my first application. Can feel it on my skin and not yet sure how it will sit under make up. Guess I will know more tomorrow morning!!!! Very excited about the product and hope this will finally help me get my old face back!

    • Paul O'Hea says:

      Hi Emma, just to give you a bit of advice on the exoseq tube, it contains anninterior valve that allows exoseq to be dispensed in pinpoint drops…it is mor suited for small areas of application, such as above the hairline or for small plaques or acne. Its not really aimed at larger areas like rosacea covering areas of the face. Rossoseq spray would be better suited for that.
      Also, you need to give the products a couple of weeks to work. some people may see the benefit afetr a week but for others it may take 3-4 weeks. Indeed, one of our best ‘before/after’ trialling patients found the biggest benefit actually occured for her bnetween weeks 3 and 4. So it is worth giving it that time. This reason for this is that Rossoseq is not a masknig agent, like some of the camoflague type products on the market. Its the only clinically proven product to reduce actual skin redness. If you need any more information, before/after pics etc you can see them here on ouer website http://www.inishpharmacy.com/c/rossoseq-and-exoseq/448

  8. Emma says:

    Thanks Paul, Yep spray was much easier for use on my face and hands. Have some patches on scalp that tube might be okay for. Love the fact that this cream doesn’t mask symptoms and I will be patient! Day one face feels warm, make up went on really well over the application this morning and by this time my skin would be flaking so seems to have kept it mousturised really well.

  9. Paul has there been any publication of the results of the study NCT01666509
    Thanks
    Zbys

  10. Trish Lanney says:

    Hi All..I have severa rosacea I look like someone burned my face and I’ve tried everything on the market that I can think of and my mam has just bought me the Rossoseq spray I used it three times so far and two of those times was last night when I got up this morning my face is still red obviously as it takes a few weeks to work but the circle part of my cheeks were the redness is has gone smaller its not as red either but still quiet raw looking, I’ve read up on this product today and I really hope it helps me because at this point I am looking at getting laser treatment to help me I cant take the pain in the face, burning sensation or sore spots anymore…all I do is cover them up so I can go about my daily life even organic products don’t work for me so my skin cream is Elvave and then I am using this so fingers crossed if anyone wants pictures of my skin now please contact me don’t be shocked its awful and I will then do a progress one and an after picture. Thanks

  11. Patricia says:

    Checking back in I’ve been using the spray about 12 days now and I have to say I am not as impressed as I thought I would be it hasn’t really had much of an effect on my skin its still red and sore and I feel I get better results with Rozex steroid cream or even just Hydrocortisan cream you purchase over the counter.

    • Andrea says:

      Hi Patricia, I use Rossoseq myself and found it took a couple of weeks for it to really start working. Give it another week or so before you make up your mind. I can email my before and after pictures if you’re interested? Hope this helps.

      • Trish says:

        Hi Andrea, okay thanks for letting me know because I was getting a bit frustrated with it and not getting any results.
        Pix would be great please

  12. Sanela says:

    Any update on this spray? My rosacea is becoming hard to handle. Any advice

    • Andrea says:

      Hi. Rossoseq spray was rebranded and reformulated to sequaderma which is now a lotion. I’m still using it with good results for my mild rosecea. I still have the occasional flare up when I have red wine or during times of stress but for the most part, I’m happy with the product and the flare ups are much less frequent. I’m careful about what cleansing/moisturising products I use along with sequaderma. I have found the Seavite range by drs mulroony work well. They’re seaweed based which helps with my reactive Celtic skin type. Hope this helps.
      Kind regards,
      Andrea

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