Randomized placebo-controlled trial of a flavonoid-rich plan

[prryjones]

Journal of the European Academy of Dermatology & Venereology
Volume 0 Issue 0 - July 2005
doi:10.1111/j.1468-3083.2005.01248.x


ORIGINAL ARTICLE
Randomized placebo-controlled trial of a flavonoid-rich plant extract-based cream in the treatment of rosacea
D Rigopoulos*, D Kalogeromitros, S Gregoriou, JM Pacouret, C Koch, N Fisher§, K Bachmann§, M Brown§, E Schwarz§, E Camel¶, A Katsambas

ABSTRACT

Background Biological research suggests that vascular changes may play a major role in rosacea pathogenesis. Chrysanthellum indicum is a plant-based extract containing a unique combination of phenylpropenoic acids, flavonoids and saponosids, and has a well-documented effect on vascular wall permeability and increase of the mechanical resistance of capillaries.

Objective To determine the efficacy and safety of a cream containing 1%C. indicum extract with vitamin P properties in the treatment of rosacea.

Methods This study included 246 patients diagnosed clinically as having moderate rosacea. Patients were randomly allocated to C. indicum extract-based cream (n = 125) and placebo (n = 121) groups. Patients were advised to apply the products on their face twice a day for a 12-week period. The patients were examined at the end of each 4-week period. Severity of erythema (graded by reference to six photographs), surface of erythema and rosacea overall severity scores were recorded at each visit on days 0, 28, 56 and 84. Investigators carried out a final efficacy assessment at the end of week 12. Volunteers' final overall efficacy assessment was recorded in a self-administered questionnaire. Adverse events were identified through examination, interview and collection of comments in patients' questionnaires.

Results Treatment with the C. indicum extract-based cream resulted in significant improvement (P < 0.05) in severity of erythema, overall rosacea severity compared to baseline and placebo, and investigator and patient overall efficacy assessment scores (P = 0.046 and P = 0.001, respectively) compared with placebo scores. Adverse reactions were mild, and did not differ between the C. indicum extract-based cream and the placebo groups.

Conclusion Chrysanthellum indicum extract-based cream is an effective and well-tolerated topical agent for the treatment of moderate rosacea. The mode of action of the active ingredient suggests that additional efficacy might be expected from combination with other topical treatments.

[Max]

again, thanks for your valueable inputs, good stuff.

since this is an abstract? i also wonder if one has access to full report it would also list ingredients used e.g. for cream? isn't such a procedure scientific standard to get reproducable results?

just a thought - does anybody know?

[prryjones]

Hi Max,
The link is below. You can order (purchase) the whole article, but I am sure the extract was formulated in the lab and is not yet commercially available as a topical.
These OTC's are dubious in my opinion...I'm waiting for SansRosa.
Perry



http://www.blackwell-synergy.com/doi...3.2005.01248.x

[todmiller]

Thanks for sharing these articles, Perry. Great stuff. We appreciate it.

I wish they would announce these studies so that we would know that they are going on, while they are in progress vs. afterwords. It would lift my spirits just knowing that research is indeed being conducted. But thanks for sharing the results. I'll take what I can get! =)

[prryjones]

Hi Todd,
Thanks, but it was nothing. Just either do a Google search or go to PubMed and enter rosacea, angiogenesis, erythema or another suitible word and you get all kinds of hits.
I think that most studies aren't put "online" until after they are published, and they arent usually published unless significant results - either pos or neg. are attained. Dr. Nase would be the one to ask this. It is indeed an excellent question.
I have some extremely bright friends (Indians...PhD students and their PhD mentors) working now on a version of a liposomal delivery system (you may recall that Dr. Nase has already mentioned one such system that has already been patented). If they are able to do this (its pretty complicated stuff...I mean these guys LIVE in the labs)... they will publish results which I am sure will be made electronic.
So, I would not be surprised if this is basically how it works.
If I ever find a link or way to view studies in progress, I will post.
Also, you can go to the FDA website to get a listing of all clinical trials currently being done, as well as those currently being recruited.
Take care,
Perry