Rosacea » cutanix http://rosacea-support.org Where the rosacea community meets to support each other Fri, 20 Nov 2009 12:31:10 +0000 http://wordpress.org/?v=2.8.6 en hourly 1 cutanix goes offline, gets letter from FDA http://rosacea-support.org/cutanix-goes-offline-gets-letter-from.html http://rosacea-support.org/cutanix-goes-offline-gets-letter-from.html#comments Fri, 27 Apr 2007 01:09:00 +0000 Digital Davo http://rosacea-support.org/cutanix-goes-offline-gets-letter-from-fda.html

A few people have noticed that Cutanix seems to have vanished off the face of the internet. Their web sites at cutanix.com, tvdepot.com are offline, and their corporate web site at bioformmedical.com no longer even mentions Cutanix. Also the other regular online stores for Cutanix DRL at Amazon, DermaDoctor and Skin-Etc have no stock.

So what has happened to this much loved product ? I haven’t had official word from BioForm, but a recent letter from the FDA looks telling.

Warning Letter: FDA to BioForm Medical, Inc.

The FDA is strict about what medical claims can be made on product packaging. If a product makes claims pertaining to a certain disease it must have acceptable proof to back it up and permission to make these claims. The FDA only grants this sort of permission if the product makers sponsor a New Drug Application and it gets approved by the FDA.

I for one am certainly hoping that BioForm will be able to address the issues with the labelling and continue selling DRL.

It would seem that in order to no longer be classified as a drug, labelling will need to be severly `dumbed down’ so that no specific claims are made about the products applicability. Those who have followed the story of the FDA and Rosacea-LTD will know that it can take some time before the FDA is happy with a product’s labelling.

]]> http://rosacea-support.org/cutanix-goes-offline-gets-letter-from.html/feed 21 benzaldehyde reduces facial erythema http://rosacea-support.org/benzaldehyde-reduces-facial-erythema.html http://rosacea-support.org/benzaldehyde-reduces-facial-erythema.html#comments Wed, 05 Oct 2005 18:43:00 +0000 Digital Davo http://rosacea-support.org/benzaldehyde-reduces-facial-erythema.html 4-ethoxybenzaldehyde is the active ingredient (known as Quadrinone) in the Cutanix Dramatic Relief (DRL) line of products. This paper is published proof of the efficacy of the Cutanix products that contain Quadrinone.

Efficacy of 1% 4-ethoxybenzaldehyde in reducing facial erythema. Dermatologic Surgery, 2005 July, Page 881-885; discussion 885.

BACKGROUND: Facial erythema is a common postsurgical and dermatologic problem. It is commonly the result of dermal inflammation arising from either a facial surgical procedure, such as laser resurfacing, dermabrasion, or a face peel, or from an underlying dermatologic condition, such as rosacea. Facial erythema is difficult for the dermatologist to treat in both settings because topical corticosteroids cannot be used long term on the thin facial skin and anti-inflammatory oral or topical antibiotics have associated side effects.

OBJECTIVE: The goal of this pilot study was to evaluate the anti-inflammatory effect of 1% 4-ethoxybenzaldehyde in a rosacea model of facial erythema.

METHODS: Thirty subjects with mild to moderate stable rosacea were enrolled in this 4-week, double-blind, vehicle-controlled study. Photographs, investigator assessment, and subject assessment were the efficacy criteria.

RESULTS: There was a statistically significant reduction in facial erythema (p<.01) in those subjects who used the active for 4 weeks, as well as a statistically significant improvement in uneven skin tone (p<.01) and the overall severity of the disease (p<.01). There was no statistically significant difference in any of these three indices in the vehicle-treated group.

CONCLUSION: The results suggest that benzaldehyde-derived anti-inflammatory agents may be useful in reducing facial erythema in a rosacea model.

PubMed Abstract

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]]> http://rosacea-support.org/benzaldehyde-reduces-facial-erythema.html/feed 0 Cutanix DRL (Quadrinone) reduces redness http://rosacea-support.org/cutanix-drl-quadrinone-reduces-redness.html http://rosacea-support.org/cutanix-drl-quadrinone-reduces-redness.html#comments Wed, 05 Oct 2005 18:16:00 +0000 Digital Davo http://rosacea-support.org/cutanix-drl-quadrinone-reduces-redness.html

BioForm Medical, the owners of Cutanix Corporation, have announced that Quadrinone, the active ingredient in their products, is `4-ethoxybenzaldehyde’. Quadrinone is known to many in the rosacea community via the products known as Dramatic Relief Multi-Action Skin Therapy or (DRL).

This announcement accompanies the paper entitled The Efficacy of 1% 4-ethoxybenzaldehyde (Quadrinone) in Reducing Facial Erythema, where the effects of DRL were examined in a pilot study of 30 people with mild to moderate facial rosacea. Twenty of the study subjects were randomly selected to receive the DRL, which they applied to their face twice daily, while the other 10 subjects in the control group only received the lotion vehicle – without Quadrinone.

Dr. Draelos reported “that there was a statistically significant improvement in erythema (facial redness), uneven skin tone, desquamation (peeling) and overall severity of rosacea.”

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