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A sweet new solution for rosacea.

VIENNA -- A medical-grade topical honey product proved safe and effective for the treatment of rosacea in a randomized, placebo-controlled clinical trial, Brigitte Dreno, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

The product, known as Honevo, is a cream consisting of 90% New Zealand kanuka honey and 10% glycerine. It is applied twice daily as a face mask. Honevo is designed to wash off easily and is less sticky than honey.

The clinical trial, conducted in New Zealand, included 138 adults with rosacea who were randomized to 8 weeks of twice-daily application of the topical honey or cetomacragol, a nonionic, paraffm-based cream, as a control.

The primary outcome in the trial was at least a 2-point improvement from baseline on the 7-point Investigator Global Assessment of Rosacea Severity Score (IGA-RSS) as assessed by blinded investigators. This outcome, which reflects a clinical improvement from severe to moderate or from moderate to mild, was achieved in 34% of the Honevo group, compared with 17% of controls. Significant improvement in the honey group was seen after 2 weeks.

Rosacea resolved in 13% of the Hon evo group and in 3% of controls, based on a week 8 IGA-RSS of zero, noted Dr. Dreno, professor and chair of the department of dermatology at the University of Nantes (France).

The investigators from the Medical Research Institute of New Zealand and the University of Otago in Wellington observed that the study outcomes look at least as good as the results of placebo-controlled studies of topical metronidazole or azelaic cream. They plan to conduct randomized, head-to-head comparative trials of those prescription drugs versus Honevo, which is an OTC product.

The mechanism of action of kanuka honey in treating rosacea is believed to involve its previously reported antibacterial and anti-inflammatory effects, according to the investigators (BMJ Open. 2015 Jun 24;5[6]:e007651.).

The researchers noted that many rosacea patients aren't interested in long-term antibiotic therapy. They want a natural product that doesn't contribute to the global antibiotic resistance problem and is available OTC. Honevo is one of the few natural or complementary medicine therapies backed by data from a rigorous clinical trial, in this case one registered in the Australian New Zealand Clinical Trials Registry (AC TRN12614000004662).

Dr. Dreno wasn't involved in the study but included it in a talk in which she examined the strengths and weaknesses of current rosacea therapies. She is waiting for a confirmatory study before she incorporates Honevo in her own treatment algorithm. She said that she also would like to see studies examining whether combining the topical honey product with prescription drugs for rosacea provides synergistic efficacy.

HoneyLab, which funded the clinical trial and markets Honevo, ships the product to customers worldwide from its New Zealand headquarters.

bjancin@frontlinemedcom.com

COMMENTARY BY DR. HARPER:

Caution! Honevo, o medical-grade honey product, may have been shown to improve rosacea in this small study, but we cannot and must not compare results from one study to another study. It is not scientifically accurate for the makers of Honevo to say that their study outcomes look at least as good as the results of placebo-controlled studies of topical metroniaazole.

The study designs are completely different and comparing study outcomes is not appropriate. For example, the Investigator Global Assessment (IGA) score used in the Honevo study was a 7-point scale and the primary outcome was at least a 2-point improvement, not clear or almost clear. To be more specific, success was claimed if a subject dropped from severe to moderate or from moderate to mild. In pivotal trials of metronidazole (Metrogel) 1%, a 5-point scale (0-4) was utilized and most subjects started out as an IGA 3, or moderate. They were counted as a treatment success only if they achieved a score of 0 or 1 at the end of the study, not just if they improved. Comparing success rates makes no sense when success is defined so differently.

Dr. Dreno remarks that she is waiting for a confirmatory study before she incorporates Honevo into her own treatment algorithm for rosacea. I think that is the best approach.

BY BRUCE JANCIN

AT THE EADV CONGRESS
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Author:Jancin, Bruce
Publication:Dermatology News
Geographic Code:8NEWZ
Date:Jul 1, 2017
Words:695
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