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Monday, January 24, 2011

PR: ERSP Reviews Advertising for Dentagen's 'Proginicin;' Recommends Marketer Discontinue Claims at Issue

The Electronic Retailing Self-Regulation Program (ERSP) has recommended that Dentagen Distribution, LLC discontinue claims in direct response advertising for “Proginicin Oral Multi-Indication/Cold Sore Treatment.”

ERSP, the electronic direct-response industry’s self-regulatory forum, is administered by the Council of Better Business Bureaus (CBBB) with policy oversight by the National Advertising Review Council (NARC).

The marketer’s advertising came to the attention of ERSP following an anonymous challenge.

ERSP reviewed online advertising for the product, which was targeted to dentists and oral hygienists, and identified a wide range of claims for review, including:
  • “…PROGINICIN, a treatment for gum disease and dental procedures based on the ingredient, Viracea.”
  • “PROGINICIN is indicated for use on any sore or infection in the oral cavity including herpetic lesions. Reported results are remarkable when used on all grades of gingivitis.”
  • “PROGINICIN can be used on cold sores. Patients report that PROGINICIN is effective in preventing some eruptions, and reduces discomfort after blistering.” 
  • “PROGINICIN is also indicated for use on gingival cuts, abrasions, herpetic lesions (including cold sores), and all grades of gingivitis, including ANUG.”
  •  “PROGINICIN is outstanding as a treatment for gingivitis. YOU AND YOUR PATIENTS WILL BE AMAZED AT HOW QUICKLY IT WORKS!”
  • “PROGINICIN may relieve cold sores symptoms. When used at the first sign of an eruption, it may prevent the eruption and painful blistering.”
  •  “The wound healing period for ulcer sores was shortened by the same amount of time with implant patients.”
  • “With treatment of PROGINICIN the period to achieve healing ranged between 3 to 5 days. Usually it takes 7 to 14 days to achieve the same grade of healing.”
  •  “Usually, gingivitis symptoms might be improved after one week, with correct dental hygiene using toothbrush and dental floss. However, with the use of PROGINICIN the main aspects of gingival inflammation, including pain, gingival bleeding and swelling disappeared in one day.”
  • “Gingivoplastic surgery is a common procedure for patients with hyperplasic gingiva. This intervention causes an inflammatory process which can be largely improved by the application of a few drops of “PROGINICIN.”
  • “The present report showed that the main aspects of mouth soft tissues inflammation including pain, gingival bleeding and swelling were largely improved in a shortened time, by the application of a few drops of “PROGINICIN,. In addition, with treatment of “PROGINICIN, the period to achieve healing was noticeably reduced, demonstrating that it is an effective treatment option.”
  • “I saw a female patient with periodontal abscess on the mesial facial of #4. I debrided the periodontal pocket and was able to slip the thin neck of the “PROGINICIN applicator under the tissue. I slowly irrigated with “PROGINICIN. Two days later the swelling was gone and the periodontal abscess was totally resolved. I know of no other product that would do this.”
  • “I can heartily recommend “PROGINICIN for the eradication of any type infected wound in and around the oral cavity.”
As support for the claims at issue, Dentagen provided ERSP with a randomized, double-blind, placebo controlled, multi-center clinical trial for a product called RELEEV, which shares the same active ingredient – Viracea – as Proginicin. The primary purpose of the clinical trial was to determine whether RELEEV was effective as a topical treatment of the herpes simplex virus. One hundred fifty-seven (157) subjects between the ages of 18 and 65 completed the study. The authors of the study concluded that when used as directed, RELEEV relieved the symptoms of cold sores and was shown to be a safe and effective treatment of recurrent herpes simplex infection when compared to placebo.

(Full text of decision available to media, upon request)

ERSP questioned in its decision whether the study’s results could serve as support for the advertising claims made for Proginicin. ERSP noted that while the products share the same active ingredient, Dentagen did not confirm that Proginicin contains the same amount of Viracea contained in RELEEV or offer evidence regarding other ingredients in Proginicin that could offset the effectiveness of the Viracea ingredient.

Further, the RELEEV study was limited to the treatment of facial cold sores, not lesions inside the mouth.

In the absence of any reliable evidence to support these express claims, ERSP recommended that the marketer discontinue all of the claims at issue.

The company, in its marketer’s statement, said “…we are in the process of reviewing our advertising for Proginicin and will use our best efforts to implement the recommendations provided by ERSP.”

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