Inject-able botulinum toxin type A product changed the cosmetic treatment industry in a big way when it arrived in the market and now occupies the top position in number of treated cases among the cosmetic procedures.
Being a comparatively low cost and quicker procedure with no down time and not much pain or discomfort, it attracts people in big numbers. Yet, it is estimated that even this popular treatment attracts only a small fraction of people desirous of cosmetic treatment, as many do not like to be injected in the face particularly near the eyes or eyelids to remove wrinkles.
There are three producers of inject-able botulinum toxin type A products in America and there are no clearly defined figures of inter-changeability of their doses which govern the important properties of onset of therapeutic effect, spread, effect, duration and side effects of the drugs. As a result, the doctors and the patients usually get committed to one product only for the entire length of the treatment to avoid confusion and misunderstanding about the doses.
Now there is a topically applied botulinum toxin type A product undergoing later phases of trial, and if proven successful, the product promises to be a game changer in the market. The Revance Therapeutics has completed Phase II program of 11 clinical studies involving 553 patients who had their lateral canthal lines (crows’ feet) treated with their investigational topical product called RT001.
The results were reportedly successful with no significant adverse effects. It was reported that “there was no evidence of diffusion of the neurotoxin away from the target muscle and no effect on carnial nerves. The laboratory monitoring and the ECGs did not yield any evidence of systematic exposure.”
But at present, RT001 is considered to be suited for treating superficial musculature like crows’ feet and possibly for treating perioral and forehead wrinkles in future. The product smoothen out the skin by changing the pore size and since it can be kept limited within the superficial musculature, the superficial wrinkles in the eyelids and lips could possibly be treated in future.
It was stated that “the median duration of the therapeutic effect was 113 days. The response rate was up to 89% based on a stringent composite end point requiring a 2-point improvement as assessed independently by investigator and patients’
Revance has developed a proprietary process which allows transcutaneous flux of large medicinal pay load. In this case, a synthetic peptide carrier has protein transduction domains and backbone core which attaches to the neurotoxin molecules and plays the crucial task of transporting the drug to the target depth below the skin. It can also be set to reach different depths.
The topical drug require mixing of a viscous gel in a one-step applicator for treating the lateral canthal lines. The mixing and the application of the gel take a few minutes and it is to be left in place for a period of 30 minutes or so, which is yet to be finalised. It is then to be removed by a specific cleanser.
The investigational product RT001 is now to be taken through Phase III trials.
[Source: This write up is sourced from the article “Topical Botulinum Toxin Will Turn Market ‘Upside Down’ ” By: BRUCE JANCIN, Skin & Allergy News Digital Network published in Skin & Allergy News dated April 26 2012]