RENOVA ---------------------------------------------------- I'm insulted that Ortho drug reps are trying to sell Renova as a new and unique Rx. The false publicity makes it a marketing triumph of the worst sort. The patent on Retin A expired about two years ago. Why are there no generics on the market to give Ortho some price competition? Philip Hughes M.D. ------------------ Is Renova the exact same thing as Retin-A .05% cream? If so, why didn't they go with the .025% cream, which is much less irritating? Daniel F Mitchell ----------------- Well, I certainly don't want to end up becoming the defender of the pharmaceutical industry, but I am concerned with the fairly consistently negative tone on this list towards new drug development. Let me also be clear that one of my activities here is to do industry-sponsored drug trials, so certainly take that into account in judging my comments. Regarding Renova,it is certainly true that the active compound itself is tretinoin, same as Retin-A. I am however surprised that dermatologists do not appreciate the fact that vehicle design/composition can be as important as the drug itself in determining drug efficacy. Topical steroids are certainly the best example of this: remember that the difference between mid-potency Valisone lotion and ultra-potent Diprolene ointment is purely due to vehicle, not the betamethasone. Clinical trial data suggest that the emollient vehicle used in Renova is significantly better than Retin-A's vehicle at minimizing irritancy, the main limiting factor when treating photodamaged skin with retinoids. If you don't believe that vehicle can make a difference, try substituting Retin-A 0.05% LIQUID for your patients currently using 0.05% cream! I am hopeful that Renova will also allow us to use tretinoin in an off-label fashion to treat acne patients otherwise unable to use Retin-A. Time will tell. I would hope though that if we are to judge drugs, we base our opinions on available "hard" data rather than just suspicion of the drug industry. From: Mark R Ling , M.D., Ph.D. ------------------------------- its my understanding that the substituted alpha hydroxy products do on both a clinical and biopsy basis the same thing that tretinoin does, without the photosensitization (and without the photo-carcinogenesis in animals). Steven D. Emmet, M.D. --------------------- Evidence to date does not meet the same standard of rigor with which the effects of tretinoin have been quantified. It is extremely difficult to objectively measure improvement: placebo effects are enormous both for patient and physician. That's why the FDA demanded such enormous efforts with clinical, photographic, and skin surface replicas, among others, before allowing the indication. Now in contrast, AHA's are not regulated by the FDA. What that means is that claims can be made with virtually no substantiation, other than gross misrepresentation where the FTC might actually step in. Realize too that the majority of published data have been produced by dermatologists with some stake in AHA's. Indeed some of the best-recognized proponents own, or consult for companies producing AHA's. Some, like Gene Van Scott, have done a good job of trying to look scientifically at the biology of AHA's, but there are no clinical studies to my knowledge which come anywhere close to the reliability of the tretinoin studies. Not to say that AHA's may be as effective, it's just that there is a real "bandwagon" effect that I think we as a profession ought to resist, until real data are available. BTW, I have no stake (stock, consulting, or clinical trial) involvement with Ortho/J&J. Mark R Ling, M.D., Ph.D. ------------------------ The thought was good but the example not accurate. Valisone and Diprolene have different active ingredients. Valisone is the 17 valerate ester and Diprolene is the 17,21 proprionate diester of the betamethasone nucleus. Nevertheless, your comments are correct about vehicles and products. I suspect that most readers of the list don't understand or agree with intellectual property laws, judging by the complaints. Edward Gomez M.D., Ph.D. ------------------------ My thanks to Ed for pointing out my error. Same point does still hold though. Mark R Ling, M.D., Ph.D. ------------------------ Although I am certainly no expert, it is my impression that AHAs particularly improve stratum corneum morphology, depth, properties and function, without the degree of effects that tretinoin demonstrates in re-ordered elastin and collagen dermal organization, and basal epidermal differentiation that, theoretically, might make tretinoin a better agent to prevent or reverse photodamage/photoaging and secondary carcinogenic effects (as it does in renal transplant pts, XP, EB, etc). Certainly there is room for much more rigorous data on AHAs, especially from those without conflict of interest, and additional effects and benefits of their use will probably become evident in the future. I have found the reps to be a mixed bag, many are just recordings of co. ads, some are idiots who do not understand their products, and a rare, valued few are able to help in their use, relate varied pro/con experiences, and get and give feedback from other MDs, the co., research. I have no relationship or interest in any pharmaceutical co., including J&J/Ortho, or AHA makers. David J. Altman, MD, PhD ------------------------ I spoke to the prof. relations dept. at Ortho yesterday. Their answer: The difference between Retin-A 0.05% Cream and Renova 0.05% is the "emollient base" of Renova, which is supposed to make it less irritating. They said that no studies had been done comparing the two products' efficacy for acne, nor the two bases for comedogenicity, etc. The FDA approval process for Renova was for non-acne indications, i. e. wrinkles, etc. I guess we're supposed to just try it out or do further clinical studies ourselves. GenadijS@aol.com ------------------ Good question about the patent issue. I have assumed that the patent on Retin-A solution expired, but that Ortho had a patent on the cream formulations that has not yet expired. Certainly generics will be coming along some day. Mark1105@aol.com ----------------- Concentration of the active ingredient is only one factor to consider when choosing a retinoic acid formulation for your patients. Most topical products are inefficient, in the sense that only a small proportion of the active compound gets into the skin. A relatively small change in the extent of skin uptake can represent a large difference in the percent absorbed. The makeup of the vehicle determines absorption characteristics to a major extent. This means that both positive physiological changes and negative ones, such as irritation, are a function of vehicle. When irritation is due to the drug rather than one of the other components, changing either drug concentration and/or vehicle characteristics is expected to impact drug effect and irritation in the same direction. The vehicle used for Renova is apparently significantly different from that used in Retin-A cream. Renova should be considered a product distinct from Retin A with unique characteristics until scientific testing shows otherwise. Joel Zatz ---------- The package insert on Renova states "Renova does not elliminate wrinkles, repair sun damaged skin, reverse photo-aging, or restore a more youthful or younger dermal histologic pattern". It also gives other bad news, such as unimpressive improvement of fine wrinkling, mottled hyperpigmentation, and tactile skin roughness, and warnings against using it for more than 48 weeks. It sounds like we better stick to Retin-A cream Any comments from anyone who did the studies on Renova? Yelva Linfield MD ----------------- Just one thought. I don't pretend to know why the new Retin-A product but, perhaps now we can get the insurance companies to pay for RA for adult female acne! MH Kay M.D. ----------- My understanding of RENOVA is that it is the same as Ret-A but in a different base making it more effective and at the same time much less irritating.......is this true? Peauski@aol.com --------------- My office nurse recently started nightly application of Renova cream on her face. Previous attempts at use of Retin-A 0.025% cream or Retin-A 0.01% gel resulted in erythema, burning, and stinging within 3 days and intolerance to even weekly application. The Renova cream is well tolerated. Has anyone else observed this phenomenon? My untested hypothesis is that she may be allergic to the antioxidant butylated hydroxytoluene which is an ingredient in Retin-A creams and gel, but not in Renova cream. My Fischer textbook on Contact Dermatitis says that allergy to butylated hydroxytoluene is uncommon, but I wonder how many people get patch tested to butylated hydroxytoluene, since it is not part of our "standard series" of patch tests. Among prescription creams, it is an ingredient in Elimite cream, Halog topicals, and brand name Synalar cream. Allergy would likely go unsuspected if those are the only topical prescription products that contain butylated hydroxytoluene. I wonder whether allergy to butylated hydroxytoluene may be more common than previously thought. Walter H. Wood, M.D. -------------------- Interesting comments: Isn't this the point with Renova? I agree this is likely an irritant dermatitis rather than allergic in the vast majority of cases, in part vehicle-determined, but also remember that retinoids appear to be intrinsically irritating to some degree topically. Because of this, vehicle design and ability to "emolliate" becomes critical. The degree of knowledge and sophistication needed to create such a vehicle is substantial, and the proof of whether Ortho's formulation chemists have done their jobs is how well-tolerated Renova is versus Retin-A. My point is simply that the creation of Renova may be clinically useful, and therefore may possibly represent more than just another pharmaceutical company "conspiracy" to sell more product under a different name. Mark Ling, M.D., Ph.D. Emory University Department of Dermatology Clinical Pharmacology Unit Atlanta, GA ----------- ------- 4.24.96