ISOTRETINOIN GEL ----------------------------------------- Does anyone have experience in using isotretinoin 0.05% gel (isotrex - Stiefel)? I am interested intreating a 52 y.o. male with sebaceous hyperplasia with normal serum lipids. He failed 6 months of topical Retin-A liquid, 0.05%. He does not want cryosurgical destruction, eletrodessication, shave excision, ultrapulse CO2 resurfacing, etc. Isotrex is available in Europe. Ethan D. Nydorf, M.D. ---------------------- I've used lots of Isotrex gel and I don't think it will work for sebaceous hyperplasia any better than vitamin A acid. I'd be interested to try adapalene (Diffrin) gel, a selective beta- and gamma- RAR (retinoic acid receptor) agonist. This makes it LESS likely to cause dryness, but I'd still like to try it. This is going to marketed by Galderma in Canada in a few weeks, and is already available in France. Another approach might be to try to get a selective alpha-RAR agonist to play with. I don't know anyone who has this, but I expect it exists in a lab somewhere. KC Smith MD FRCPC ------------------ Isotrex is basically Accutane in a light protective sunscreen base. You can get the same effect by opening an Accutane capsule with a needle, applying the yellow oil directly on the papules and cover with a high spf sunscreen. Or simply have the patient apply the accutane oil just before bed each night. If any oil is left in the capsule refrigerate and keep the cap covered with aluminum foil. Haines ELy ---------- Here in Canada (closer to you than Europe) we have had isotrex available for some time. I have used it in acne and frankly don't see any significant difference from topical tretinoin. The gel is at times too irritating for some patients. I have never ordered blood work for these patients but I don't supply it to pregnant women and advise sexually active females that they should not get pregnant while using this preparation. I think that the chance of this or any other topical agent affecting sebaceous hyperplasia is low to nil. Jason Rivers ------------ Isn't anyone concerned about teratogenicity when the Accutane oil is applied to the skin.? The patient described was a male but this opens the possibility for misuse or what ? We have been very interested in using the retinoids in cream bases for various diseases but Roche seems reluctant. Stiefel might have more experience? Jon H Olafsson MD PhD --------------------- This must be a consideration, and the discussion will probably mirror that around tretinoin topical. Evidence has shown that topical tretinoin is absorbed to such a small degree that it is undetectable by whatever assay was used. Some of my colleagues have criticized me for my conservative approach, which is to avoid using tretinoin topical during pregnancy. I avoid it because there are case reports of abnormal ear formation in babies of women who used tretinoin topical early in pregnancy, and I would not enjoy being thought the person responsible for this, much less the litigation. Tretinoin topical may be used during lactation. Barbara R. Reed, MD -------------------- If it has an "teratogen" or "x" label in the package insert, don't use it. Otherwise that malformation, even if one of those "random bad luck events" can be blamed on the prescriber. Rjshar@aol.com -------------- Isotrex gel is available in Canada, and I have been using it for the last few years. It is surprisingly well tolerated for acne patients, in my experience, in fact, far more than Tretinoin gel at 0.025 and 0.05. I have used it in several patients with past histories of acne, and very oily skin, with many scars. One in particular had a remarkable reduction in his sebaceous hyperplasia, subepidermal skin cysts, and punctate scarring; he has an overall "cleaner, smoother" complexion, and he is very happy. In contrast, I have had a few patients intolerant to it. However, there are fewer complaints if you go gradually, first to a maximum of tretinoin cream 0.1. Then if the patient tolerates it without irritation, I may try the Isotretinoin gel, if the patient feels that progress had slowed down. Oh, and by the way, it is quite helpful in the management of HIV positive patients with molluscum contagiosum. I have found that it reduces significantly the number of new lesions, and in some patients, there is actually synergistic efficacy with recurrent liquid nitrogen treatments to reduce the number to one which is cosmetically acceptable to the patient. More so than with Liquid nitrogen alone. Warren Winkelman, MD, FRCPC --------------------------- We were one of the Phase III sites for the topical isotretinoin photodamage studies done by Roche in 91 or 92 I believe. As a therapy for photodamaged skin, our impression was that it was effective on the order of tretinoin, but I have never seen the data completely synopsized anywhere. My guess (and it's a true guess) is that the FDA negative sentiment towards retinoids, combined with a negative attitude towards cosmetically-targeted drugs led Roche to conclude further development was not indicated. I am likely wrong: anyone out there from Roche or the FDA who could comment? Of course we were unable to use it for any other indication so can't directly comment on your questions. However, my understanding is that preliminary evidence suggests it functions for acne very similarly to tretinoin (in fact a JAAD article years ago showed that most of the isotretinoin was metabolized to tretinoin after topical application) and therefore one did NOT see isotretinoin-like effects such as sebaceous gland atropy. Mark Ling, M.D., Ph.D. ---------------------- Haynes: you're saying that topical isotretinoin had FDA approval for treatment of acne in the US? Do you know when this was obtained, and where the source data were published? I'm surprised, since we were never aware of this doing the top. isotret. studies for wrinkles, but I miss important facts every day! Mark Ling, M.D., Ph.D. ---------------------- Here in the Philippines Isotrex has been around for several years. Mainly we have been using it to treat acne and sometimes keratosis pilaris. The indication for this basically up to the dermatologist. However based on our experience we don't find it as effective as tretinoin. Filipinos generally have oily skin and some prefer to use a gel base vs a cream base for its drying effect. (We generally don't have a pharmaceutical company marketing tretinoin in a gel base). Because of its weaker effect I don't think it will work on sebaceous gland hyperplasia. EDC would be easier and results are immediate. Jonthan Yu, MD --------------- I agree with Dr Rivers. Isotrex has been heavily promoted in Australia for the last few years. Its effect on acne is no where near as impressive as oral isotretinoin. In my experience, it is only effective in a 20-30 % of patients with comedonal acne. I very much doubt its efficacy in sebaceous hyperplasia. Ken Ho ------ Unfortunately topical accutane does not suppress sebaceous function in the slightest. It does no more than Retin A for acne. Guy Webster ----------- At the Derm Update in Montreal in October 95 S. Jablonska reported on a European trial of Isotrex for actinic damage and as I recall Isotrex was just as irritating as VAA, but less effective. I still have a couple of women with DLE on the eyelids and forehead doing well with Isotrex daily or bid (must be several years now) - flares if they stop it. I tried it because there were some reports of Accutane working in DLE. These successes have been on very thin skin (eg. eyelids) - fails when tried on thicker skin with DLE. I have it on good authority that adapalene gel (Difrin) from Galderma will be helpful for actinic damange, and better tolerated than VAA. KC Smith MD FRCPC -----------------