New Changes to IPLEDGE ProgramIn late October, the FDA approved several changes to iPLEDGE to better accommodate patients and practitioners involved with the risk management program for isotretinoin.The newest changes to iPLEDGE include the following:

• The 23-day lockout period for females of childbearing potential has been eliminated. The exception to this is when the patient has the first prescription filled. With this requirement changed, female patients of childbearing potential will no longer be “locked out” of receiving isotretinoin for 23 days if they don’t fill their prescription within 7 days of their office visit.According to the FDA, the 23-day lockout period for males and females of non-childbearing potential was dropped from the iPLEDGE requirements in October of last year.

•  Females of childbearing potential will now have the 7-day prescription window linked to the date of specimen collection for pregnancy testing — rather than to the date of the office visit, which was previously the requirement.

• For males and females of non-childbearing potential, the prescription window has been extended from the previously mandated 7 days to the newly approved window of 30 days. This change will reduce the burden for patients who cannot become pregnant.

• The list of acceptable secondary forms of contraception has been modified to make it more flexible. Patients taking isotretinoin will now have the option to use condoms with or without spermicide as a secondary form of contraception. This requirement is in keeping with current guidelines from the Center for Devices and Radiological Health, the Centers for Disease Control and Prevention and the World Health Organization.

• Patient communication letter requirements have been relaxed. It will now be acceptable to include Medication Guide content, rather than the shorter Safety Notice in patient communication letters.

These changes are expected to take effect in late fall.  Lamisil Oral Granules Receives Approval for Tinea Capitis in KidsA new oral formulation of terbinafine hydrochloride (Lamisil) has been FDA approved to treat tinea capitis in patients 4 years of age and older.Lamisil Oral Granules are supplied in packets containing film-coated granules that should be sprinkled on a teaspoonful of food and swallowed. For tinea capitis, the treatment regimen is once a day for 6 weeks. The product’s manufacturer, Novartis Pharmaceuticals, claims the active ingredient, terbinafine, treats the infected scalp area, allowing the scalp to heal over a period of time. According to Novartis, data pooled from two clinical trials involving more than 1,042 patients treated for a median of 42 days, showed that Lamisil Oral Granules was generally well tolerated and was shown to be an important and effective alternative for the treatment of tinea capitis. This was especially the case with T. tonsurans infection, which is currently the most prevalent type of tinea capitis in the United States.Lamisil Oral Granules are expected to be available in 125-mg and 187.5-mg packets in U.S. pharmacies in January 2008. Ongoing Studies for Barrier’s Oral Broad-Spectrum Antifungal Agent “Promising” for OnychomycosisBarrier’s Therapeutics recently announced “promising” results from its ongoing study of once-weekly dosing of  pramiconazole, its oral broad-spectrum antifungal product candidate, in patients with onychomycosis of the toenails. Pramiconazole had previously demonstrated positive results in clinical studies in tinea pedis, tinea corporis, tinea cruris, tinea versicolor, vaginal candidiasis and seborrheic dermatitis.Preliminary FindingsResults from 18 patients at week 16 of the study, 1 month after completing once-weekly treatment for 12 weeks, indicated a marked onset of clinical improvement in total signs and symptoms (p=0.001) of onychomycosis as measured by nail plate thickening, discoloration and overall appearance of the affected toenail. In addition, 4 of 13 patients (31%) evaluated at 3 months post-treatment demonstrated both mycological cure and a significant decrease in clinical signs and symptoms of the affected toenail. Current data indicate the drug has been well-tolerated, and there have been no reports of drug-related serious adverse events. Future FindingsTo date no patients have reached the final evaluation visit at week 48, 9 months after the end of treatment.Final results for all patients enrolled in the Phase IIa trial will be presented at a future scientific meeting. n Five New Allergens Added to  T.R.U.E. TestAllerderm, the U.S. distributor of the T.R.U.E. Test Allergen Patch Test announced the approval and release of Panel 3.1. Now in addition to the 24 allergens included in Panels 1.1 and 2.1, the patch test clinician will have 29 of the most common contact allergens on the third panel.Panel 3.1 Allergens include diazolidinyl urea (Germall II) and (Germall 115), which are preservatives found in cosmetics;  budesonide and tixocortol-21-pivalate, which are corticosteroids; and quinoline mix, which is found in paste bandages, medicated creams and ointments.The only approved patch test diagnostic test in the United States, the T.R.U.E. TEST is ready to use and offers accurate and reproducible results. Clearance for TatooStar YThe FDA has given 510(k) clearance to Asclepion’s TattooStar Y, a Q-switched laser that emits the wavelengths of 1064 nm, 532 nm and 585 nm. The TatooStar Y is indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions, vascular lesions and unwanted hair. IN BRIEFPhotoMedex has been named… to Deloitte's Technology Fast 50 Program for Greater Philadelphia, a ranking of the 50 fastest growing technology, media, telecommunications and life sciences companies in the area, by Deloitte & Touche USA, LLP.Theodore A. Boutacoff was appointed…President and CEO of Iridex by its board of directors on which Mr. Boutacoff serves as Chairman. Iridex Corporation is a leading worldwide provider of therapeutic-based laser systems, disposable laser probes and delivery devices to treat eye diseases in ophthalmology and skin disorders in the aesthetics market.Allure Magazine Names Remergent DNA Repair Formula… the best Morning Anti-Aging Treatment at its Annual Allure Best of Beauty Awards. The product from AGI Dermatics, is a proprietary twice-a-day serum to encourage the skin’s DNA repair mechanism to self-correct, treat past damage, and resist future injury when used with a sunscreen.Ferndale Laboratories and Foamix … have entered into an agreement to jointly develop a non-steroidal foam for the treatment of atopic dermatitis. Foamix will be responsible for developing the foam formulations and Ferndale will have an option to continue definitive development and worldwide commercialization of the product.  Where Do Patients Say They Go for Advice About Acne Treatments?According to a new survey conducted by the American Acne & Rosacea Society, 89% of Americans aged 12 to 54 said that they would go to a dermatologist if they had acne. The survey, which gathered the opinions of more than 750 people, found that Americans aged 12 to 54 would seek information from the following:• Medical professionals (94%) — including the following:    • Dermatologists (89%)    • Pharmacists (76%)• 72% of people would seek information about acne medications from the following sources:    • Internet (59%)    • Magazine articles (36%)    • T.V. commercials (28%)    • Magazine ads (26%)• 66% would ask family members or friends:    • Family members (60%)    • Friends (52%).Survey respondents aged 12 to 17 were more likely than people in the aged 18 to 54 group to search for information about acne medications in the following ways:• T.V. commercials (39% vs. 26%)• Magazine ads (32% vs. 25%)• Family members (73% vs. 58%)• Friends (61% vs. 51%)However, adults were more likely than the teens to turn to the Internet for information about acne medications (60% vs. 50%).