Feature: Acne And Rosacea Update - By Stefanie Tuleya, Senior Editor News and recent research highlights. Topical Metronidazole: A Status Report A poster presented at the American Academy of Dermatology Summer Meeting in Chicago, reviewed data from recent clinical trials evaluating topical metronidazole gel (MetroGel), including the new 1% gel formulation and discussed the new vehicle formulation. Metronidazole 0.75% Gel (Aqueous Vehicle) A recent multi-center, open-label, 12-week trial (CLEAR Trial) evaluated 582 patients treated with metronidazole 0.75% gel for papulopustular rosacea, whose severity ranged from mild (19%) to moderate (58%) to moderately severe (23%). Mean inflammatory lesion count reduction, erythema score, investigator global assessment score and telangiectasia index score all improved significantly (p<0.0001) at each evaluation point (weeks 4, 8 and 12), with consistency of results observed across age and gender subgroups. At study endpoint, lesion count reduction was 71% at week 12, with 42% of patients rated by the investigator as clear or almost clear. The reported adverse reaction rate in the trial was <2% at week 12. Metronidazole 1% Gel (HSA-3 Vehicle) A recent formulation advance has made it possible to solubilize metronidazole 1% into a novel aqueous-based gel formulation using hydrosolubilizing agents vehicle technology, known as HSA-3. Clinical study results and 21-day cumulative irritancy testing have shown this new formulation to provide enhanced cutaneous penetration of active drugs, marked clinical efficacy and favorable skin tolerability. The HSA-3 gel formulates metronidazole into an aqueous vehicle with a combination of niacinamide, beta-cyclodetrin (Betadex) and propylene glycol, which is in a concentration significantly lower than that associated with skin irritation or allergy. A Phase II study compared the percutaneous absorption of metronidazole 1% gel (HSA-3 vehicle) and metronidazole 1% cream (suspension). The gel formulation demonstrated optimal penetration into the epidermis and dermis. A 2-week study of 25 adult females with mild to moderate rosacea showed that metronidazole 1% gel (HSA-3) does not increase transepidermal water loss in patients with rosacea, indicating no impairment of epidermal barrier function. The study also found that the formulation improves skin hydration based on corneometry testing. A 10-week, multi-center, double-blind, randomized, investigator-blinded trial found that metronidazole 1% gel (HSA-3) is significantly superior to vehicle alone in mean percentage reduction of inflammatory lesions, reduction in combined erythema severity score and improvement based on investigator global assessment. Signs and symptoms of disease such as dryness, scaling, stinging/burning and pruritus improved from beginning to study endpoint. Author: James Q. Del Rosso, D.O., F.A.O.C.D. Practical Approach to Treating Pediatric Acne In the last 30 years, dermatologists have developed a deeper understanding of the pathophysiology of acne. Recognition and differentiation between lesion type — comedonal and inflammatory — has begun to play a role in maximizing treatment options, including combination therapies. To prove the effectiveness of a sequential combination approach for treating acne in pediatric or adolescent patients, cases utilizing a sequence of therapy beginning with combination topical retinoid adapalene gel with the oral antibiotic doxycycline hyclate, and then transitioning to topical clindamycin 1%/benzoyl peroxide 5% gel and topical adapalene gel were reviewed. Patient One Patient: 18-year-old female with moderate comedonal lesions and severe inflammatory papules and pustules. Treatment: At baseline, she was started on doxycyline hyclate 100 mg q.d. and adapalene 0.1% gel at each evening meal (to maximize compliance and establish a therapeutic routine). She was also advised to use a daily cleanser and moisturizer with SPF 15. Month 1: Showed a modest decrease in inflammatory lesions. No changes to treatment. Month 2: Doxycycline was reduced to 75 mg and clindamycin 1%/benzoyl peroxide 5% gel was added after adapalene gel. Month 3: Showed continuous decrease in inflammatory lesions. Doxycycline was discontinued; other therapy remained the same as maintenance therapy. Patient Two Patient: 16-year-old female with severe comedonal acne and moderate inflammatory pustules. Treatment: She was started on doxycycline hyclate 75 mg and adapalene 0.1% gel at dinnertime. After 1 Month: Doxycycline was continued and clindamycin 1%/benzoyl peroxide 5% gel was added after adapalene gel. After 2 Months: Doxycycline was discontinued and clindamycin 1%/benzoyl peroxide 5% gel was added after adapalene gel. Patient Three Patient: 16-year-old male with severe comedonal lesions and mild primarily papular acne. Treatment: He was started on adapalene 0.1% gel, followed by clindamycin 1%/benzoyl peroxide 5% gel at dinnertime. After 1 Month: Clindamycin 1%/benzoyl peroxide 5% gel was discontinued. Adapalene monotherapy was continued as maintenance therapy. After 2 Months: Improvements were noted with adapalene 0.1% gel as continued maintenance therapy. Research Findings Successful treatment of acne requires patient compliance and maintenance therapy with topical retinoids. According to this research, “Today’s consensus is that antibiotic therapy is adjunctive, to be continued only as long as needed to control inflammatory lesions. Benzoyl peroxide, either alone or in combination with clindamycin, is useful in limiting the emergence of antibiotic resistance. Once achieved, remission is best maintained with topical retinoid therapy. It is proven that once-daily adapalene gel 0.1% gel maintains the improvement obtained after combination therapy for acne patients and may increase patient compliance among the pediatric population.” Author: James L. Campbell, Jr., M.D., M.S. Possible Positive Effect of Acne in Men A recent study in the June issue of the American Journal of Epidemiology suggests that the activity of male hormones, androgens, can cause acne in adolescence, but may help protect against coronary heart disease in adulthood. For this study, investigators examined the association between a history of acne in young adulthood and cause-specific mortality. The study included 11,232 male students who attended Glasgow University between 1948 and 1968 and participated in voluntary health checks, which included reported history of acne. For about 50% of the students, vital status has been traced and risk factors in adulthood identified. Participants with a history of acne (about 18%), were more often non-smokers while students tended to be from lower socioeconomic status. The two groups did not differ in other adolescent risk factors, including height, body mass index, blood pressure and number of siblings, or in most adult risk factors. Student who reported a history of acne had a lower risk of all-cause and coronary heart disease. The results suggest that androgen activity during adolescence may protect against coronary heart disease, but results did show a higher risk of prostate cancer mortality in this group. Acne and Milk: Is There a Link? A study published in the Journal of the American Academy of Derm-atology (JAAD) in February found a link between milk, particularly skim milk, consumption and acne. The study, based on survey responses from 47,335 women involved in an on-going study, found that women who drank two or more servings of skim milk every day were 44% more likely to have developed severe acne. Women who drank more than three daily servings of any type of milk were 22% more likely to have suffered from acne. F. William Danby, M.D., F.R.C.P.C., who was an author on the study and also spoke on this topic and the American Academy of Dermatology Annual Meeting in Chicago last month, said that it may be hormones in the milk that are causing the association between milk and acne since 75% to 90% of milk sold is from pregnant cows. According to an article Dr. Danby wrote in JAAD, it is not just the steroid hormones from the pregnant cows that may be causing acne, as milk also contains “a heavy complement of growth-enhancing hormones. Tolerability of Azelaic Acid 15% Gel in Rosacea Patients Three double-blind, randomized comparative studies of moderate papulopustular facial rosacea have shown the efficacy of azelaic acid 15% gel (Finacea). All three trials showed statistically significant reduction in inflammatory lesions and erythema with the use of azelaic acid. There was a high compliance and low discontinuation rated caused by local skin reactions. While clinical studies demonstrate that azelaic acid 15% gel is effective and safe and is, overall, tolerable, a subset of patients experience transient neurosensory symptoms. Based on a review of literature and practical experience, James Q. Del Rosso, D.O., F.A.O.C.D. presented the following findings on the clinical significance of transient neurosensory symptoms in a subset of azelaic acid 15% gel patients: The majority of cases of transient facial tingling or stinging are mild and are not associated with discontinuation of therapy. In most cases, patients experiencing neurosensory symptoms after application do not require adjustment in therapy. In about 10% of cases, temporary reduction of application to once-daily or discontinuation of therapy for a few days may be necessary. Of 60 patients reporting facial irritation after applying azelaic acid 15% gel, 80% of patients could continue treatment. In a small subset of patients (0.6%), more persistent stinging and burning may require a change in application frequency or discontinuation of product. Recommending appropriate clean-sers, moisturizers and sunscreens for rosacea patients is essential to effectively managing rosacea. Proper skin care has been shown to reduce signs and symptoms of the disease when used in combination with topical therapy. Author: James Q. Del Rosso, D.O., F.A.O.C.D. New Rosacea Clinical Scorecard The National Rosacea Society (NRS) has issued a new Rosacea Clinical Scorecard to help physicians identify and evaluate the signs and symptoms of rosacea. The scorecard is based on the standard classification and grading systems for rosacea that were developed by a consensus committee and review panel of 17 rosacea experts worldwide. The scorecard, made possible by a grant from Intendis, is intended to be used as a guide during patient examination to note the presence and severity of any of the potential signs and symptoms of rosacea. Primary and secondary features of rosacea may be rated as absent, mild, moderate or severe in separate sections on the scorecard. You can also record your global assessment of each subtype as absent, mild, moderate or severe, and also may note the patient’s global assessment. To receive free copies of the scorecard, which is available in pads of 25 sheets, contact the National Rosacea Society at (888) NO-BLUSH or by e-mailing rosaceas@aol.com. Skin & Aging - ISSN: 1096-0120 - Volume 13 - Issue 8_2005 - August 2005 - Pages: -