An evaluation of dapsone gel 5% in the treatment of acne vulgaris.
Expert Opin Pharmacother. 2009 Jun; 10(9): 1515-21Pickert A, Raimer SBACKGROUND: Oral dapsone has been available for over 60 years. Its first clinical use was discovered in 1945, when it was found to be efficacious in inhibiting the progression of leprosy. The combined antibacterial and anti-inflammatory pharmacologic activities of dapsone have made it a widely investigated drug, particularly for use in refractory and unusual dermatologic conditions. However, the possibility of significant hematological side effects, even at low doses, has limited its use. Currently, oral dapsone has FDA approval for the treatment of leprosy and dermatitis herpetiformis. The potential of oral dapsone to treat acne vulgaris is well established, but the risks of serious side effects have made it an undesirable drug for use in the relatively healthy acne population. Recently, a topical formulation of dapsone (Aczone, Allergan, Inc., Irvine, CA, USA) has been approved by the FDA for the treatment of acne vulgaris. OBJECTIVE/METHODS: The aims of this study were to review the published literature on dapsone pharmacology and pharmacokinetics, and to evaluate the gel's efficacy and safety in treating acne vulgaris, and finally to provide personal insight into its future as a topical agent for acne vulgaris. RESULTS/CONCLUSIONS: Clinical studies indicate dapsone gel 5% is effective in treating mild to moderately severe acne. It is well tolerated, with pharmacokinetic evidence indicating topical dosing in comparison to oral administration significantly reduces systemic concentrations of the drug, and therefore risk of serious side effects. Data suggests that dapsone gel 5% has the potential to become an established topical drug for the treatment of acne vulgaris. However, studies comparing the clinical effectiveness of the dapsone gel 5% to other available topical antiacne drugs are needed as are studies accessing its usefulness and safety when combined with other acne pharmaceuticals.
Efficacy of an oral contraceptive containing EE 0.03 mg and CMA 2 mg (Belara) in moderate acne resolution: a randomized, double-blind, placebo-controlled Phase III trial.
Contraception. 2009 Jul; 80(1): 25-33Plewig G, Cunliffe WJ, Binder N, Höschen KBACKGROUND: The study was conducted to assess the effects of the monophasic combined oral contraceptive containing ethinyl estradiol (EE) 0.03 mg and chlormadinone acetate (CMA) 2 mg (EE/CMA) on papulopustular acne of the face, décolleté (low neck) and back; on moderate comedonal acne of the face; and on seborrhea, alopecia and hirsutism. STUDY DESIGN: Three hundred seventy-seven women were randomized (2:1) to receive EE/CMA (n=251) or placebo (n=126) for six medication cycles. Due to the placebo-controlled, double-blind design of the trial, condoms were supplied for contraception. The primary efficacy end point was defined as a reduction of at least 50% in the number of papules and/or pustules of the face from admission to Medication Cycle 6. RESULTS: In total, 64.1% (161/251) of subjects treated with EE/CMA responded compared with 43.7% (55/126) of those taking placebo (p=.0001). The median reduction in papules/pustules on the face at Cycle 6 compared with admission was 63.6% (EE/CMA) compared with 45.3% (placebo group). For comedonal lesions of the face, the reduction in lesion numbers was 54.8% (EE/CMA) compared with 32.4% (placebo). Moderate papulopustular acne of the décolleté decreased by 92.9% (EE/CMA) vs. 50% (placebo group) and of the back by 86.0% and 58.3%, respectively. For these skin conditions, the p values for the relative difference between groups vs. baseline were
Isotretinoin and intestinal damage.
Prescrire Int. 2008 Aug; 17(96): 154-6(1) Isotretinoin, a vitamin A derivative, is marketed as an oral treatment for refractory severe acne. It is known to carry a risk of severe birth defects. The skin tends to become dry and fragile during isotretinoin treatment; (2) Some adverse effects of isotretinoin are caused by damage to the intestinal mucosae. These effects include bloody and mucousy diarrhoea, colitis, ileitis (sometimes severe and necessitating surgery), and aggravation of inflammatory bowel disease such as Crohn's disease; (3) Isotretinoin can affect all mucous membranes, causing multiple disorders of varying severity, affecting: the eyes (conjunctivitis); ear, nose and throat (epistaxis); respiratory tract; gastrointestinal tract (colitis); and urinary tract; (4) Patients must be informed of the risk of mucosal damage and especially of intestinal disorders associated with isotretinoin therapy. Isotretinoin should be borne in mind as a possible cause when a young patient presents with gastrointestinal disorders, and its withdrawal should be envisaged. Isotretinoin is an additional risk factor in patients with a personal or familial history of inflammatory bowel disease.
