Efficacy and safety of a novel topical minocycline foam for the treatment of moderate to severe acne vulgaris: A phase 3 study.

BACKGROUND: FMX101 4% topical minocycline foam has been shown to be an effective and safe treatment for acne vulgaris (AV). OBJECTIVE: To further evaluate the efficacy and safety of FMX101 4% in treating moderate to severe acne vulgaris. METHODS: A 12-week, multicenter, randomized (1:1), double-blind, vehicle-controlled study was conducted. Coprimary end points were the absolute change in inflammatory lesion count from baseline and the rate of treatment success (Investigator's Global Assessment score of 0 or 1 with a ≥2-grade improvement). RESULTS: There were 1488 participants in the intent-to-treat population. The FMX101 4% group had significantly greater reductions in the number of inflammatory lesions from baseline (P < .0001) and a greater rate of treatment success based on Investigator's Global Assessment (P < .0001) versus the foam vehicle group at week 12. FMX101 4% was generally safe and well tolerated. LIMITATIONS: The efficacy and safety of FMX101 4% were not characterized in participants with mild AV. CONCLUSION: FMX101 4% topical minocycline foam was effective and safe for the treatment of moderate to severe AV.

Cyanoacrylates for skin closure.

Cyanoacrylates (CAs) were not widely adopted for medical use until recently because of lingering concerns regarding the initial tissue toxicities of the short-chain CAs. The medium-chain CAs, primarily butyl-cyanoacrylate, have been widely used in Europe and Canada for several decades and have gone a long way in dispelling any lingering concerns about tissue toxicity. The newer, longer chain CA, octyl-2-cyanoacrylate (2-OCA), now has been approved for multiple uses in the United States and has achieved widespread acceptance by the medical and lay communities. The current authors believe that this is probably only the beginning of the use of 2-OCA and other CAs in cutaneous medicine. This article discusses the use of CAs in their original cutaneous use as glues for the repair of lacerations and incisions and in their more recent use as dressings for the treatment of abrasions and wounds.

Use of infliximab, an anti-tumor necrosis alpha antibody, for inflammatory dermatoses.

BACKGROUND: Infliximab is a monoclonal antibody against tumor necrosis factor alpha currently approved by the U.S. FDA for the treatment of Crohn's disease and rheumatoid arthritis. Recently, a controlled trial reported its effectiveness for psoriasis. OBJECTIVE: The object of our study was to evaluate the efficacy and safety of infliximab for inflammatory or autoimmune cutaneous disorders. METHODS: A retrospective chart review was performed for patients who received infliximab at the University of Miami, Cedars Medical Center. RESULTS: Patients with various disease, including panniculitis, pityriasis rubra pilaris, eosinophilic fasciitis, discoid lupus erythematosus, and necrobiosis lipoidica diabeticorum, received infliximab infusion at a dose of 5 mg/kg. All patients had refractory disease or adverse effects to previous therapy, which included cyclosporine, systemic steroids, azathioprin, clofazimine, mycophenolate mofetil, acitretin, UVB, and thalidomide. Six out of the seven patients improved after treatment. CONCLUSIONS: Infliximab was well tolerated in most patients and the majority benefited from the use of infliximab.

Evaluation of superficial basal cell carcinomas after treatment with imiquimod 5% cream or vehicle for apoptosis and lymphocyte phenotyping.

OBJECTIVE: To characterize the immune response and the apoptotic pathways that result in regression of imiquimod-treated basal cell carcinomas (BCCs). METHODS: The trial was conducted as an open-label, matched controlled, nonrandomized study. Twelve patients were assigned as either active-treatment patients or matched control subjects. After treatment, lesions were excised and stained for CD20, CD3, CD4, CD56, bcl-2, bax, caspase-3, and p53. Additionally, a DNA fragmentation assay was performed using the terminal deoxynucleotidyltransferase-mediated dUTP nick-end-labeling method. RESULTS: All vehicle-treated BCCs (six of six) had residual tumor compared with four of six imiquimod-treated BCCs. A dense mononuclear infiltrate surrounded all of the imiquimod-treated tumors and only one of six vehicle-treated BCCs. Staining for CD20, CD3, and CD4 revealed that the infiltrate consisted primarily of T-helper lymphocytes; however, a significant portion of the cells stained positively for CD56, indicating the presence of natural killer cells. Imiquimod-treated BCCs stained more strongly for caspase-3 and to a lesser degree p53 as compared with vehicle-treated BCCs. No differences were seen in either bax or bcl-2 staining. Minimal apoptosis was seen with the terminal deoxynucleotidyltransferase-mediated dUTP nick-end-labeling assay in either group. CONCLUSION: This study provides evidence that imiquimod's antitumorigenic effects are mediated via up regulation of local interferon-alpha levels and supports previous work, suggesting that increased natural killer cell activity may be an important factors explaining both spontaneous regression and IFN-alpha induced regression of BCC.

A liquid adhesive bandage for the treatment of minor cuts and abrasions.

BACKGROUND: Octyl-2-cyanoacrylate is U.S. Food and Drug Administration (FDA) approved for the closure of incisions and lacerations. In animal studies, a more flexible formulation of octyl-2-cyanoacrylate suitable for cuts and abrasions produced faster healing of partial thickness wounds than traditional bandages. OBJECTIVE: To evaluate the effectiveness of a more flexible octyl-2-cyanoacrylate liquid adhesive bandage for the treatment of minor cuts and abrasions. METHODS: One hundred sixty-two volunteers with recent minor cuts or abrasions were recruited and randomized to treatment with either liquid adhesive bandage (LAB) or a control device (Band-Aid brand adhesive bandage, sheer, 2.5 cm). The primary efficacy criterion was complete healing at day 12. Secondary efficacy criteria were the ability of patients to properly apply LAB, and the ability of LAB to stop bleeding, to reduce pain, and to remain on the wound. RESULTS: At day 12 there was no statistical difference between the number of completely healed wounds in the LAB and the bandage-treated patients (P =.493). The ability of patients, as rated by investigators, to effectively apply the LAB device and the bandage was not significantly different (P =.165). Only the LAB provided significant hemostasis (P =.0001) and pain relief (P =.002). CONCLUSION: In this randomized, controlled trial, the LAB was as effective as the control at promoting healing as measured by complete healing at day 12. The LAB was easy to use and gave rapid control of bleeding and pain, forming a film that stayed on wounds well.