Single-center, assessor-blind study to evaluate the efficacy and safety of DA-5520 topical gel in patients with acne scars: A pilot study.

BACKGROUND: Unlike various topical treatment options for acne vulgaris, options for acne scars mostly involve invasive interventions. So far, only a few clinical trials have investigated the effects of topical treatment for acne scars. OBJECTIVES: We evaluated the safety and efficacy of DA-5520, a recently developed topical gel for the treatment of different types of acne scars. METHODS: A 12-week prospective, randomized, active-controlled, evaluator-blind, single-center study involving 36 participants with acne scars was performed. Participants were randomized into four different groups at a 1:1:1:1 ratio: laser resurfacing with DA-5520 application (test 1); laser resurfacing without DA-5520 application (control 1); comedone extraction with DA-5520 application (test 2); and comedone extraction without DA-5520 application (control 2). For 12 weeks, participants in the two test groups applied DA-5520 twice daily, while participants in the control groups applied moisturizers alone. Participants in the test 1 and control 1 groups received a single session of laser resurfacing at visit 1 (week 0). All participants were followed up at 1, 4, 8, and 12 weeks, and objective scar evaluation using the échelle d'évaluation clinique des cicatrices d'acné (ECCA) score was performed at each visit. RESULTS: Clinical improvement of acne scars, confirmed by the ECCA grading scale (1 for atrophic scar and 2 for hypertrophic scar), was observed after using DA-5520 when combined with laser resurfacing or individually, and no associated adverse reactions were noted. CONCLUSIONS: Preliminary results of this study revealed that DA-5520 may be a promising new formulation for treating all type of acne scars.

Effect of Oryza sativa extract on the progression of airway inflammation and remodeling in an experimental animal model of asthma.

Airway inflammation and remodeling in chronic asthma are characterized by airway eosinophilia, hyperplasia of smooth muscle and goblet cells, and subepithelial fibrosis. The present study was undertaken to evaluate the effects of DA-9201, an ethanolic extract of black rice (Oryza sativa L.), on airway inflammation and remodeling in a murine model of chronic asthma. BALB/c mice sensitized to ovalbumin (OVA) were chronically challenged with aerosolized OVA for 6 weeks. DA-9201 (30, 100, or 300 mg/kg) or dexamethasone (3 mg/kg) was orally administered during the last 4 and 2 weeks, respectively. Airway inflammation, lung pathology by histomorphometry and immunohistochemistry, IgE level and Th2 cytokines were evaluated. The OVA-treated mice showed extensive eosinophilia, chronic inflammatory responses and characteristics of airway remodeling including subepithelial fibrosis, smooth muscle hypertrophy, and goblet cell hyperplasia. As compared to the OVA-treated control group, treatment with DA-9201 resulted in significant reductions in the accumulation of eosinophils in peribronchial areas, chronic pulmonary inflammation and progression of airway remodeling. Furthermore, DA-9201 significantly reduced total serum and BALF IgE levels and Th2 cytokines. These results indicate that DA-9201 may play an important role in attenuating the progressing of airway inflammation and remodeling and suggest the potential benefits of DA-9201 in prevention or treatment of asthma.

Safety evaluation of GX-12. A new DNA vaccine for HIV infection in rodents.

Toxicity studies for the evaluation of the safety of GX-12, a naked DNA vaccine for the treatment of human immunodeficiency virus (HIV) infection, were performed in rodents. In a single dose intramuscular or intravenous toxicity study, animals were treated with up to 4000 micrograms/kg of GX-12. During the experimental period, no abnormalities in mortality, clinical finding, or body weight change were observed. For subacute toxicity study, GX-12 was administered intramuscularly once a week for thirteen weeks to rats at dosages of 0.250, 1000, or 4000 micrograms/kg. Throughout the experimental period, no dead animals, notable clinical signs, changes in body weight gain, or food and water consumptions were observed. Ophthalmic examination, urinalysis, hematology, and serum chemistry, revealed no abnormalities. In addition, there were no changes in gross findings, organ weight, and histological findings. Based on these results, the NOAEL was estimated to be excess of 4000 micrograms/kg. To assess the possible effects on the immune system, we investigated the induction of anti-DNA or anti-myosin autoantibodies in mice immunized and boosted with GX-12, and anti-GX-12 antibodies in rat serum obtained from the subacute toxicity study. GX-12 neither stimulated the production of anti-DNA or myosin autoantibodies nor induced the development of myositis or glomerulonephritis. Therefore, we concluded that GX-12 has no toxicity up to 4000 micrograms/kg in this rat model, which is 60 times higher than the expected human dose. Furthermore, given the limitations of this study, GX-12 neither initiated nor accelerated the development of systemic autoimmune responses.