RESUMEN
OBJECTIVE: To investigate the efficacy and safety of increasing doses of cathine (nor-pseudoephedrine) as a weight-lowering agent in patients with obesity. METHODS: Overweight and obese patients (n = 241, mean BMI 34.6 ± 3.4 kg/m²) were randomly allocated to one of three doses of cathine (16 mg, 32 mg, 53.3 mg) or placebo in addition to a multimodal lifestyle intervention program in a multicenter, double-blind, controlled, dose-finding study for 24 weeks. Primary outcome was weight loss. RESULTS: Treatment with the 3 doses of cathine resulted in a significantly greater weight loss compared to placebo over 24 weeks: 6.5 ± 4.2 kg for 16 mg cathine, 6.2 ± 4.7 kg for 32 mg cathine, and 9.1 ± 5.4 kg for 53.3 mg cathine versus 2.4 ± 4.4 kg for placebo (each p < 0.01, ANCOVA). The percentage of patients losing > 5% / >10% of initial body weight was significantly greater for all doses of cathine than for placebo (each p < 0.01, chi-square test). Heart rate increased dose-dependently (by 1.2 bpm under 16 mg, 5.8 bpm under 32 mg, and 6.2 bpm under 53.3 mg cathine), but no suspected unexpected serious adverse reactions were noted. The overall dropout rate was 24.9%, with the highest rate in the placebo group (42.3%). CONCLUSION: Cathine appears to be an effective weight-lowering agent for adjunct treatment of obesity, but additional clinical studies on its efficacy and safety are required.
Asunto(s)
Fármacos Antiobesidad , Obesidad/tratamiento farmacológico , Fenilpropanolamina/efectos adversos , Fenilpropanolamina/uso terapéutico , Adulto , Fármacos Antiobesidad/efectos adversos , Fármacos Antiobesidad/uso terapéutico , Índice de Masa Corporal , Peso Corporal , Método Doble Ciego , Femenino , Frecuencia Cardíaca/efectos de los fármacos , Humanos , Masculino , Persona de Mediana Edad , Sobrepeso/tratamiento farmacológico , Fenilpropanolamina/administración & dosificación , Placebos , Pérdida de Peso/efectos de los fármacosRESUMEN
BACKGROUND: Cleansing products for acne should remove excessive sebum, reduce acne-related bacteria and improve inflammation. AIMS: The aim of the study was to investigate a topical cleansing product containing glycolic acid with pH 4 in mild acne vulgaris. METHODS: Sixty patients were recruited for this open uncontrolled clinical trial. The tested product was exclusively applied twice a day for 6 weeks. The efficacy was judged by a dermatologist according to the Leeds score after 3 and 6 weeks. In addition, efficacy and tolerability were judged subjectively by physician and patients. RESULTS: Mild acne improved significantly after 6 weeks (baseline: 0.699 vs. day 42: 0.602; P < 0.001). Efficacy and tolerability were judged better by physician as compared with patients' assessment. CONCLUSION: In this clinical trial, a topical cleansing product containing glycolic acid with pH 4 improved mild acne significantly following twice-daily application for 6 weeks as monotherapy.
Asunto(s)
Acné Vulgar/tratamiento farmacológico , Detergentes/administración & dosificación , Glicolatos/administración & dosificación , Adolescente , Adulto , Detergentes/efectos adversos , Detergentes/química , Femenino , Glicolatos/efectos adversos , Glicolatos/química , Humanos , Concentración de Iones de Hidrógeno , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Factores de Tiempo , Adulto JovenRESUMEN
BACKGROUND: Acne is characterized by hyperseborrhea, follicular hyperkeratosis, and growth of propionibacteria. Alpha hydroxy acids depending on the pH of the finished product exhibit comedolytic as well as antimicrobial properties. OBJECTIVES: The aim of this study was to investigate an oil-in-water emulsion-containing 10% glycolic acid (pH 4; Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany) as monotherapy in mild acne regarding clinical efficacy and tolerability for 90 days. PATIENTS AND METHODS: Patients (n = 120; 73 f, 47 m) suffering from mild acne (Leeds score 0.25-1) aged ≥12 (mean 21 ± 5.8) were included in this double-blind, placebo-controlled, randomized, monocentric trial. The cream was applied once daily in the evening. No additional products were used. Cleansing was standardized by supplying the same product to all patients. RESULTS: The number of patients (n = 115) in the per-protocol and intention-to-treat analysis was the same. Acne improved significantly in the verum group up to day 90. Already at day 45, there was a statistical significant (5% level) difference against placebo. The subjective evaluation of the verum by physicians and patients regarding clinical efficacy and tolerability was favorable. Regarding reported adverse effects, there was no statistically significant difference (5% level) between verum and placebo. CONCLUSIONS: The 10% glycolic acid containing oil-in-water emulsion improved mild acne applied as monotherapy in this study significantly, already after 45 days of treatment. Regarding tolerability, there was no objective or subjective difference between the 10% glycolic acid containing oil-in-water emulsion and the corresponding placebo.