Comparison of Efficacy and Safety Between Propranolol and Steroid for Infantile Hemangioma: A Randomized Clinical Trial.

Importance: There are limited data from randomized clinical trials comparing propranolol and steroid medication for treatment of infantile hemangioma (IH). Objective: To determine the efficacy and safety of propranolol compared with steroid as a first-line treatment for IH. Design, Setting, and Participants: This randomized clinical noninferiority trial tested the efficacy and safety of propranolol vs steroid treatment for IH at a single academic hospital. All participants were diagnosed with IH between June 2013 and October 2014, had normal heart function, and had not been previously treated for IH. Interventions: The participants were randomly assigned to either the propranolol group or the steroid group. In the propranolol group, the patients were admitted, observed for adverse effects for 3 days after treatment initiation, and then released and treated as outpatients for 16 weeks (2 mg/kg/d). In the steroid group, the patients were seen as outpatients from the beginning and were also treated for 16 weeks (2 mg/kg/d). Main Outcomes and Measures: The primary efficacy variable was the response to treatment at 16 weeks, which was evaluated by the hemangioma volume using magnetic resonance imaging before and at 16 weeks after treatment initiation. While comparing the effect of medication between the groups, we monitored the adverse effects of both drugs. Results: A total of 34 patients (15 boys, 19 girls; mean age, 3.3 months; range, 0.3-8.2 months) were randomized to receive either propranolol or steroid treatment (17 in each treatment group). Guardians for 2 patients in the steroid group withdrew their consent, and 1 patient in the propranolol group did not complete the efficacy test. The intention-to-treat analysis, applying multiple imputations, found the treatment response rate in the propranolol group to be 95.65%, and that of the steroid group was 91.94%. Because the difference in response rate between the groups was 3.71%, propranolol was considered noninferior. We found that there was no difference between the groups in safety outcomes. Conclusions and Relevance: Our trial demonstrated that propranolol was not inferior to steroid with respect to therapeutic effects in IH. Trial Registration: clinicaltrials.gov Identifier: NCT01908972.

Topical valproic acid increases the hair count in male patients with androgenetic alopecia: a randomized, comparative, clinical feasibility study using phototrichogram analysis.

Valproic acid (VPA), a widely used anticonvulsant, inhibits glycogen synthase kinase 3ß and activates the Wnt/ß-catenin pathway, which is associated with hair growth cycle and anagen induction. To assess the efficacy of topical VPA for treating androgenetic alopecia (AGA), we performed a randomized, double-blind, placebo-controlled clinical trial. Male patients with moderate AGA underwent treatment with either VPA (sodium valproate, 8.3%) or placebo spray for 24 weeks. The primary end-point for efficacy was the change in hair count during treatment, which was assessed by phototrichogram analysis. Of the 40 patients enrolled in the study, 27 (n = 15, VPA group; n = 12, placebo group) completed the entire protocol with good compliance. No statistical differences in age, hair loss duration and total hair count at baseline were found between the groups. The mean change in total hair count was significantly higher in the VPA group than in the placebo group (P = 0.047). Both groups experienced mostly mild and self-limited adverse events, but their differences in prevalence rates were similar between the two groups (P = 0.72). A subject treated with topical VPA developed ventricular tachycardia, but it did not seem to be related to the VPA spray. Topical VPA increased the total hair counts of our patients; therefore, it is a potential treatment option for AGA.

Long-pulsed Nd:YAG laser on periorbital wrinkles in Asian patients: randomized split face study.

BACKGROUND AND OBJECTIVE: This study evaluated clinical usefulness of long-pulsed Nd:YAG laser (LPNY) for periorbital wrinkles in Asian patients. METHODS: Twenty seven Korean patients were treated with several passes of LPNY (5 mm spot size, fluence: 54.7-61.8 J/cm(2), pulse duration: 56.5 microseconds). Three treatment sessions were conducted every 2 weeks on the half side of face that was randomly assigned. Outcome assessments included photography, global evaluation by two blinded independent dermatologists (using Fitzpatrick Wrinkle Classification System), and objective measurements of skin elasticity. Adverse events were documented. Patients reported their degree of satisfaction on a 6-point {0-5) visual analog scale (VAS). RESULTS: All patients showed modest improvement. The mean wrinkle score on the treated side decreased by 34.9% (p < 0.05), while it did not change significantly on the control site. Skin elasticity (R2) increased significantly on the treated site. The average VAS score was 2.85 at 2 months but it dropped down to 1.05 at 6 months follow-up. No adverse effects were noted except 2 weeks lasting erythema in one patient. CONCLUSION: LPNY may be considered as a safe treatment option for periorbital wrinkles in Asian patients. However, three treatment sessions are not enough for maintaining optimal clinical outcome.

Effect of propranolol on the treatment of infantile hemangiomas: a single tertiary center 3-year experience.

BACKGROUND: Propranolol has recently become a successful first-line therapy in the treatment of infantile hemangiomas (IHs). OBJECTIVE: To evaluate and analyze the authors' experience of propranolol treatment for IHs. METHODS: A retrospective, observational study was conducted. Medical records were reviewed. To evaluate the outcome of treatment, serial digital photographs using a visual analog scale were compared. RESULTS: Eighty-three patients with a mean age of 5.35 ± 5.15 months had 107 IHs treated by oral propranolol at a dose of 2 mg/kg/day. The mean percent improvement in the size and extent were 14.3% at 1 week, 45.4% at 9 weeks, 69.1% at 21 weeks and 83.8% at 53 weeks after beginning propranolol treatment. Eight patients (9.6%) reported mild side effects including hypoglycemia (n = 4), hypotension without associated symptoms (n = 2), bradycardia (n = 1) and somnolence (n = 1). Regrowth of IH after cessation of propranolol was reported in 18 patients (21.7%). There is no significant predictor of response to treatment and regrowth after cessation of treatment. CONCLUSIONS: Propranolol was highly effective and safe in the treatment of IHs. Effect of propranolol treatment started rapidly within 1 week, and was very promising regardless of patients' and lesions' characteristics. Based on the authors' observation, they suggest that treatment should be continued several months after the proliferative phase is considered to stop clinically.

Differentiation of benign pigmented skin lesions with the aid of computer image analysis: a novel approach.

BACKGROUND: The differential diagnosis of common pigmented skin lesions is important in cosmetic dermatology. The computer aided image analysis would be a potent ancillary diagnostic tool when patients are hesitant to undergo a skin biopsy. OBJECTIVE: We investigated the numerical parameters discriminating each pigmented skin lesion from another with statistical significance. METHODS: For each of the five magnified digital images containing clinically diagnosed nevus, lentigo and seborrheic keratosis, a total of 23 parameters describing the morphological, color, texture and topological features were calculated with the aid of a self-developed image analysis software. A novel concept of concentricity was proposed, which represents how closely the color segmentation resembles a concentric circle. RESULTS: Morphologically, seborrheic keratosis was bigger and spikier than nevus and lentigo. The color histogram revealed that nevus was the darkest and had the widest variation in tone. In the aspect of texture, the surface of the nevus showed the highest contrast and correlation. Finally, the color segmented pattern of the nevus and lentigo was far more concentric than that of seborrheic keratosis. CONCLUSION: We found that the subtle distinctions between nevus, lentigo and seborrheic keratosis, which are likely to be unrecognized by ocular inspection, are well emphasized and detected with the aid of software.

Cyclosporin treatment of atopic dermatitis: is it really associated with infectious diseases?

BACKGROUND: Patients with severe atopic dermatitis (AD) can benefit from cyclosporin (CSA) treatment. Some studies reported that CSA can cause infectious diseases as side effects. OBJECTIVE: To investigate the possible association of CSA treatment in AD patients with infectious diseases. METHODS: We performed a case-controled study on 202 patients with AD, 101 of whom were taking CSA and 101 who were not. Retrospective medical record review was held, and the incidence of infectious disease in both groups was compared. RESULTS: The total number of infectious diseases in the CSA group was slightly lower than in control group but that was not statistically significant. Similarly, the incidence density was almost the same in the two groups. In both groups, eczema herpeticum was the most common infection. CONCLUSION: Our results suggest that CSA therapy in AD does not increase the incidence of infectious disease.