Treatment of palmoplantar psoriasis with infliximab: a randomized,double‐blind placebo‐controlled study

Background Palmoplantar psoriasis is a difficult to treat variant of plaque psoriasis. Objective To study the safety and efficacy of infliximab in non‐pustular palmoplantar psoriasis. Methods Patients with non‐pustular palmoplantar psoriasis affecting at least 10% of their palms and soles and with a modified palmoplantar psoriasis area and severity index (m‐PPPASI) of at least eight were recruited. Patients were randomized (1:1) to receive infliximab 5 mg/kg or placebo at weeks 0, 2 and 6. Patients initially randomized to placebo received infliximab at weeks 14, 16 and 20 whereas patients randomized to infliximab received additional infliximab infusions every 8 weeks until week 22. Results Twenty four (24) patients were randomized in this study. At week 14, 33.3% and 66.7% of patients treated with infliximab achieved m‐PPPASI 75 and m‐PPPASI 50 respectively compared to 8.3% for both m‐PPPASI 75 (P = 0.317) and m‐PPPASI 50 (P = 0.009) for patients randomized to placebo. A reduction of 50.3% in the mean surface area of palms and soles affected with psoriasis was seen at week 14 in patients randomized to infliximab as compared to an increase of 14.9% in patients randomized to placebo (P = 0.009). Conclusions This pilot study did not reach its primary endpoint of m‐PPPASI 75 at week 14. However, infliximab was observed to be more efficacious than placebo in improving PPSA and with respect to the percentage of patients reaching m‐PPPASI 50 at week 14. Larger and longer term studies are needed for severe patients to better assess the efficacy of infliximab in palmoplantar psoriasis.     

Minoxidil 2% lotion for eyebrow enhancement: A randomized,double‐blind,placebo‐controlled,spilt‐face comparative study

Topical minoxidil has been successfully used to treat androgenetic alopecia. It can also be applied to enhance eyebrows. However, there is no study comparing minoxidil lotion with placebo for eyebrow enhancement. In this trial, we determined the efficacy and safety of minoxidil 2% lotion for eyebrow enhancement compared with placebo. Forty patients were randomized for minoxidil on the eyebrow on one side of the face and placebo on the other. Efficacy was evaluated by global photographic assessment, eyebrow diameter, eyebrow count and subject's satisfaction. Side‐effects were also evaluated. Thirty‐nine patients (97.5%) completed the study. After 16 weeks, the minoxidil group achieved significantly better results in all measured outcomes compared to the placebo group. Side‐effects were minor and did not preclude patients from continuing the study. Our study suggests that minoxidil 2% lotion is a safe and effective treatment for eyebrow hypotrichosis.     

A randomized,double‐blind,placebo‐controlled study to evaluate the efficacy in AD of liquid soap containing 12% ammonium lactate + 20% urea

Atopic dermatitis (AD) is a common chronic skin disease, which mainly affects children. Xerosis is one of the most troublesome signs of the disease. The aim of this study was to evaluate the efficacy of liquid soap containing 12% ammonium lactate + 20% urea in patients with AD. In a randomized, double‐blind study, 36 patients (both male and female patients; age range 3–40 years) with mild to moderate AD were enrolled. Patients were divided randomly into two groups, in a ratio of 2 : 1 (active : placebo). The prescribed soap was used on a daily basis during a shower for 3 weeks. All patients continued all other systemic or topical medication but avoided any other soap or emollients. After 3 weeks of treatment, efficacy was assessed both by clinician and patient. There were significant improvements in scaling (P < 0.0001), skin dryness (P < 0.0001) and redness (P = 0.03) as rated by the investigator, and subjective patient assessment of itch also improved (P < 0.001) in the study group compared with the control group. The liquid soap was found to be effective in patients with AD, as use of this soap in patients with stable mild to moderate AD improved the parameters studied.     

Topical tacrolimus significantly promotes repigmentation in idiopathic guttate hypomelanosis: a double‐blind,randomized, placebo‐controlled study

Background  Idiopathic guttate hypomelanosis (IGH) is an idiopathic disorder affecting a large number of people. Effective treatments are not yet available. Objectives  To investigate the efficacy of topical 0.1% tacrolimus ointment compared with placebo in the treatment of IGH. Materials and methods  Twenty‐six patients were included in the study. Lesions on one side of the body were selected to have a treatment with 0.1% tacrolimus ointment, whereas those on the other side served as a control with placebo ointment that had the same physical appearance. Colorimeter was used to assess skin colour at baseline and at 1, 2, 3, 4 and 6 months of treatment. Results  Mean luminosity scale after adjusted for baseline from the treated side gradually decreased and reached statistical significance compared with the control group after 6 months of treatment (P = 0.019). Physicians’ improvement grading score showed that 11% of the patients demonstrated improvement of their skin lesions on the treated side after 6 months’ treatment. Conclusion  Topical 0.1% tacrolimus ointment appeared to be an effective and safe treatment for IGH. The improvements were best observed by colorimetry, yet, they were not statistically significant upon clinical assessments.     

Identification of novel step‐up regimen of intralesional triamcinolone acetonide in scalp alopecia areata based on a double‐blind randomized controlled trial

Although intralesional triamcinolone acetonide (TA) is the most commonly prescribed treatment for localized alopecia areata (AA), the literature regarding the optimal concentration for attaining better efficacy with the most acceptable side effects is scarce. To compare hair regrowth and local side effects of various concentrations of intralesional TA in scalp AA using clinical and dermoscopic parameters. A double‐blind randomized control trial with four treatment groups (10, 5, 2.5 mg/ml TA and normal saline [NS]) was conducted between March 2018 and August 2019. After recruitment, each AA patch was divided into quadrants and randomized before first injection. Injections were given and outcome parameters were analyzed every 4‐weekly till 12‐weeks. Statistical analysis was done by the R software employing generalized estimation equation. P‐value <.05 was considered significant. Out of 105‐patients (168‐AA patches), 75‐patients (121‐patches) completed the study. Hair regrowth scale of all TA concentrations was better than NS group (P < .001). Other parameters such as quadrants with poor clinical response and dermoscopic disease activity signs were also favorable in TA groups in comparison to NS. However the evidence of atrophy and telangiectasia was maximum in 10 mg/mL group. 10 mg/mL TA showed a comparatively better response at the cost of increased adverse effects. Based on the clinical benefit and adverse risk assessment from our study, it may be better to start with 2.5 mg/mL intralesional TA in limited scalp AA patients. It can be implied that the concentration of TA can be increased as a step‐up regimen based on the serial clinical and dermoscopic response.     

Effect of topical heparin and levomenol on atopic dermatitis: a randomized four‐arm,placebo‐controlled,double‐blind clinical study

Background The aim of the controlled double‐blind trial was to demonstrate the superiority of a topical combination product over its single constituents. Patients and Methods A total of 278 patients with atopic dermatitis were randomized into four groups: 79 patients were treated with a topical combination of levomenol and heparin (A), 80 patients with levomenol alone (B), 78 patients with heparin alone (C) and 41 patients with the cream base with no active substances (D). The medication was applied twice daily for 8 weeks. Efficacy criteria included the severity of pruritus (visual analogue scale, VAS) and the SCORing Atopic Dermatitis (SCORAD) index as well as the overall assessment of efficacy and tolerance by both physician and patient. Results The improvement of pruritus and SCORAD values in Group A was significantly higher compared with Groups B–D (ancova , P < 7 × 10^?8). The improvement of pruritus in Group A approximately corresponded to the cumulative effect of the two single active substances, with mean improvements of itching of ?41.3, ?13.3, ?21.3 and +0.6 mm VAS in Groups A–D, respectively (95% CI 7.1–13.5, 2.9–9.2 and 10.4–18.3 mm for the comparisons A vs. B, A vs. C and A vs. D). Conclusion The combination of levomenol and heparin proved to be significantly more efficacious in the treatment of pruritus and inflamed skin than the preparations of the single components.     

Comparative trial of a novel botulinum neurotoxin type A versus onabotulinumtoxinA in the treatment of glabellar lines: A multicenter,randomized, double‐blind,active‐controlled study

A novel botulinum neurotoxin type A (DWP450; Daewoong Pharmaceutical, Seoul, Korea) has recently been introduced for the treatment of facial wrinkles. The efficacy of this agent has previously been demonstrated in an in vivo study using an electrophysiological protocol in a rat model. To compare the efficacy and safety of DWP450 with onabotulinumtoxinA (OBoNT) for use in the treatment of glabellar lines, we performed a multicenter, double‐blind, randomized, active‐controlled trial comparing DWP450 and OBoNT (Allergan Inc., Irvine, CA, USA). A total of 268 subjects with moderate to severe glabellar lines were randomized at a 1 : 1 ratio. Each patient received treatment with 20 U of study medication. Maximum frown responder rates at week 4 were measured to analyze the primary efficacy endpoint. To evaluate secondary efficacy endpoints, response rates were measured at weeks 8, 12, and 16, at maximum frown and rest. Specifically, responder rates at both maximum frown and at rest were assessed based on clinical photography. Subject degree of satisfaction and self‐assessed rate of response were also measured. Adverse events (AEs) were documented to evaluate safety. Responder rate by physician‐rating severity at maximal contraction at week 4 was 93.89% in the DWP450 group and 88.64% in OBoNT group. As the lower limit of the 97.5% one‐sided confidence interval (– 1.53%) surpassed the – 15% threshold, we determined that DWP450 was not inferior to OBoNT. For the secondary efficacy endpoint analyses, no significant differences were observed between the two groups for any variable at any point in time. The incidences of AEs were similar for the two groups. Most of AEs were considered mild. DWP450 and OBoNT were comparable in efficacy and safety in the treatment of glabellar lines.