Manuka oil based ECMT-154 versus vehicle control for the topical treatment of eczema: study protocol for a randomised controlled trial in community pharmacies in Aotearoa New Zealand.

BACKGROUND: Eczema is a chronic, relapsing skin condition commonly managed by emollients and topical corticosteroids. Prevalence of use and demand for effective botanical therapies for eczema is high worldwide, however, clinical evidence of benefit is limited for many currently available botanical treatment options. Robustly-designed and adequately powered randomised controlled trials (RCTs) are essential to determine evidence of clinical benefit. This protocol describes an RCT that aims to investigate whether a manuka oil based emollient cream, containing 2% ECMT-154, is a safe and effective topical treatment for moderate to severe eczema. METHODS: This multicentre, single-blind, parallel-group, randomised controlled trial aims to recruit 118 participants from community pharmacies in Aotearoa New Zealand. Participants will be randomised 1:1 to receive topical cream with 2% ECMT-154 or vehicle control, and will apply assigned treatment twice daily to affected areas for six weeks. The primary outcome is improvement in subjective symptoms, assessed by change in POEM score. Secondary outcomes include change in objective symptoms assessed by SCORAD (part B), PO-SCORAD, DLQI, and treatment acceptability assessed by TSQM II and NRS. DISCUSSION: Recruitment through community pharmacies commenced in January 2022 and follow up will be completed by mid-2023. This study aims to collect acceptability and efficacy data of manuka oil based ECMT-154 for the treatment of eczema. If efficacy is demonstrated, this topical may provide an option for a novel emollient treatment. The community-based design of the trial is anticipated to provide a generalisable result. ETHICS AND DISSEMINATION: Ethics approval was obtained from Central Health and Disability Ethics Committee (reference: 2021 EXP 11490). Findings of the study will be disseminated to study participants, published in peer-reviewed journal and presented at scientific conferences. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621001096842. Registered on August 18, 2021 ( https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382412&isReview=true ). PROTOCOL VERSION: 2.1 (Dated 18/05/2022).

Real-World Use of Ruxolitinib Cream: Safety Analysis at 1 Year.

BACKGROUND: Ruxolitinib cream is the first topical Janus kinase (JAK) inhibitor approved in the United States (US) for the treatment of mild to moderate atopic dermatitis and nonsegmental vitiligo. A postmarketing study with oral tofacitinib, approved for rheumatoid arthritis, triggered class warnings for JAK inhibitors, including risk of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. Because ruxolitinib cream is indicated for inflammatory conditions, it is subject to the same warnings as oral JAK inhibitors in the US. Here, nearly 14,000 patient-years of postmarketing safety data from the first year following market approval of ruxolitinib cream were reviewed. METHODS: The Incyte global safety database (21 September 2021-20 September 2022) and US FDA Adverse Event Reporting System (as of 30 September 2022) were queried for adverse event (AE) reports received for ruxolitinib cream. RESULTS: The search identified 294 postmarketing individual case safety reports containing 589 events, including four serious AEs and no fatal AEs. AEs (i.e., any unfavorable sign, symptom, or disease) representing >2% of all events included application site pain (n = 16), atopic dermatitis (n = 15), skin irritation (n = 15), scratch (n = 14), and condition aggravated (n = 13). The four serious AEs were skin cancer (n = 2), pericarditis, and thrombocytopenia (both n = 1), none of which had sufficient information to assess possible relatedness to ruxolitinib cream. Serious AEs associated with the class warnings for JAK inhibitors were not reported. CONCLUSIONS: Postmarketing safety data from the year following approval suggest ruxolitinib cream is generally well tolerated, without significant systemic AEs, and with a low incidence of application site reactions.

Efficacy of castor oil cream in treating infraorbital hyperpigmentation: An exploratory single-arm clinical trial.

INTRODUCTION: Infraorbital hyperpigmentation represents one of the most prevalent conditions in cosmetic dermatology. To treat this condition, many patients prefer natural remedies. This study explored the efficacy of topical castor oil cream in treating patients with infraorbital hyperpigmentation. METHODS: We conducted an exploratory single-arm clinical trial at the Shahid Faghihi Dermatology Clinic and Molecular Dermatology Research Center of Shiraz University of Medical Sciences, Shiraz, Iran, during 2021-2022. Using the convenience sampling method, we enrolled 25 patients with infraorbital hyperpigmentation. We instructed the patients to apply topical castor oil cream twice daily for 2 months. The darkness, melanin, and erythema levels were evaluated by VisioFace® 1000 D and SkinColorCatch® devices. We used a visual analog scale to assess skin laxity, wrinkles, and patient satisfaction. Data analysis was done with Stata version 14.2. RESULTS: The data of 22 patients with a mean age of 40.92 ± 7.33 years were analyzed. The VisioFace® scores decreased significantly by the end of the study [right eyes: mean difference (MD): -5.63 (95% CI: -7.12 to -4.15), p < 0.001; left eyes: MD: -5.91 (95% CI: -7.46 to -4.36), p < 0.001]. Moreover, castor oil cream significantly reduced the melanin level, wrinkles, and skin laxity in the infraorbital region (p < 0.05). CONCLUSIONS: Castor oil cream seems to be an effective alternative for treating infraorbital hyperpigmentation. Randomized clinical trials are needed to confirm our findings.

A novel, multi-active emollient for the prevention of acute radiation dermatitis in breast cancer patients: a randomized clinical trial.

PURPOSE: To investigate the efficacy of a novel, multi-active emollient in preventing and managing acute radiation dermatitis (ARD) in breast cancer patients undergoing moderate hypofractionated (HF) radiotherapy (RT) compared to standard of care. METHODSA: A monocentric, open-label, randomized clinical trial (RCT) with breast cancer patients receiving moderate HF (dose: 40.05-55.86 Gy, fractions: 15-21) was conducted between January 2022 and May 2023. The experimental group received the novel emollient, while the control group received the standard skin care. Patients applied the skin care products twice daily during the complete RT course. The primary outcome was the severity of ARD at the final RT session measured by the modified Radiation Therapy Oncology Group (RTOG) criteria. Secondary outcomes included patient symptoms, quality of life (QoL), and treatment satisfaction. RESULTS: A total of 100 patients with 50 patients per group were enrolled. In the control group, 50% of the patients developed RTOG grade 1 ARD and 48% grade 2 or higher, while in the experimental group, the severity of ARD was significantly lower with 82% grade 1 and 16% grade 2 ARD (P = .013, χ2-test). The frequency and severity of xerosis were significantly lower in the experimental compared to the control group (Ps ≤ .036, Mann Whiney U test). The impact of ARD on the QoL was low, and treatment satisfaction was high in both groups, with no significant difference. CONCLUSION: This RCT shows that the novel, multi-active emollient significantly reduced the ARD RTOG grade. Research in a more diverse patient population is warranted. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04929808 (11/06/2021).

A novel rapamycin cream formulation improves facial angiofibromas associated with tuberous sclerosis complex: a double-blind randomized placebo-controlled trial.

BACKGROUND: Facial angiofibromas (FAs) are a major feature of tuberous sclerosis complex (TSC). Topical rapamycin can successfully treat FAs. A new stabilized cream formulation that protects rapamycin from oxidation has been developed in 0.5% and 1% concentrations. OBJECTIVES: To assess the efficacy and safety of a novel, stabilized topical rapamycin cream formulation. METHODS: This multicentre double-blind randomized placebo-controlled dose-response phase II/III study with a parallel design included participants aged 6-65 years with FAs of mild or moderate severity according to the Investigator's Global Assessment (IGA) scale. Participants were randomized to one of three treatment arms: topical rapamycin 0.5%, topical rapamycin 1% or placebo. Treatment was applied once daily for 26 weeks. Safety and efficacy measures were assessed at days 14, 56, 98, 140 and 182. The primary endpoint was the percentage of participants achieving IGA scores of 'clear' or 'almost clear' after 26 weeks of treatment. Secondary measures included Facial Angiofibroma Severity Index (FASI) and participant- and clinician-reported percentage-based improvement. Safety measures included the incidence of treatment-emergent adverse events and blood rapamycin concentration changes over time. RESULTS: Participants (n = 107) were randomized to receive either rapamycin 1% (n = 33), rapamycin 0.5% (n = 36) or placebo (n = 38). All treated participants were included in the final analysis. The percentage of participants with a two-grade IGA improvement was greater in the rapamycin 0.5% treatment group (11%) and rapamycin 1% group (9%) than in the placebo group (5%). However, this was not statistically significant [rapamycin 0.5%: odds ratio (OR) 1.71, 95% confidence interval (CI) 0.36-8.18 (P = 0.50); rapamycin 1%: OR 1.68, 95% CI 0.33-8.40 (P = 0.53)]. There was a statistically significant difference in the proportion of participants treated with rapamycin cream that achieved at least a one-grade improvement in IGA [rapamycin 0.5%: 56% (OR 4.73, 95% CI 1.59-14.10; P = 0.005); rapamycin 1%: 61% (OR 5.14, 95% CI 1.70-15.57; P = 0.004); placebo: 24%]. Skin adverse reactions were more common in patients following rapamycin application (64%) vs. placebo (29%). CONCLUSIONS: Both rapamycin cream formulations (0.5% and 1%) were well tolerated, and either strength could lead to clinical benefit in the treatment of FA.

Epsolay™ (Microencapsulated Benzoyl Peroxide 5%) Cream for the Topical Treatment of Rosacea.

EpsolayTM cream is a novel topical treatment that utilizes microencapsulated benzoyl peroxide to treat moderate to severe papulopustular rosacea. It is effective at decreasing, and for some patients clearing, the papules, pustules, and telangiectasias associated with rosacea. It is well-tolerated with minimal adverse effects and has demonstrated efficacy comparable to other topical agents that are used for the condition.

Efficacy of the continuous use of a lotion with carbon dioxide on male subjects with mild acne.

OBJECTIVE: Acne vulgaris is caused by dyslipidemia, dyskeratosis and/or abnormal bacterial growth. The obstruction of skin pores due to hyperkeratosis of the infundibulum contributes to the formation of comedones. Thus, normalizing keratinization of epidermal cells in skin pores might be useful to improve acne. Recently, it has been found that the transcutaneous application of carbon dioxide (CO2 ) regulates imbalances of the desquamatory process. In this study, we evaluated the efficacy of a skin lotion containing CO2 on mild acne. METHODS: Twenty-four healthy Japanese males (20-29 years old) with mild acne attended this evaluation. The subjects were divided into 2 groups, one group used a skin lotion containing CO2 and the other group used a skin lotion without CO2 . Following facial washing, each subject topically applied the skin lotion with or without CO2 twice a day for 4 weeks. Prior to the start of the evaluation (week 0) and following 2 and 4 weeks of treatment, acne symptoms were assessed by a dermatologist and by instrumental measurements. RESULTS: Topical application of the skin lotion with CO2 for 4 weeks significantly improved acne symptoms, which was recognized by the subjects. However, treatment with the skin lotion without CO2 did not improve acne symptoms. This improvement of acne symptoms by CO2 was not accompanied by changes in sebum levels, skin surface pH, skin capacitance, or porphyrin levels. CONCLUSION: The transcutaneous application of a lotion with CO2 improves acne symptoms by normalizing keratinization without affecting skin surface conditions.

Benefits and safety of Oxymetazoline cream 1% on rosacea-associated erythema: A systematic review and analysis of clinical evidence.

BACKGROUND: Facial persistent erythema is recognized as difficult feature to treat in rosacea. Topical Oxymetazoline cream 1% has been used to treat persistent facial erythema in rosacea patients for some years. OBJECTIVE: To quantitatively synthesize the benefits and harms of Oxymetazoline cream 1% in real-world clinical management of treatment response and adverse events. METHODS: The clinical researches before June 1, 2022 published on online databases including PubMed, Web of Science, Embase and Cochrane Library were meta-analyzed. RESULTS: A total of 2298 participants were included, and the improvement rate of two-grade Clinician Erythema Assessment score (CEA) and Subject Self-Assessment for rosacea facial redness score (SSA) in Oxymetazoline group was 38% (95%CI 28-48) and 25% (95%CI 22-27), respectively, at the 4th week of the dosing. The comprehensive rate of treatment-related TEAEs in Oxymetazoline group was 7% (95%CI 5-8). The rate of stinging/burning was 15% (95%CI 10-19), pruritus was 15% (95%CI 9-22), dryness was 23% (95%CI 18-28), and scaling was 17% (95%CI 12-22) in analysis of dermal tolerability. And topical Oxymetazoline cream 1.0% presented a very low rebound rate of erythema (1%, 95%CI 0-2). CONCLUSIONS: These real-world data on Oxymetazoline cream 1% in rosacea-associated erythema may help making clinic decision and informing treatment expectations, and more clinic trials on longer-term dosing or the combination treatment with oral medication and energy-based therapy are worth exploring.

Effectiveness and safety of tofacitinib combined with narrowband ultraviolet B phototherapy for patients with refractory vitiligo in real-world clinical practice.

Vitiligo is a chronic treatment-resistant autoimmune disorder characterized by circumscribed depigmented maculae. This study was conducted to evaluate the efficacy and safety of tofacitinib combined with narrowband ultraviolet B (NB-UVB) phototherapy for refractory nonsegmental vitiligo. Fifteen patients with nonsegmental vitiligo resistant to conventional therapies were administered oral tofacitinib at 5 mg twice daily plus topical halometasone cream, tacrolimus 0.1% ointment, or pimecrolimus cream twice daily and NB-UVB three times per week for 16 weeks. The control group comprised 19 patients with nonsegmental vitiligo treated with topical drugs plus NB-UVB same as the combination group. Treatment efficacy was measured by the percentage of repigmentation of vitiligo lesions at 4th, 8th, 12th, and 16th week after beginning treatment. From 8th week, the repigmentation level was significantly higher in the combination group than in the controls. From fourth week, the response rate was significantly higher in the combination group than in the controls. Only one patient in the combination group reported mild pain in the hand and foot joints, but the pain subsided with cessation of therapy. No other severe adverse effects occurred. So, tofacitinib in combination with NB-UVB phototherapy may be an effective and safe alternative modality for refractory vitiligo.

Comparing Dermolina-Henna Cream with Mometasone Cream in Improving Radiodermatitis Among Patients with Breast Cancer: A Randomized Active-Control Double-Blind Clinical Trial.

Objectives: Radiotherapy is one of the treatments used for different types of cancer. Acute radiodermatitis is one of its most common complications. Despite the high prevalence of radiodermatitis, few studies investigated how to prevent or treat this complication. Hence, a standard treatment has not been introduced so far. We sought to evaluate the efficacy of Dermolina-Henna cream, a new polyherbal formulation, compared to Mometasone cream for alleviating acute radiodermatitis among breast cancer patients. Design: Randomized active-control double-blind clinical trial. Setting/Location: The oncology clinic of Shohaday-e Tajrish Hospital (Tehran, Iran). Subjects: Women older than 18 years with breast cancer undergoing radiotherapy. Interventions: Patients were instructed to apply a thin layer of Dermolina-Henna or Mometasone cream once daily on their lesions at least 3 h after radiotherapy for 4 weeks, and if grade I or II radiodermatitis developed, also afterward. Patients were visited weekly until end of study at after 4 weeks. Radiation Therapy Oncology Group standard questionnaires were evaluated and recorded every week as the primary outcome. Outcome measures: Primary outcome was defined as evaluating the efficacy of Dermolina-Henna cream to change the radiodermatitis grade, while the level of patients' satisfaction and the rate of adverse events recorded by patients were secondary outcomes. Results: The trends on decrease in number of lesions, erythema, radiodermatitis grade, burning sensation, pain, and itchiness were statistically significant for each treatment, separately (p < 0.001), except for radiodermatitis grade in Mometasone group (p = 0.4). Dermolina-Henna was significantly better than Mometasone in alleviating burning sensation (p < 0.001) and itchiness (p = 0.041). Approximately 3.7% of patients showed adverse events and 3.7% declared dissatisfaction in both groups. Conclusions: In summary, we showed that Dermolina-Henna cream and Mometasone cream were significantly effective in decreasing severity of radiodermatitis symptoms among patients with breast cancer. Dermolina-Henna cream was significantly superior to Mometasone cream in alleviating burning and itchiness. Clinical Trial Registration Number: IRCT20200115046144N1.

A cream containing the sap of oat plantlets and mandarin extract soothes the symptoms of rosacea and improves the quality of life of patients.

BACKGROUND: Rosacea is a chronic inflammatory disease of the facial skin that affects all skin types and occurs mostly in adults. The main clinical sign of rosacea is a characteristic and persistent form of centro-facial erythema that is prone to exacerbation and can impair quality of life (QoL). The current therapeutic approach for rosacea is to combine various treatments, use appropriate skincare products and avoid flare-up triggers. OBJECTIVE: To evaluate the use of a facial skincare product containing protein-free sap extruded from Rhealba® oat plantlets and mandarin extract in subjects with rosacea. METHODS: Three clinical studies were conducted in adult subjects with various rosacea phenotypes (erythematotelangiectatic or papulopustular) and treatment histories to assess the dermatological and ophthalmological tolerance of the study product, as well as its clinical effectiveness, after a twice-daily application on the whole face and neck for up to 4 weeks. RESULTS: Tolerance of the product was rated as good to very good by dermatologists across the three studies, which involved a total of 105 evaluable subjects. Subjects with untreated erythematotelangiectatic rosacea reported fewer functional signs and symptoms of the disease and an improved QoL. The evaluation of skin biometric parameters revealed a reduction in transepidermal water loss, indicating that the study product helped to restore skin barrier integrity after 4 weeks, and a higher skin pH, indicating that the cutaneous microbiote was respected. Most subjects (93%) who had either undergone a superficial dermatological procedure for erythematotelangiectatic rosacea or were taking oral/topical treatments for papulopustular rosacea, rated the study product as very good (8/10) and felt it further relieved their symptoms. CONCLUSION: Overall, the study product was very well tolerated and may be beneficial for subjects with rosacea as an adjunct to superficial dermatological procedures or oral/topical therapies, in line with the current recommendations for rosacea management.

Comparison of the efficacy of cysteamine 5% cream and hydroquinone 4%/ascorbic acid 3% combination cream in the treatment of epidermal melasma.

BACKGROUND: Few safe and effective treatments are available for melasma. Cysteamine, a non-melanocytotoxic molecule is a safer alternative to hydroquinone and usable for long-term use. AIM: To evaluate the effect of cysteamine 5% cream in the treatment of melasma. METHODS: Sixty-five of 80 patients completed this single-blind, randomized, controlled trial. The patients received cysteamine 5% or hydroquinone 4%/ascorbic acid 3% (HC) cream. The therapeutic response was evaluated by modified MASI (mMASI) and melanin index (SkinColorCatch) after 2 and 4 months of treatment. The effect of treatment on the quality of life was also assessed. RESULTS: The decrease in mMASI score was from 6.69 ± 2.96 to 4.47 ± 2.16 in the cysteamine group and from 6.26 ± 3.25 to 3.87 ± 2.00 in the HC group after 4 months (p values < 0.001). The melanin index decreased from 37.72 ± 10.17 to 31.47 ± 11.90 in the cysteamine group and from 36.37 ± 10.80 to 23.16 ± 8.83 in the HC group after 4 months (p-value = 0.003 and <0.001, respectively). The difference between mMASI score at baseline and month 4 was not significant between both groups (p-value > 0.05). The difference between the melanin index at baseline and month 4 was significantly more pronounced in the HC group (p-value = 0.002). Quality of life improved in both groups (p-value < 0.05), but was not significantly different between groups (p-value > 0.05). CONCLUSION: Cysteamine was confirmed to be an effective treatment for melasma, with equivalent results to HC in reducing mMASI score and improving quality of life, despite lesser melanin index reduction observed. Cysteamine and HC efficacy was confirmed in patients recalcitrant to previous treatments, by a significant reduction of mMASI and melanin index.

Assessing the frequency of adverse reactions induced by melanin-containing formulations used for the management of solar dermatitis.

BACKGROUND: Melanin from different sources is widely used by many manufacturers to produce cosmetics and sunscreens. Research data show a wide spectrum of biological activities of melanin including the protection against UV radiation and oxidants. According to the research evidence, the topical use of melanin is more effective against inflammation than the hydrocortisone. The most common side effects of topical melanin ointment are local itching, burning, and moderate hyperemia. AIM OF THE STUDY: The purpose of this work is to describe the adverse outcomes of melanin-containing formulas in patients with solar dermatitis, and to compare the frequency of adverse reactions with data from different research reports. METHODS: A Pharmacovigilance questionnaire was developed to assess potential adverse events attributable to the use of melanin ointment. We used a modified survey tool created by Jaber and coauthors. This survey of melanin application documents validated reports of adverse events manifested by objective skin changes. MEDLINE (Ovid); MEDLINE In-Process Citations & Daily Update (Ovid); PubMed (NLM) (Internet); Embase (Ovid); and Cochrane Database of Systematic Reviews were searched for the evidence on adverse reactions of topical melanin application. RESULTS: The responses documented in this survey show reliability and safety of melanin formula used for the photoprotection and treatment of solar dermatitis. Most symptoms encountered in those using melanin were consistent with exposure to excessive amount (more than 4 times per day) of the compound applied topically. Of the total 534 survey responses received, 74% reported no adverse events. A total of 140 completed adverse event reports. Melanin ointment was being administered for the indications of photo injury (burns) in 75%, photodermatitis in 18%, and solar eczematous dermatitis in 7% of patients. Data were compared with rates from other reports. CONCLUSION: We have no evidence that the chemical structure of melanin varies with currently available products, used locally or in other countries, nor that any such variability played any role in the events reported here. Further studies are required to compare the adverse events of topical melanin formulas containing melanins of different origin.

A Maximum-Use Trial of Ruxolitinib Cream in Adolescents and Adults with Atopic Dermatitis.

BACKGROUND: Ruxolitinib cream is a topical formulation of ruxolitinib, an inhibitor of Janus kinase 1 and Janus kinase 2. OBJECTIVE: We aimed to determine the safety, tolerability, and bioavailability of 1.5% ruxolitinib cream under maximum-use conditions in patients with atopic dermatitis. Efficacy was evaluated as an exploratory objective. METHODS: Eligible patients aged ≥ 12-65 years with atopic dermatitis, an Investigator's Global Assessment score ≥ 2, and ≥ 25% affected body surface area were enrolled in an open-label, maximum-use phase I study conducted in the USA and Canada. Patients applied 1.5% ruxolitinib cream twice daily to lesions identified at baseline for the first 28 days and continued use only on active lesions for an additional 28 days (extension period). Safety was assessed by frequency, duration, and severity of treatment-emergent adverse events. Plasma concentrations of ruxolitinib and pharmacokinetic parameters were assessed as secondary endpoints. RESULTS: Overall, 41 patients (median age, 17 years; 51% male) were enrolled and 37 (90.2%) entered the extension period, all of whom completed the study. Treatment-emergent adverse events were reported in 13 patients (31.7%). Treatment-related adverse events were reported in four patients (9.8%). The mean (standard deviation) steady-state plasma concentration was 104 (309) nM during the first 28 days, well below the half-maximal inhibitory concentration of Janus kinase-mediated myelosuppression in the bone marrow (281 nM), and decreased further during the extension period. Higher plasma concentrations were detected in a few patients who were treated for a very high affected body surface area. At day 56, 94.6% of patients achieved ≥ 75% improvement in the Eczema Area and Severity Index. CONCLUSIONS: Under maximum-use conditions, ruxolitinib cream was generally well tolerated, with approximately one-third of patients experiencing treatment-emergent adverse events and few treatment-related adverse events. The mean steady-state plasma concentration of ruxolitinib was well below the level expected to affect bone marrow production of blood cells, with a small number of patients exhibiting higher plasma concentrations. In addition, ruxolitinib cream showed a high level of efficacy in patients with atopic dermatitis involving ≥ 25% affected body surface area. GOV IDENTIFIER: NCT03920852.

Efficacy of probiotic-derived lotion from Lactobacillus paracasei MSMC 39-1 in mild to moderate acne vulgaris, randomized controlled trial.

BACKGROUND: Probiotics provide benefits for reducing acne. Previous studies showed an anti-inflammatory effect of Lactobacillus paracasei. However, the clinical evidence of topical probiotic lotion and acne treatment is still lacking. OBJECTIVE: To evaluate the efficacy and safety of probiotic-derived lotion compared with 2.5% benzoyl peroxide in the treatment of mild-to-moderate acne vulgaris. METHODS: Topical probiotic-derived lotion was formulated from cell-free supernatant of L. paracasei MSMC 39-1. In vitro study showed the ability of the supernatant to inhibit both antibiotic-resistance and-susceptibility strains of C. acnes and inhibit tumor necrosis factor-α. The patients with mild-to-moderate acne vulgaris on the face were randomized to receive topical probiotic-derived lotion or 2.5% benzoyl peroxide. Acne lesion counts, erythema index, and side effects were assessed after 2 and 4 weeks of treatment. RESULTS: One hundred and four acne vulgaris patients were enrolled. After four weeks of treatment, the inflammatory acne lesion counts and erythema index significantly decreased compared with the baseline in both the probiotic-derived lotion group and 2.5% benzoyl peroxide group (p < 0.001 in both groups) without statistically significant difference between the two groups (p > 0.05). However, the comedones were not affected in both groups. Four patients (7.69%) treated with probiotic-derived lotion and 14 patients (26.92%) treated with 2.5% benzoyl peroxide reported treatment-associated side effects. CONCLUSION: Probiotic-derived lotion is safe and effective for treating mild to moderate acne vulgaris, a comparable outcome with 2.5% benzoyl peroxide. It could be an alternative treatment of acne with more minor side effects.

Inhaled Dry Powder Mannitol Treatment in Pediatric Patients with Cystic Fibrosis: Evaluation of Clinical Data in a Real-World Setting.

Background: Cystic fibrosis (CF) is a genetic disorder, in which defective clearance of airway secretions leads to progressive lung function loss. Inhaled mannitol is used to increase sputum and mucociliary clearance. There are little data from real-world studies on the effectiveness of mannitol in children. Our objective was to evaluate the spirometry and clinical results of mannitol in pediatric patients. Methods: We retrospectively reviewed the records of 30 children and adolescents with CF receiving inhaled mannitol who were already on recombinant human deoxyribonuclease (rhDNase) treatment. The change in forced expiratory volume in 1 second (FEV1) from baseline at 2-4 months was the primary outcome. Secondary measures were other spirometry results, body mass index (BMI), hospital admissions, sputum characteristics, and positive bacterial colonization. Results: Compared to baseline, we found significant improvement in percent predicted FEV1 at 2-4 months of treatment; 84.50 (58.00-99.00) vs. 96.00 (66.00-106.00) (P = 0.0007). The absolute change in FEV1 was +11.5% at 2-4 months, +6.5% at 5-7 months, and +4% at 8-12 months. Also, significant improvements in other spirometry results were observed. Adolescents had significantly lower FEV1 results, but the improvement in their lung function was sustained for a more extended period than children. Mannitol provided easier sputum removal, increased sputum volume, significant decline in hospitalizations, and significantly fewer patients with positive sputum cultures. A significant increase in BMI at 8-12 months was observed. Cough was the most frequent adverse effect. Conclusion: In a real-world setting, our results demonstrated that adding mannitol to rhDNase therapy is tolerable in pediatric patients with CF and may provide improved spirometry and clinical outcomes. In addition, our results showed that mannitol provided recovery in overall lung function at 2-4 months, which was sustained up to 12 months together with improved BMI, easier sputum removal, and a decline in bacterial colonization and hospital admissions. However, cough was the most frequent side effect.

Effects of an emollient application on newborn skin from birth for prevention of atopic dermatitis: a randomized controlled study in Thai neonates.

BACKGROUND: Enhancing the skin barrier in high-risk neonates by daily use of emollients during infancy might prevent atopic dermatitis (AD); however, there have been no studies on this topic in a country with a tropical climate. Climate may affect the results of the use of emollients in neonates for AD prevention and possible adverse cutaneous eruptions. OBJECTIVES: To test the hypothesis that emollients used during infancy can prevent AD in high-risk neonates in a country with a tropical climate and to evaluate other possible adverse cutaneous eruptions in this population. METHODS: This was a randomized controlled study in a tertiary care hospital with a 6 months' duration. Eligible neonates were randomly assigned to receive either emollient and skincare advice (emollient group) or skincare advice only (control group). The intervention was started within 3 weeks of birth. RESULTS: The emollient group showed a significant reduction in the cumulative incidence of AD at 6 months (relative risk, 0.39; 95% CI 0.24-0.64; P < 0.001). The emollient group started to develop AD later and had a lower severity of AD than the control group (P < 0.001). Compared to moderate adherence, low adherence to emollient application was associated with a lower number of patients with AD (P = 0.008). Potentially emollient-related cutaneous eruptions, such as miliaria, and suspected cutaneous infections, such as impetigo, were more frequent in the emollient group. Exposure to passive smoking showed a significant difference in the development of AD compared to non-smoking exposure, both during pregnancy and after the child's birth (P < 0.001). CONCLUSIONS: This study suggests that, in a tropical climate, emollient applied to the skin of at-risk neonates on an 'as needed' basis (depending on environmental factors, level of skin dryness), rather than on a 'daily basis', can provide a substantial benefit for AD prevention.