Impact of active pharmaceutical ingredient variables and oleaginous base on the in vitro drug release from ophthalmic ointments: An investigation using dexamethasone as a model drug.

The present study systematically investigates the impact of active pharmaceutical ingredient (API) variables and oleaginous base characteristics on the in vitro release (IVR) performance of ophthalmic ointments, utilizing dexamethasone as a model drug. The interplay between selected attributes (i.e., particle size distribution, crystallinity, and polymorphic form for API, and rheological factors for compendial-grade white petrolatum) and IVR performance was investigated. APIs from different vendors exhibited variations in crystallinity and polymorphism. Ointments containing amorphous dexamethasone presented higher release amounts/rates compared to crystalline counterparts, emphasizing the role of physical state in release kinetics. Variations in particle size of this lipophilic API (5.4 - 21.2 µm) did not appear to impact IVR performance significantly. In contrast, white petrolatum's rheological attributes, which varied substantially within USP-grade petrolatum, were found to critically affect the drug release rate and extent of the ointment. The study's comprehensive analysis establishes a coherent connection between the quality attributes of both API and petrolatum and IVR, delineating their intricate interdependent effects on ophthalmic ointment performance. These findings provide reference to formulation design, quality control, and regulatory considerations within the pharmaceutical industry, fostering a robust foundational understanding of commonly overlooked quality attributes in ophthalmic ointments.

Case report of recurrent epistaxis caused by a live leech in the nasal cavity.

RATIONALE: Epistaxis is one of the common emergencies in otolaryngology. There are many causes of epistaxis, but reports of epistaxis due to nasal foreign bodies like leeches are rare. PATIENT CONCERNS: A 55-year-old male presented with "repeated epistaxis for over 20 days." Nasal endoscopy revealed a live leech in the olfactory area of the left nostril. DIAGNOSES: The patient was diagnosed with epistaxis caused by a live leech in the nasal cavity. INTERVENTIONS: Under nasal endoscopy, the leech was grasped with a vascular clamp and removed from the nasal cavity. The leech measured 8 cm in length. Hemostasis was achieved using a gelatin sponge at the wound site, and the nasal cavity was packed with Vaseline gauze. OUTCOMES: The live leech was removed via nasal endoscopy. Two days later, the Vaseline gauze packing was removed, and the patient experienced no further nasal bleeding. CONCLUSION: Live leeches in the nasal cavity can cause epistaxis. Nasal endoscopic removal of the live leech is an effective treatment. LESSON: There are many causes of epistaxis, which are nonspecific and prone to missed or incorrect diagnosis. In patients with a history of fieldwork or direct contact with leeches who present with recurrent nasal bleeding, the possibility of epistaxis caused by a live leech should be considered, and timely and effective treatment should be provided.

Sustainable Alternatives to Petroleum-Derived Excipients in Pharmaceutical Oil-in-Water Creams.

Recently, vast efforts towards sustainability have been made in the pharmaceutical industry. In conventional oil-in-water (O/W) cream formulations, various petroleum-based excipients, namely mineral oil and petrolatum, are commonly used. Natural or synthetic excipients, derived from vegetable sources, were explored as alternatives to petroleum-based excipients in prototype topical creams, with 1% (w/w) lidocaine. A conventional cream comprised of petroleum-derived excipients was compared to creams containing sustainable excipients in terms of key quality and performance attributes, physicochemical properties, and formulation performance. The petrolatum-based control formulation had the highest viscosity of 248.0 Pa·s, a melting point of 42.7°C, a low separation index at 25°C of 0.031, and an IVRT flux of 52.9 µg/cm2/h. Formulation SUS-4 was the least viscous formulation at 86.9 Pa·s, had the lowest melting point of 33.6°C, the highest separation index of 0.120, and the highest IVRT flux of 139.4 µg/cm2/h. Alternatively, SUS-5 had a higher viscosity of 131.3 Pa·s, a melting point of 43.6°C, a low separation index of 0.046, and the lowest IVRT flux of 25.2 µg/cm2/h. The cumulative drug permeation after 12 h from SUS-4, SUS-5, and the control were 126.2 µg/cm2, 113.8 µg/cm2, and 108.1 µg/cm2, respectively. The composition of the oil-in-water creams had influence on physicochemical properties and drug release; however, skin permeation was not impacted. Sustainable natural or synthetic excipients in topical cream formulations were found to be suitable alternatives to petroleum-based excipients with comparable key quality attributes and performance attributes and should be considered during formulation development.

Effect of stearyl alcohol on imiquimod-induced psoriasis-like skin inflammation in mice.

Psoriasis is a chronic inflammatory skin disease. Topical medicines are the preferred treatment for mild to moderate psoriasis, but the effect of excipients used in semi-solid preparations on psoriasis-like skin inflammation is not fully understood. In the present study, we investigated the effect of stearyl alcohol, a commonly used excipient, on imiquimod (IMQ)-induced psoriasis-like skin inflammation in mice. Psoriasis-like skin inflammation was induced by topical IMQ treatment on the back of mice. Skin lesion severity was evaluated by using psoriasis area and severity index (PASI) scores. The skin sections were stained by haematoxylin-eosin and immunohistochemistry. Stearyl alcohol (20% in vaseline) treatment significantly reduced the IMQ-induced increase of PASI scores and epidermal thickness in mice. IMQ treatment increased the number of Ki67- and proliferating cell nuclear antigen (PCNA)-positive cells in the skin, and the increases were inhibited by stearyl alcohol (20% in vaseline) treatment. Stearyl alcohol treatment (1%, 5%, 10% in vaseline) dose-dependently ameliorated IMQ-induced increase of PASI scores and epidermal thickness in mice. Hexadecanol (20% in vaseline), stearic acid (20% in vaseline) and vaseline treatment had no significant effect on IMQ-induced psoriasis-like skin inflammation in mice. In conclusion, stearyl alcohol has the effect of improving IMQ-induced psoriasis-like skin inflammation in mice.

A Comparative Observation on Wound Healing After Surgery for Necrotizing Fasciitis: Kangfuxin Liquid Gauze versus Vaseline Gauze.

Objective: To evaluate the effectiveness of Kangfuxin Liquid (a traditional Chinese medicine) gauze and Vaseline gauze in wound healing after necrotizing fasciitis surgery. Method: The study was conducted at The First Affiliated Hospital of Baotou Medical College between February 2020 and February 2022. A total of 54 patients diagnosed with necrotizing fasciitis were randomly assigned to the Vaseline gauze group as the control group, and the Kangfuxin Liquid gauze group as the experimental group. Various aspects of treatment efficacy, wound healing conditions, healing indicators, pain scores, inflammation markers, and adverse reactions were compared between the two groups. Results: The total effective rate in the experimental group (100.00%) was significantly higher than that in the control group (77.78%), with a statistically significant difference The experimental group showed lower scores for secretion, granulation tissue morphology, redness, and swelling compared to the control group, with statistical significance. Additionally, the experimental group exhibited faster slough separation, new epidermis formation, and overall wound healing compared to the control group, with statistical significance. Visual analog scale (VAS) scores on postoperative days 3, 7, 9, and 14 were significantly lower in the experimental group than in the control group. Before treatment, there was no statistically significant difference in the levels of interleukin-17 (IL-17), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) between the two groups. However, after treatment, both groups exhibited a decrease in inflammatory markers, and the experimental group had significantly lower levels of IL-17, IL-6, and TNF-α compared to the control group). Furthermore, the incidence of adverse reactions in the experimental group (3.70%) was significantly lower than that in the control group (22.22%). Conclusion: The utilization of Kangfuxin Liquid gauze in wound healing after necrotizing fasciitis surgery effectively promotes wound healing, provides precise therapeutic effects, significantly reduces patient pain, improves inflammation, and exhibits minimal adverse reactions, thus demonstrating high safety. Therefore, the application of Kangfuxin Liquid gauze in this clinical context is highly recommended.

Efficacy and safety of mTOR inhibition in cutaneous sarcoidosis: a single-centre trial.

BACKGROUND: Sarcoidosis is an inflammatory condition that can affect various organs and tissues, causing the formation of granulomas and subsequent functional impairment. The origin of sarcoidosis remains unknown and there are few treatment options. Mechanistic target of rapamycin (mTOR) activation is commonly seen in granulomas of patients across different tissues and has been shown to induce sarcoidosis-like granulomas in a mouse model. This study aimed to examine the efficacy and safety of the mTOR inhibitor sirolimus as a treatment for cutaneous sarcoidosis. METHODS: We did a single-centre, randomised study treating patients with persistent and glucocorticoid-refractory cutaneous sarcoidosis with sirolimus at the Vienna General Hospital, Medical University of Vienna (Vienna, Austria). We recruited participants who had persistent, active, and histologically proven cutaneous sarcoidosis. We used an n-of-1 crossover design in a placebo-controlled, double-blind topical treatment period and a subsequent single-arm systemic treatment phase for 4 months in the same participants. Participants initially received either 0·1% topical sirolimus in Vaseline or placebo (Vaseline alone), twice daily. After a washout period, all participants were subsequently administered a 6 mg loading dose followed by 2 mg sirolimus solution orally once daily, aiming to achieve serum concentrations of 6 ng/mL. The primary endpoint was change in the Cutaneous Sarcoidosis Activity and Morphology Index (CSAMI) after topical or systemic treatment. All participants were included in the safety analyses, and patients having completed the respective treatment period (topical treatment or systemic treatment) were included in the primary analyses. Adverse events were assessed at each study visit by clinicians and were categorised according to their correlation with the study drug, severity, seriousness, and expectedness. This study is registered with EudraCT (2017-004930-27) and is now closed. FINDINGS: 16 participants with persistent cutaneous sarcoidosis were enrolled in the study between Sept 3, 2019, and June 15, 2021. Six (37%) of 16 participants were men, ten (63%) were women, and 15 (94%) were White. The median age of participants was 54 years (IQR 48-58). 14 participants were randomly assigned in the topical phase and 2 entered the systemic treatment phase directly. Daily topical treatment did not improve cutaneous lesions (effect estimate -1·213 [95% CI -2·505 to 0·079], p=0·066). Systemic treatment targeting trough serum concentrations of 6 ng/mL resulted in clinical and histological improvement of skin lesions in seven (70%) of ten participants (median -7·0 [95% CI -16·5 to -3·0], p=0·018). Various morphologies of cutaneous sarcoidosis, including papular, nodular, plaque, scar, and tattoo-associated sarcoidosis, responded to systemic sirolimus therapy with a long-lasting effect for more than 1 year after treatment had been stopped. There were no serious adverse events and no deaths. INTERPRETATION: Short-term treatment with systemic sirolimus might be an effective and safe treatment option for patients with persistent glucocorticoid-refractory sarcoidosis with a long-lasting disease-modulating effect. The effect of sirolimus in granulomatous inflammation should be investigated further in large, multi-centre, randomised clinical trials. FUNDING: Vienna Science and Technology Fund, Austrian Science Fund.

The application of a multi-component reaction peptide as a model regenerative active to enhance skin wound-healing postlaser procedure in a double-blinded placebo-controlled clinical trial.

INTRODUCTION: Esthetic procedures are currently among the most effective options for consumers seeking to correct aging signs such as fine lines, wrinkles, and skin tone unevenness. Currently, there is a scientific need for an adjunct active to be paired with esthetic procedures to encourage wound recovery and address postprocedure pigmentation concerns. OBJECTIVE: Toward that goal, this study assessed the efficacy of a peptide created from a multi-component reaction (multi-component peptide, MCP) as a model active for postprocedure care and evaluated its ability to promote skin healing in an ablative laser-induced wound model on the forearm. METHODS: The mechanism of action of MCP was investigated using tubo assays, 2D melanocyte, and fibroblast cultures, reconstructed skin equivalents, and ex vivo skin explants. The MCP formula and the clinical benchmark formula of Aquaphor were assessed head-to-head by applying the products topically in an ablative laser-induced wound model (n = 20 subjects). The promotion of wound healing was evaluated by the investigator assessment of epithelial confluence, crusting or scabbing, general wound appearance, erythema, and edema. RESULTS: MCP was determined to be beneficial to postprocedure skin recovery and healing by four main mechanisms of action: barrier repair as determined in an ex vivo tape-stripping model, reduction of inflammation and postinflammatory hyperpigmentation, reduction of elastase activity, and stimulation of fibroblast through the mTOR pathway. The formula containing 10% MCP enhanced the kinetics of epithelial confluence and improvement of the crusting or scabbing appearance of the laser-generated wounds in a laser-induced mini-zone wound healing study on the forearm. CONCLUSION: This study demonstrates the use of MCP as a proof of concept regenerative active that when incorporated into an optimized postprocedure skincare formula can improve skin healing and enhance the appearance of skin after injury with relevance to ablative aesthetic procedures.

More than just methylisothiazolinone: Retrospective analysis of patients with isothiazolinone allergy in North America, 2017-2020.

BACKGROUND: Isothiazolinones are a common cause of allergic contact dermatitis. OBJECTIVE: To examine the prevalence of positive patch test reactions to isothiazolinones from 2017-2020 and characterize isothiazolinone-allergic (Is+) patients compared with isothiazolinone nonallergic (Is-) patients. METHODS: Retrospective cross-sectional analysis of 9028 patients patch tested to methylchloroisothiazolinone (MCI)/methylisothiazolinone (MI) 0.02% aqueous, MI 0.2% aqueous, benzisothiazolinone (BIT) 0.1% petrolatum, and/or octylisothiazolinone (OIT) 0.025% petrolatum. Prevalence, reaction strength, concurrent reactions, clinical relevance, and source of allergens were tabulated. RESULTS: In total, 21.9% (1976/9028) of patients had a positive reaction to 1 or more isothiazolinones. Positivity to MI was 14.4% (1296/9012), MCI/MI was 10.0% (903/9017), BIT was 8.6% (777/9018), and OIT was 05% (49/9028). Compared with Is-, Is+ patients were more likely to have occupational skin disease (16.5% vs 10.3%, P <.001), primary hand dermatitis (30.2% vs 19.7%, P <.001), and be >40 years (73.1% vs 61.9%, P <.001). Positive patch test reactions to >1 isothiazolinone occurred in 44.1% (871/1976) of Is+ patients. Testing solely to MCI/MI would miss 47.3% (611/1292) of MI and 60.1% (466/776) of BIT allergic reactions. LIMITATIONS: Retrospective cross-sectional study design and lack of follow-up data. CONCLUSION: Sensitization to isothiazolinones is high and concurrent sensitization to multiple isothiazolinone allergens is common.

Petroleum jelly: A comprehensive review of its history, uses, and safety.

Petrolatum, also known as petroleum jelly, is a widely used topical agent, with a variety of uses in dermatology. Despite its popularity, many myths surround this ubiquitous dermatologic staple. This review details the history of petrolatum and how it is manufactured as well as how its biologic properties make it a great moisturizer. Additionally, data on its potential for flammability, allergenicity, and comedogenicity are detailed, dispelling misconceptions about petrolatum use around oxygen and as a cause of acne. The uses and benefits of petrolatum in dermatology are wide-ranging-a patch test instrument, a vehicle for medicated ointments, and a wound care essential. Given its ubiquitous presence, it is important for dermatologists to understand the history, safety profile, and myths surrounding this humble skincare staple.

Design of Ionic Liquid Formulations with Azone-Mimic Structures for Enhanced Drug Skin Permeation.

Although laurocapram (Azone) significantly enhances the skin permeation of drugs, its development was hindered by its skin irritation. We then developed an Azone-mimic ionic liquid (IL-Azone), composed of less irritating cationic ε-caprolactam and anionic myristic acid. IL-Azone dissociates to the original cation and anion in the presence of water in the formulation. We tried to select a formulation suitable for IL-Azone in the present study. Each formulation contained 5 % of either Azone or IL-Azone along with the model drug antipyrine, and skin permeation experiments of the drug were conducted. The results revealed that IL-Azone did not enhance skin permeation when combined with most formulations tested. However, a notable and rapid enhancement in skin permeation was observed when combined with white petrolatum. This effect could be attributed to the minimal water content in white petrolatum, which prevented IL-Azone degradation. Furthermore, its permeation-enhancing effects from IL-Azone in white petrolatum were more pronounced and rapid than Azone. The rapid onset observed with IL-Azone can be attributed to its degradation into its original components at the interface between the stratum corneum and the living epidermis, which results in a shorter lag time before achieving a steady-state concentration in the SC compared to Azone.

Impact of hydrocolloid dressings in the prevention of pressure ulcers in high-risk patients: a randomized controlled trial (PENFUP).

It is uncertain whether hydrocolloid dressings, a more costly intervention than offering standard care with petrolatum, is superior to prevent pressure ulcers among hospitalized high-risk adults. Randomized, parallel-group, open-label, superiority trial with an active control group, blinded for investigators, event validators, and analysts (December 1, 2015 to December 12, 2017). Eligible patients were ≥ 18 years of age with intact skin judged as high-risk for skin ulcers (Braden scale), admitted to surgical or medical wards of two tertiary-level hospitals. Participants were randomized (1:1) to protection with hydrocolloid dressings or petrolatum. The primary outcome was the first occurrence of pressure ulcers (with post-injury photographs adjudicated by three judges) under intention-to-treat analysis. Based on prior cost analysis, and the available resources (assumed incidence of 6 ulcers/1000 patient-days in controls), inclusion of up to 1500 participants allowed to surpass a one-sided superiority threshold > 5% based on a target efficacy > 40% for dressings. We planned an economic analysis using a decision tree model based on the effectiveness of the study results from a perspective of the third payer of health care. After inclusion of 689 patients (69 events), the trial was stopped for futility after a planned interim analysis (conditional power < 0.1 for all scenarios if the trial was completed). Pressure ulcers had occurred in 34 (10.2%) patients in the intervention group [9.6 per 1000 patient-days] and 35 (9.9%) participants in the control group [7.9 per 1000 patient-days], HR = 1.07 [95% CI 0.67 to 1.71]. The estimated incremental cost for dressings (a dominated strategy) was USD 52.11 per patient. Using hydrocolloid dressings was found similar to petrolatum for preventing pressure ulcers among hospitalized high-risk patients. As it conveys additional costs, and in this study was unlikely to demonstrate enough superiority, this strategy did not overcome conventional skin care.Trial registration: ClinicalTrials.gov identifier (NCT number): NCT02565745 registered on December 1, 2015.

Protective effect of nitroglycerin ointment and dimethyl sulfoxide on necrosis of skin flaps in rats.

OBJECTIVE: To compare the protective effect of nitroglycerin ointment 2% and Dimethylsulfoxide (DMSO) in dorsal flaps of the rat. METHODS: A blind, experimental study was conducted in 24 male Wistar rats, with a mean weight of 320 (286-376) grams. Group 1: Control. Petrolatum jelly (Vaseline), n = 8, Group 2: Nitroglycerin (NTG) ointment 2% (Nitro-Bid, Altana Co.) n = 8, and Group 3: DMSO gel 90% (Neogen corp. Lexington KY, 40611), n = 8. RESULTS: A total of 24 rats were operated on in the 6-month period of this study. Using a non-parametric Mann-Whitney U-test analysis, a statistically significant p was obtained between the control group and 2% NTG ointment, both in the area of necrosis and in the healthy area (p = 0.026). In contrast, the comparison between DMSO [CH3) 2SO] and the control group (p = 0.180) and between both study groups, with a p = 0.18, was not significant. CONCLUSIONS: Our study concluded that there is a protective effect of 2% NTG ointment for flap survival in relation to the control group (petrolatum). DMSO administered topically did not show a protective effect, compared to the control group.

OBJETIVO: Comparar el efecto protector del ungüento de nitroglicerina 2% y el dimetilsulfoxido 90% en colgajos dorsales en ratas. MÉTODOS: Se realizó un estudio experimental ciego en 24 ratas Wistar macho, con un peso medio de 320 gramos. Grupo 1: Control. Petrolato n = 8, Grupo 2: Nitroglicerina unguento al 2 % (Nitro-Bid, Altana Co.), n = 8, Grupo 3. Dimetilsulfóxido al 90% (Neogen corp. Lexington KY.), n = 8. RESULTADOS: Un total de 24 ratas fueron operadas en el período de 6 meses de este estudio. Mediante un análisis no paramétrico de la prueba U de Mann Whitney, se obtuvo una p estadísticamente significativa entre el grupo control y la pomada de nitroglicerina al 2%, tanto en el área de necrosis como en el área sana (p = 0.026). Por el contrario, la comparación entre DMSO y el grupo control (p = 0.180) y entre ambos grupos de estudio, con una p = 0.18, no fue significativa. CONCLUSIONES: Nuestro estudio concluyó que existe un efecto protector de la pomada de nitroglicerina al 2% para la supervivencia del colgajo en relación al grupo control (vaselina). El DMSO administrado por vía tópica no mostró un efecto protector, en comparación con el grupo de control.

Accelerated Wound Healing with a Diminutive Scar through Cocrystal Engineered Curcumin.

Pharmaceutical cocrystals ( Regulatory Classification of Pharmaceutical Co-Crystals Guidance for Industry; Food and Drug Administration, 2018) are crystalline solids produced through supramolecular chemistry to modulate the physicochemical properties of active pharmaceutical ingredients (APIs). Despite their extensive development in interdisciplinary sciences, this is a pioneering study on the efficacy of pharmaceutical cocrystals in wound healing and scar reducing. Curcumin-pyrogallol cocrystal (CUR-PYR) was accordingly cherry-picked since its superior physicochemical properties adequately compensate for limitative drawbacks of curcumin (CUR). CUR-PYR has been synthesized by a liquid-assisted grinding (LAG) method and characterized via FT-IR, DSC, and PXRD analyses. In vitro antibacterial study indicated that CUR-PYR cocrystal, CUR+PYR physical mixture (PM), and PYR are more effective against both Gram-negative (Pseudomonas aeruginosa and Escherichia coli) and Gram-positive (Staphylococcus aureus and Bacillus subtilis) bacteria in comparison with CUR. In vitro results also demonstrated that the viability of HDF and NIH-3T3 cells treated with CUR-PYR were improved more than those received CUR which is attributed to the effect of PYR in the form of cocrystal. The wound healing process has been monitored through a 15 day in vivo experiment on 75 male rats stratified into six groups: five groups treated by CUR-PYR+Vaseline (CUR-PYR.ung), CUR+PYR+Vaseline (CUR+PYR.ung), CUR+Vaseline (CUR.ung), PYR+Vaseline (PYR.ung), and Vaseline (VAS) ointments and a negative control group of 0.9% sodium chloride solution (NS). It was revealed that the wounds under CUR-PYR.ung treatment closed by day 12 postsurgery, while the wounds in other groups failed to reach the complete closure end point until the end of the experiment. Surprisingly, a diminutive scar (3.89 ± 0.97% of initial wound size) was observed in the CUR-PYR.ung treated wounds by day 15 after injury, followed by corresponding values for PYR.ung (12.08 ± 2.75%), CUR+PYR.ung (13.89 ± 5.02%), CUR.ung (16.24 ± 6.39%), VAS (18.97 ± 6.89%), and NS (20.33 ± 5.77%). Besides, investigating histopathological parameters including inflammation, granulation tissue, re-epithelialization, and collagen deposition signified outstandingly higher ability of CUR-PYR cocrystal in wound healing than either of its two constituents separately or their simple PM. It was concluded that desired solubility of the prepared cocrystal was essentially responsible for accelerating wound closure and promoting tissue regeneration which yielded minimal scarring. This prototype research suggests a promising application of pharmaceutical cocrystals for the purpose of wound healing.

A Retrospective Review of Anthralin in Petrolatum in the Treatment of Alopecia Areata in the Pediatric Population.

BACKGROUND/OBJECTIVES: Alopecia areata (AA) is a T-cell driven autoimmune disease, which results in hair loss. This study aims to determine the efficacy, tolerability and safety of different concentrations of anthralin in the treatment of pediatric AA. METHODS: A retrospective cohort study of patients < 18 yo diagnosed with AA treated with anthralin at SickKids Hospital, Toronto dermatology outpatient clinic in 2016 - 2018. Anthralin used at 0.1%, 0.2%, 0.5% and 1% in petrolatum at short contact, at increments of 15 minutes every week until a 1 hr maximum contact achieved. No other treatment was used in conjunction. Severity of Alopecia Tool (SALT) scores (SS) were determined using photographs and descriptions to assess severity of alopecia at baseline and post anthralin treatment. RESULTS: A total of 11 charts were reviewed in this retrospective cohort. Hair loss pattern; 3 patients with patchy, 6 had mixed (patchy and ophiasis), and 2 were totalis. All except for 1 patient had failed traditional treatments. One patient had complete hair regrowth, 3 showed more than 85% hair re-growth and 7 patients showed more than 75% hair regrowth, the average time for this to occur was 6.5 months. None of the patients experience serious side effects. CONCLUSIONS: Our study demonstrated the efficacy and tolerability of topical anthralin 0.1% to 1% in pediatric alopecia areata. In our study, anthralin 0.2% appears to offer the best performance and tolerability profile among the different concentrations used, with treatment course of at least 6 months in order to achieve more than 75% hair regrowth.

Prevention of atopic dermatitis in high-risk neonates via different types of moisturizer application: A randomized, blinded, parallel, three-group, phase II trial (PAF study).

BACKGROUND: The effectiveness of moisturizers in preventing infant atopic dermatitis (AD) remains unclear. We previously showed that using 2e moisturizer of commercial moisturizer (Shiseido Japan Co., Ltd.) at least once a day significantly prevented AD in infants as compared with as-needed petroleum jelly. This trial aimed to determine the effectiveness of twice- or once-daily application of Fam's Baby moisturizer (Fam's Inc.) in preventing AD compared with once-daily 2e moisturizer. METHODS: This trial was a single-centre, three-parallel-group, assessor-blinded, superiority, individually randomized, controlled, phase II trial that was conducted from 25 August 2020 to 28 September 2021. We randomly assigned 60 newborns with at least one parent or sibling who has AD to receive Fam's Baby moisturizer twice daily (Group A) or once daily (Group B), or 2e once daily (Group C) in a 1:1:1 ratio until they were 32 weeks old. The primary outcome was the time of AD onset. RESULTS: Atopic dermatitis was observed in 11/20 (55%), 5/20 (25%) and 10/20 (50%), infants in Groups A, B and C, respectively. Cumulative incidence values for AD according to the Kaplan-Meier method showed that infants in Group B tended to maintain an intact skin for a longer period than those in Group C (median time, not reached [NR] vs. 212 days, log-rank test, p = 0.064). Cox regression analysis showed that the risk of AD tended to be lower in Group B (hazard ratio with group C as control, 0.36; 95% confidential intervals: 0.12-1.06). No serious adverse events occurred in any of the enrolled infants. CONCLUSION: Fam's Baby moisturizer may better prevent AD than 2e. Further large-scale trials should be performed to confirm the efficacy of Fam's Baby moisturizer in preventing AD in infants.

Investigating the role of Zibai ointment on apoptosis-related factors Bcl-2 and Bax in wound healing after anal fistula surgery.

OBJECTIVE: In this study, we investigated the impact of Zibai ointment on wound healing by analyzing the expression levels of two key apoptosis-related factors-B-cell lymphoma 2 (Bcl-2) and Bcl-2-associated X protein (Bax), in patients following surgery for anal fistula. METHODS: We included 90 patients with anal fistulas who were treated in the People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine. Patients were randomly assigned to receive treatment with Zibai ointment (n = 45) or petroleum jelly (n = 45). The levels of apoptosis-related factors Bcl-2 and Bax were evaluated using enzyme-linked immunosorbent assay (ELISA), while cell apoptosis was assessed using Terminal deoxynucleotidyl transferase (TdT) dUTP Nick-End Labeling (TUNEL) assay. RESULTS: The results of ELISA showed that on Day 21 after the surgery, the levels of Bcl-2 and Bax in the Zibai ointment group were significantly different compared to the petroleum jelly group, with values of (60.11 ± 1.31) ng/mL and (7.05 ± 0.01) versus (83.79 ± 1.74) ng/mL and (6.00 ± 0.05) ng/mL, respectively (p < .05). Furthermore, light microscopy revealed a large number of apoptotic cells within the field of vision 14 days postsurgery in the Zibai ointment group, and the healing time in the Zibai ointment group was significantly different from that in the petroleum jelly group (p < .05). CONCLUSION: We found that Zibai ointment effectively promoted wound healing in patients following anal fistula surgery, possibly by regulating Bcl-2 and Bax apoptosis-related factors.

[Homogeneity of Two Semisolid Formulations Using Simple In-tube Mixing Method].

To accelerate therapeutic effects, the mixtures of two or more topical pharmaceutical products having different medicinal purposes are often applied in the medical field. In this study, we aimed to develop a simple mixing method/procedure to achieve excellent homogeneity in the mixture of two topical products, a steroidal ointment and a skin moisturizer. To assess an in-tube mixing method as a simple mixing procedure, we injected both topical products into an empty resin tube, a flexible hollow tube with an open end that can be closed on one side, and a closed end on the other, removed as less air as possible inside the tube, and then thermocompressed (sealed) the open end to close it. The two topical products were then mixed uniformly by repeated finger pressure along the longitudinal axis of the tube. The homogeneity of the two topical products in the tube was evaluated by measuring the content of methyl paraoxybenzoate (MP), an additive loaded in the skin moisturizer. In addition, the mixability was qualitatively evaluated from the distribution of white petrolatum, another additive loaded in the steroid ointment, using Raman spectroscopy. As a result, the measured value of MP relative to the label claim was in the range of 100±12%, and the coefficients of variation value was also less than 12%. These results indicate that the in-tube mixing method using two topical products is approximately hologenetic preparations that do not cause therapeutic problems.

Perceptions, beliefs, and current practices regarding neonatal skin care and emollient use in eastern Uganda: a qualitative study.

BACKGROUND: The skin is a major route of infection in the neonatal period, especially in low birthweight (LBW) infants. Appropriate and safe neonatal skin care practices are required to reduce this risk. The perceptions and beliefs of mothers and other caregivers towards various neonatal skin care practices in our setting have been documented. Data from Asia suggests that the application of emollient to the skin of LBW infants can promote growth, reduce serious neonatal infections, and potentially reduce mortality. This is the first study to explore the acceptability of emollients and massage as part of neonatal skin care in a low-resource setting in sub-Saharan Africa (SSA) that is representative of the majority of government health facilities in Uganda and many in SSA. OBJECTIVE: To explore perceptions, beliefs, and current practices regarding neonatal skin care and emollient use in eastern Uganda. METHODS: We conducted a qualitative study consisting of three focus group discussions (30 participants), eight in-depth interviews with mothers/caregivers of preterm and term neonates and 12 key informant interviews with midwives, doctors and community health workers involved in neonatal care, to explore the perceptions and practices surrounding neonatal skin care and emollient use. Data collected were transcribed and analyzed using thematic content analysis. RESULTS: Mothers perceived that skin care began in utero. Skincare practices depended on the place of delivery; for deliveries in a health facility the skincare practices were mainly based on the health worker's advice. Vernix caseosa was often washed off due to its perceived undesirability and was attributed to sexual intercourse in the last trimester. Despite their deleterious attributes found in previous studies, petrolatum-based oils, petrolatum-based jellies and talcum baby powders were the most commonly reported items used in neonatal skin care. In our population, there was high acceptability of emollient therapy use; however, neonatal massage was treated with scepticism as mothers feared damaging the vulnerable neonate. Mothers suggested massage and emollient application be undertaken by health workers, if it becomes an intervention. CONCLUSIONS: In eastern Uganda, the perceptions and beliefs of mothers/caregivers toward neonatal skincare influenced their practices of which some could potentially be beneficial, and others harmful. Emollient use would be easily accepted if adequate sensitisation is conducted and using the gatekeepers such as health workers.

Development of an in vitro Functional Assay to Evaluate the Occlusive Properties of Moisturizers on Dry Skin.

INTRODUCTION: Dry skin is a hallmark of impaired skin barrier function. Moisturizers are a mainstay of treatment to help the skin retain moisture, and there is a high consumer demand for effective products. However, the development and optimization of new formulations are hampered due to lack of reliable efficacy measures using in vitro models. METHODS: In this study, a microscopy-based barrier functional assay was developed using an in vitro skin model of chemically induced barrier damage to evaluate the occlusive activity of moisturizers. RESULTS: The assay was validated by demonstrating the different effects on barrier function between humectant (glycerol) and occlusive (petrolatum). Significant changes in barrier function were observed upon tissue disruption, which was ameliorated by commercial moisturizing products. CONCLUSION: This newly developed experimental method may be helpful to develop new and improved occlusive moisturizers for the treatment of dry skin conditions.