Topical Treatment Of Patients Research Articles

Effectiveness of antibacterial therapeutic clothing vs.nonantibacterial therapeutic clothing in patients withmoderate-to-severe atopic dermatitis: arandomizedcontrolled observer-blind pragmatic trial(ABC trial).

Increased Staphylococcus aureus (SA) colonization is considered an important factor in the pathogenesis of atopic dermatitis (AD). Antibacterial therapeutic clothing aims to reduce SA colonization and AD inflammation; however, its role in the management of AD remains poorly understood. To investigate the effectiveness of antibacterial therapeutic clothing + standard topical treatment in patients with moderate-to-severe AD vs. standard therapeutic clothing + standard topical treatment; and, if effectiveness was demonstrated, to demonstrate its cost-effectiveness. A pragmatic double-blinded multicentre randomized controlled trial (NCT04297215) was conducted in patients of all ages with moderate-to-severe AD. Patients were centrally randomized 1 : 1 : 1 to receive standard therapeutic clothing or antibacterial clothing based on chitosan or silver. The primary outcome was the between-group difference in Eczema Area and Severity Index (EASI) measured over 52weeks. Secondary outcomes included patient-reported outcomes (PROs), topical corticosteroid (TCS) use, SA colonization, safety and cost-effectiveness. Outcomes were assessed by means of (generalized) linear mixed-model analyses. Between 16 March 2020 and 20 December 2021, 171 patients were enrolled. In total, 159 patients were included (54 in the standard therapeutic clothing group, 50 in the chitosan group and 55 in the silver group). Adherence was high [median 7 nights a week wear (interquartile range 3-7)]. Median EASI scores at baseline and at 4, 12, 26 and 52 weeks were 11.8, 4.3, 4.6, 4.2 and 3.6, respectively, in the standard therapeutic clothing group vs. 11.3, 5.0, 3.0, 3.0 and 4.4, respectively, in the chitosan group, and 11.6, 5.0, 5.4, 4.6 and 5.8, respectively, in the silver group. No differences in EASI over 52 weeks between the standard therapeutic clothing group, the chitosan group [-0.1, 95% confidence interval (CI) -0.3 to 0.2; P = 0.53] or the silver group (-0.1, 95% CI -0.3 to 0.2; P = 0.58) were found. However, a small significant group × time interaction effect between the standard and silver groups was found (P = 0.03), in which the silver group performed worse after 26 weeks. No differences between groups were found in PROs, TCS use, SA skin colonization and healthcare utilization. No severe adverse events or silver absorption were observed. The results of this study suggest no additional benefits of antibacterial agents in therapeutic clothing in patients with moderate-to-severe AD.

Improving effectiveness of topical treatment in patients with vitiligo in lighter skin types by marking out skin lesions using ultraviolet lamps

Improving effectiveness of topical treatment in patients with vitiligo in lighter skin types by marking out skin lesions using ultraviolet lamps

FT-IR Analysis of Structural Changes in Ketoprofen Lysine Salt and KiOil Caused by a Pulsed Magnetic Field.

High-intensity, low-frequency magnetic fields (MFs) have been widely used in the treatment of diseases and in drug delivery, even though they could induce structural changes in pharmacological molecules. Morphological changes in ketoprofen and KiOil were investigated through Fourier-transform infrared spectroscopy (FT-IR). Unsupervised principal component analysis was carried out for data clustering. Clinical validation on 22 patients with lower back pain was managed using diamagnetic therapy plus topical ketoprofen or KiOil. The Numerical Rating Scale (NRS) and Short-Form Health Survey 36 (SF-36) were used to evaluate clinical and functional response. Ketoprofen showed clear clustering among samples exposed to MF (4000–650 cm−1), and in the narrow frequency band (1675–1475 cm−1), results evidenced structural changes which involved other excipients than ketoprofen. KiOil has evidenced structural modifications in the subcomponents of the formulation. Clinical treatment with ketoprofen showed an average NRS of 7.77 ± 2.25 before and an average NRS of 2.45 ± 2.38 after MF treatment. There was a statistically significant reduction in NRS (p = 0.003) and in SF-36 (p < 0.005). Patients treated with KiOil showed an average NRS of 7.59 ± 2.49 before treatment and an average NRS of 1.90 ± 2.26 after treatment (p < 0.005). SF-36 showed statistical significance for all items except limitations due to emotional problems. A high-intensity pulsed magnetic field is an adjunct to topical treatment in patients with localized pain, and the effect of MF does not evidence significant effects on the molecules.

Long-term clinical efficacy of topical treatment with recombinant human nerve growth factor in neurotrophic keratopathy: a novel cure for a rare degenerative corneal disease?

BackgroundNeurotrophic keratopathy (NK) is a rare, degenerative ocular disease characterized by reduction or loss of corneal sensitivity and development of non-healing corneal epithelial defects and ulcers. Cenegermin, a recombinant human nerve growth factor (rhNGF) eye drop solution, is the first drug approved for the treatment of NK. The aim of our study is to evaluate the long-term efficacy of this innovative topical treatment in patients with NK.MethodsRetrospective, consecutive, observational case series study from a single-center setting (Department of Sense Organs, University Sapienza of Rome, Rome, Italy). 18 patients with diagnosis of stage 2 or 3 NK, treated with Cenegermin 20 mcg/ml eye drops were followed for up to 48 months. Recurrence of lesion during follow-up was evaluated at 12, 24, 36, and 48 months. In addition, corneal sensitivity, Schirmer tear test, and visual acuity (VA) were recorded at baseline, end of treatment, and at 12, 24, 36, and 48 months.ResultsThree patients experienced recurrence of persistent epithelial defects (PEDs) within 12 months and one patient experienced recurrence of a corneal ulcer within 36 months. Corneal sensitivity was significantly improved at all timepoints (P < 0.05). Significant improvements in visual acuity and tear production were seen at the completion of treatment as well as at 12, 24, and 36 months (P < 0.05) when compared to baseline.ConclusionsA single 8-week treatment regimen of Cenegermin eye drops has clinical efficacy that can persist for up to 48 months. The long-term clinical utility of treatment with Cenegermin for NK was demonstrated through the low rate of lesion recurrence along with improvements in corneal sensitivity and tear production.

Evaluation of EOS Gene Expression and IL-6 Serum Levels in Iraqi Patients with Psoriasis

Background: EOS (encoded by the IKZF4 gene) is a member of the zinc finger transcription factor IKaros family, and plays a critical role in Treg suppressor functions, and maintaining Treg stability. IL-6 is a soluble mediator with a pleiotropic effect on inflammation, immune response, and hematopoiesis. Aim: To estimate serum IL-6 level and EOS gene expression in Iraqi patients with psoriasis. Method: Twenty-two patients with psoriasis (8 females, 14 males) with age ranged 18-72 years, were recruited from Baghdad Teaching Hospital, Dermatology Clinic, Baghdad, and 24 healthy donors. The serum levels of IL-6 by ELISA and the gene expression of IKZF4 (EOS gene) by RT-qPCR technique. Results: The results showed a non-significant difference in the level of IL-6 in those treated with topical therapy and others treated with Etanercept compared to control. A non-significant increase in patients treated with topical therapy was reported compared to patients treated with Etanercept. There was a higher significant percentage of IKZF4 gene expression folding in psoriasis patients treated with Etanercept compared to control group, while no significant differences reported between patients treated with topical therapy, Etanercept, and the control group. Conclusion: Activation of Regulatory T cells (Tregs) with Etanercept enhances EOS expression and decreases IL-6 production more than topical treatment in patients with psoriasis.

Chinese expert consensus on selective internal radiation therapy with yttrium-90 for primary and metastatic hepatocellular carcinoma

Liver malignant tumors are one of the most common causes of cancer-related deaths in China. Selective internal yttrium-90 radioembolization therapy ((90)Y-SIRT) is a kind of promising local minimally invasive method, and its effectiveness and safety has been confirmed in clinical application over the past two decades. Moreover, it has been approved by the U.S. National Comprehensive Cancer Network and other international guidelines for the topical treatment of patients with liver malignancies. Taking into account the complexity of the (90)Y-SIRT and the need for multidisciplinary collaboration to improve the safety and success rate of treatment, the Nuclear Medicine Expert Committee of the Chinese society of Clinical Oncology, along with Beijing Nuclear Medicine Quality Control and Improvement Center invited experts from surgical oncology, interventional medicine, nuclear medicine, and other related fields to discuss and form a consensus on the clinical diagnosis, treatment and management, which mainly included definition, indications and contraindications, treatment procedures, postoperative follow-up, adverse reactions and complications, radiation safety management, etc. Herein, we provide the reference guidance to establish (90)Y-SIRT standardized management and treatment system various units for relevant practitioners.

Beneficial effects of an alkaline topical treatment in patients with mild atopic dermatitis.

Atopic dermatitis (AD) is the most common cause of eczema. The skin condition affects millions of people worldwide. Severe cases of AD demand systemic treatment, but most AD cases rely on local therapy with topical corticosteroids, emollients, and moisturizing agents to alleviate eczema. Commonly, derma-cosmetics with a pH around 5.5 are used to treat eczematous lesions (EL). However, evidence is currently amassing that the use of mildly alkaline topical creams is beneficial for AD-related eczema treatment because of its effect on the inflammation in the skin. To test an alkaline two-phase care concept for the treatment of eczema. An open-label study of 25 patients with eczema associated with mild AD. Patients were treated with Alkaline Build Up Caring Cream INTENSIVE and Alkaline Build Up Caring Cream PLUS+ (both Siriderma® ) for eight weeks. Dermatological, biochemical, and questionnaire-based examinations were conducted prior to the trial and after its completion. Topical administration of slightly alkaline creams led to small and statistically insignificant increases of skin pH. Clinical examination at the end of the observation period revealed a significant decrease of total eczematous-affected skin area, a significant decrease in average severity scores of EL, and significant improvements in patient-reported outcome parameters. Blood tests did not reveal any significant changes, except for small but significant increases in IL-8 and monocytes. Mildly alkaline topical creams seem to provide soothing effects on eczema-related skin inflammation and thus might contribute to treatment of local symptoms of eczema in patients with mild AD.

Tacrolimus 0.03% ointment treatment in exfoliative cheilitis: A randomised controlled clinical trial and monitoring blood concentration.

Tacrolimus has been used to treat various inflammatory skin diseases, but its safety for topical application on the oral mucosa is unknown. Exfoliative cheilitis (EC) is a chronic inflammatory disorder of the lips characterised by repeated scaling; it is difficult to manage. The aim of this study was to assess the efficacy and safety of tacrolimus 0.03% ointment as a topical treatment in patients with EC. In this randomised controlled clinical trial, 40 patients with EC were randomly assigned to receive either tacrolimus 0.03% ointment (experimental group, n=20) or triamcinolone acetonide 0.1% cream (control group, n=20) treatment for a 3-week period. Medication was administered in 3, 2 and 1 daily doses during the first, second and third weeks, respectively. The patients with complete healing were followed up for 3months. The clinical outcomes were measured, including the scores regarding signs (scale, dryness, rhagades and swelling) and symptoms (rough, dry, pain, pruritus and burning sensation) at every visit. Blood concentrations of tacrolimus were assessed. After the 3-week treatment, healing rates of scale in the experimental and control groups were 65% and 10%, respectively (P=.018). Improvement in all signs and two symptoms (rough, pruritus) was much greater in the experimental group (P<.05). The 3-month recurrence rate was higher in the control group (P=.029). Tacrolimus blood concentrations were in the safe range (< 5ng/mL). Topical tacrolimus 0.03% ointment has good short-term efficacy and safety for treating EC.

18726 Measuring and improving adherence to topical crisaborole in patients with atopic dermatitis

Background: Long-term adherence to topical treatment in patients with atopic dermatitis (AD) is not well characterized. Measures to improve adherence could improve treatment outcomes.

Complex topical treatment of patients with infectious and inflammatory pharyngeal pathology

Pharyngalgia is one of the most common complaints in both children and adults seeking medical advice. The causes of throat discomfort and pain vary and are explained by anatomo-physiological characteristics of pharynx. The lesion of pharyngeal mucosa and mucosal associated lymphoid tissue develops in 80% of acute respiratory disease cases. Detailed history taking and additional tests are required to confirm the etiology of pharyngalgia that is not related to respiratory infection and to provide appropriate treatment for the patient. Fixed topical combination with complex effectiveness established itself as a leading choice of inflammatory pharynx diseases treatment. Such treatment has the following advantages: the precise point of drug effect, minimal amount of side effects or its complete absence and risk reduction of general micro biome affection. The treatment should also be able to reach hard-to-reach areas and have good sensory properties. The purpose of topical treatment in patients with pharyngeal pathology is to relieve pain quickly, to reduce the inflammation and to prevent secondary infection of mucosa. The drug containing tyrothricin as antibiotic, benzocaine as antiseptic provides antibacterial and benzalkonium chloride as antiseptic, antiviral and analgetic effects. Not only do the early diagnosis and treatment meet the need of the patient to relieve the symptoms quickly but also have a positive impact on disease course and prevent the development of complications.

Effectiveness of color and picture labeling in improving the knowledge on topical medications among patients with psoriasis: A randomized controlled trial.

ABSTRACTAim and Objective:The success of topical treatment in patients with psoriasis is still below par in Malaysia. The contributing factors include patients’ understanding and knowledge about prescribed topical medications. The aim of this study was to assess the effectiveness of color and picture labeling (C and P labeling) in improving the knowledge about topical medications among patients with psoriasis.Materials and Methods:An unblinded randomized controlled trial was undertaken at the dermatology clinic of a tertiary care hospital. Consent from the patients fulfilling inclusion criteria were obtained, and they were included in this study. They were randomized into two groups, namely Gp-1 (C and P labeling) and Gp-2 (conventional labeling). Both groups were assessed at week 0, 6, and 12 (visit 1, 2, and 3) using knowledge assessment list and psoriasis severity assessment score. For visit 2 (week 6), reinforcement of their understanding of topical treatment was performed.Results:A total of 101 patients were recruited. Only 91 of them completed the study. The mean ages were 44.52 (±16.61) and 45.49 (±15.84) years, with 70.3% males and approximately half Malay ethnics. The changes of knowledge and comparison of Topical Application Assessment Score between the groups showed an incremental raise of significance with every visit (P = 0.006 [week 1], 0.004 [week 6], and 0.002 [week 12]). Psoriasis Area and Severity Index 75 could not draw any conclusion as patients who achieved >75% improvement were inadequate.Conclusion:C and P labeling was effective in improving the understanding and knowledge of patients with psoriasis. Both groups showed improvement in body surface area and Dermatology Life Quality Index for every visit; however, it was statistically insignificant.

Rational approach to choice of topical therapy of patients with onychomycosis

Objective — to increase the efficacy of treatment of patients with onychomycosis by appointing topical therapy with Onychocid® Emtrix complex.Materials and methods. The analysis of modern research on the prevalence of onychomycosis, features of clinical course and methods of treatment was conducted.Results and discussion. Onychomycoses are extremely widespread, long­lasting and have toxic and sensitizing action of fungal infection on the patient’s body. The incidence of onychomycoses increases with age, reaching a maximum in the elderly and old age. The drug of choice for topical treatment of onychomycosis is a complex drug Onychocid® Emtrix, which is characterized by efficiency and safety.Conclusions. Complex drug Onychocid® Emtrix is a drug of choice for topical treatment of patients with onychomycosis. It can be recommended as monotherapy for patients with concomitant somatic pathology.

Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo

Ozenoxacin, a novel topical antibacterial agent with potent bactericidal activity against gram-positive bacteria, has been developed as a cream with 1% active drug for the treatment of impetigo, a highly contagious bacterial skin infection. To evaluate the efficacy, safety, and tolerability of ozenoxacin cream, 1%, after 5-day twice-daily topical treatment in patients with impetigo. This randomized, double-blind, vehicle-controlled clinical trial included patients 2 months or older with impetigo who were enrolled at centers in 6 countries from June 2, 2014, through May 30, 2015. Data were analyzed based on intention to treat from July 9 through July 22, 2015. Patients were randomized 1:1 to receive topical ozenoxacin or placebo control. Efficacy was measured using the Skin Infection Rating Scale and microbiological culture. Safety and tolerability were also evaluated. Among the 411 patients who received treatment (210 males [51.1%]; mean [SD] age, 18.6 [18.3] years), ozenoxacin demonstrated superior clinical success compared with placebo, which was evident after 5 days of therapy (112 of 206 [54.4%] vs 78 of 206 [37.9%]; P = .001). Ozenoxacin also demonstrated superior microbiological success compared with placebo after 2 days of therapy (109 of 125 [87.2%] vs 76 of 119 [63.9%]; P = .002). Ozenoxacin was well tolerated, with 8 of 206 patients experiencing adverse effects, with only 1 of these potentially related to the study treatment; none were serious. Topical ozenoxacin is effective and well tolerated in the treatment of impetigo in patients 2 months and older. This effect is demonstrated by rapid onset of response and superior clinical and microbiological response compared with placebo. Topical ozenoxacin represents a novel option for the treatment of impetigo. ClinicalTrials.gov Identifier: NCT02090764.

A pilot single centre, double blind, placebo controlled, randomized, parallel study of Calmagen\xae dermaceutical cream and lotion for the topical treatment of tinea and onychomycosis

BackgroundMost of the current anti-fungal treatments are chemical-based, fungistatic, have low efficacy in the treatment of tinea and toxicity concerns, while onychomycosis remains recalcitrant to most antifungal therapies. The study aimed to establish the fungicidal, efficacy and safety profile of Calmagen® dermaceutical cream and lotion containing AMYCOT® as a topical treatment in patients with severe to very severe presentations of fungal skin (tinea) and nail infections (onychomycosis).MethodsA randomized, placebo-controlled, double blind, parallel, single centre study was conducted on 28 subjects with severe to very severe tinea or onychomycosis. All patients were randomized in a ratio of 1:1 for treatment or placebo group. Subjects in the treatment arm received Calmagen® cream or lotion, while subjects in the placebo arm received a similar inert topical preparation. Tinea subjects were treated with cream for four weeks, while onychomycosis subjects were treated with lotion for 12 weeks. Mycological cure, the primary endpoint, was assessed by three parameters: KOH (potassium hydroxide) smear, fungal culture and live spore count. Clinical cure was defined as Investigator Global Assessment (IGA) response of ‘cleared’ or ‘excellent’.ResultsAll three parameters constituting mycological cure were confirmed in 92.8% (13/14) of subjects in the treatment arm, while all 14 subjects in the placebo arm remained positive for KOH smear. Calmagen® cream and lotion treatment showed a significant improvement in all three parameters: KOH smear, (95% CI (Calmagen): 79.4, 100.0; 95% CI (placebo): 0.0, 0.0; p < 0.0001); fungal culture (95% CI (Calmagen); 100.0, 100.0; 95% CI (Placebo): 17.0, 100.0; p < 0.0019); and live spore count (95% CI (Calmagen): 100.0, 100.0; 95% CI (Placebo): 17.0, 100.0; p < 0.0019). Clinical cure was achieved in all subjects in the treatment arm while none in the placebo arm were clinically cured. No treatment-related adverse effects were observed in either group.ConclusionsThe Calmagen® cream and lotion containing AMYCOT® represent a potentially safe and efficacious natural alternative in the treatment of Tinea and onychomycosis.Trial registrationThis trial has been registered with the clinical trial registry-India (CTRI; registration number: CTRI/2012/03/002522).

Efficacy of nutritional supplementation with omega-3 and omega-6 fatty acids in dry eye syndrome: a systematic review of randomized clinical trials.

To critically appraise scientific evidence regarding the efficacy of nutritional supplementation with omega-3 and omega-6 fatty acids for the treatment of dry eye syndrome (DES). A systematic review of randomized clinical trials was performed. Two independent reviewers selected and analysed the scientific papers that met inclusion and exclusion criteria. Objective and subjective efficacy outcomes were assessed. The trials involved a total of 2591 patients in fifteen independent studies. All studies were published between 2005 and 2015. The supplements used were mostly omega-3 and omega-6 in different proportions. Subjective improvement was measured using mainly Ocular Surface Disease Index (OSDI) test and Dry Eye Severity Score (DESS) test: significant differences in favour of the experimental group were found in seven of the studies. The objective amelioration was assessed by lacrimal function parameters: Tear break-up time (TBUT) significantly increased in nine studies and Schirmer's test in four studies. We observed a discrete improvement in the parameters of tear function. Scientific evidence is not strong enough to systematically recommend the use of omega-3 and omega-6 fatty acids as a standalone treatment of DES independently from its aetiology. However, they could be considered as an effective alternative to topical treatment in patients with DES secondary to certain pathologies.

Development and Validation of a Novel Questionnaire for Adherence with Topical Treatments in Psoriasis (QATOP).

Self-report measures are the most used methodologies for the evaluation of adherence to psoriasis topical treatment, although currently there is no standard questionnaire for this purpose. The present study aimed at developing a novel questionnaire (Questionnaire for Adherence to TOPical treatment [QATOP]) for the assessment of adherence to topical treatment in psoriasis. A questionnaire containing nine items organized into two parts (part 1: current patient treatment; part 2: adherence to treatment, amount used, and treatment-associated variables) was developed, supported by a systematic literature review, qualitative patient focus interviews, and expert-group input. Its content validity was determined by a pilot study of six patients. Adherence to topical treatment was then assessed in 35 patients with psoriasis, after 45 days of treatment, using the QATOP and a medication log. Associations between different items of the QATOP and the log were investigated. Adherence results were 63.5±29.2% for the log and 60.9±24.4% for the QATOP, and were strongly correlated (R=0.819, p<0.001). Distinct posologic regimens were reported by patients, which, in some cases, were not the usual doses. Patients also reported using doses of medicine on each application that were markedly lower than required. The QATOP is a valid and reliable self-report measure of adherence to topical treatment in patients with psoriasis. The use of this standard questionnaire could improve the methodological quality of adherence studies. Improvement of the clarity of posologic instructions is clearly urgently needed.

Field Cancerisation Improvement with Topical Application of a Film-Forming Medical Device Containing Photolyase and UV Filters in Patients with Actinic Keratosis, a Pilot Study

Background: Actinic keratoses (AKs) are considered to be a ‘field of cancerization’ consisting of a histologically abnormal epithelium adjacent to tumour tissue. Treatment of the ‘field of canceri-zation’ is important for the prevention of neoplasm progression. UV radiation, especially UVB, produce genotoxic photoproducts such as cyclobutane pyrimidine dimers (CPDs) and 6-4 photo-products (6-4PPs) in DNA, being major players in skin cancerization. The potential use of DNA photolyases in skin cancer prevention is increasingly being demonstrated. Topical application of a liposome formulation containing CPD photolyase onto human skin provides protection against UV-B-induced damages. Objectives: To assess the effects of topical application of a medical device (Eryf-AK) containing a DNA-repair enzyme, photolyase, encapsulated in liposomes and UV filters, on cancerization field in actinic keratosis (AK). Methods: 13 AK patients were included. Clinical, dermoscopic, and reflectance confocal microscopy (RCM) assessments, as well as skin biopsies, before and after a 4-week treatment were performed. Patients used Eryf-AK twice daily or only a sunscreen (3:1) with a similar sun protection factor (SPF) for one month. Results: Erythema and scaling improved with Eryf-AK. RCM showed a reduction in scaling, detached corneocytes and polygonal nucleated cells in the stratum corneum (p=0.004, p=0.018, and p=0.021), an improvement of the atypical honeycomb pattern, and a decreased number of round nucleated cells at the spinous granulous layer (p<0.0005 and p=0.019) with Eryf-AK while no improvement was noted with the sunscreen product. The mean RCM score for AK significantly improved from 0.78 to 0.27 (p=0.002) with Eryf-AK. Histological clearance of AK in 4 cases and an improvement with a focal AK associated with inflammation in 3 additional patients were also observed with Eryf-AK. A decrease in p21 expression (p=0.042) and a tendency to decrease PCNA expression was also observed with Eryf-AK (p=0.076). Conclusion: Our results show a benefit from Eryf-AK in the treatment of AK cancerisation field. The improvement was demonstrated clinically, by RCM, histologically and by immunohistochemistry. An improvement was also observed in the two patients with xeroderma pigmentosum, suggesting a benefit from this topical treatment in patients with this rare genetic disorder.

Treatment of patients with chemotherapy-induced PPE using a prevention ointment containing high concentrations of antioxidants.

e19558 Background: The palmar-plantar erythrodysesthesia syndrome (PPE) is a cutaneous side effect often observed in patients under chemotherapy, e.g., with pegylated liposomal doxorubicin. This side effect entails a reduction in the antioxidative potential of the skin due to intensive radical formation. Recently, it was demonstrated that topical treatment of patients with an ointment containing high concentrations of antioxidants is an efficient prevention strategy against PPE when applied before the beginning of chemotherapy. In a 5-year observation period at the Department of Dermatology of the Charité we selected patients, who had developed a PPE during treatment with a variety of chemotherapeutics. The aim of the present study was to investigate whether the antioxidant containing ointment is also suited to treat PPE, which occurred during treatment of 13 types of cancer with chemotherapeutics besides doxorubicin. Methods: In 5 years, 68 patients having developed PPE during treatment with 12 different chemotherapeutics, including pegylated liposomal doxorubicin, capecitabin and sorafenib applied an ointment containing antioxidants with a high radical protection factor (RPF). 46 patients exhibited PPE grade III and 22 patients PPE grade II. All patients were treated with the antioxidant-containing ointment, which was applied at least twice daily in the palmar and plantar regions. Results: Treatment with the antioxidant-containing ointment resulted in a distinct regression or disappearance of PPE. After 4 weeks of treatment the PPE grade III originally diagnosed in 46 patients had reduced to grade II in 6 and to grade I in 33 patients. In 7 patients the PPE had completely disappeared. The PPE grade II diagnosed in 22 patients had alleviated to grade I in 7, and completely disappeared in 15 patients. Conclusions: Obviously, cutaneous side effects entailing radical formation processes are also induced by other types of chemotherapeutics. An antioxidant containing ointment with high RPF is not only suited to prevent PPE in patients under doxorubicin therapy, but is also effective in treating PPE caused by other chemotherapeutics.

A phase IIIb, multicentre, randomized, double-blind, vehicle-controlled study of the efficacy and safety of adalimumab with and without calcipotriol/betamethasone topical treatment in patients with moderate to severe psoriasis: the BELIEVE study

Data are lacking on the use of topical therapies in combination with tumour necrosis factor blockers for the treatment of psoriasis. To assess the efficacy and safety of adalimumab (ADA) with topical calcipotriol/betamethasone (C/B) in patients with psoriasis resembling those treated in routine clinical practice. A 16-week, randomized, vehicle-controlled trial was conducted in patients with moderate to severe psoriasis and previous failure, intolerance or contraindications to two or more systemic treatments. All patients received ADA (80 mg, week 0; 40 mg every other week, weeks 1-15) in addition to either topical C/B or drug-free vehicle applied once daily for 4 weeks, and as needed thereafter. The primary endpoint was 75% improvement from baseline in Psoriasis Area and Severity Index (PASI 75) at week 16. A total of 730 patients received either ADA + C/B (n = 366) or ADA + vehicle (n = 364). PASI 75 response was initially higher with the combination therapy [14.8% for ADA + C/B vs. 5.8% for ADA + vehicle at week 2 (P < 0.001); and 40.7% vs. 32.4%, respectively, at week 4 (P = 0.021)]. After week 4, the trend was towards a higher response with ADA monotherapy, with no statistical difference in the PASI 75 response at week 16 (64.8% for ADA + C/B vs. 70.9% for ADA monotherapy, P = 0.086). Safety findings were consistent with previous ADA trials. ADA + C/B resulted in more rapid and higher efficacy within the first 4 weeks; thereafter, the trend was towards a higher response with ADA monotherapy. There was no statistical difference in the PASI 75 response at week 16. Both treatment regimens were well tolerated.

Stealth monitoring of adherence to topical medication: Adherence is very poor in children with atopic dermatitis

Atopic dermatitis is a common problem for which topical agents are the primary treatment. When topical medications fail, further therapy may include systemic agents with the potential for greater toxicity. Adherence to topical treatment of atopic dermatitis has not been well characterized. Poor adherence to topical medication could account for failure of topical therapy. To determine adherence to topical treatment in patients with atopic dermatitis. Thirty-seven children were given 0.1% triamcinolone ointment and were counseled to use it twice daily. They were told to return in 4 weeks, at which time they were told to continue treatment for another 4 weeks. Electronic monitors were used to measure adherence over the entire 8 week study. Patients were not informed of the compliance monitoring until the end of the study. Twenty-six patients completed 8 weeks of treatment. Mean adherence from the baseline to the end of the study was 32%. Adherence was higher on or near office visit days and subsequently decreased rapidly. This study was limited by the large number of subjects who failed to return for follow-up appointments or withdrew from the study. Adherence to topical medications is very poor in a clinic population of children with atopic dermatitis. Office visits are one means to increase adherence. If adherence to topical treatment can be improved, exposure to more costly and potentially toxic systemic agents may be avoidable.