Dermo-cosmetic spray containing Rhealba oat plantlets and Uncaria tomentosa extract in patients with mild-to-moderate cutaneous pain.

BACKGROUND: Chronic cutaneous pain has a substantial negative impact on quality of life (QoL). Dermo-cosmetics can support therapies for treatment of chronic skin diseases, providing symptomatic relief from chronic cutaneous pain and improved QoL. OBJECTIVES: To assess the global tolerance and efficacy of a dermo-cosmetic spray containing Rhealba® Oat Plantlet and Uncaria tomentosa extracts in reducing cutaneous pain when used as a monotherapy or in association with drug or dermo-cosmetic treatments in patients with an underlying skin pathology. METHODS: Patients aged ≥1 month with a cutaneous pain level ≥3 and an underlying skin pathology were provided with the spray to use up to six times daily for 6-8 weeks. Immediate effect on cutaneous pain and patient satisfaction were assessed after the first application. Global efficacy and tolerance, reduction in symptoms, improvement in QoL, pain reduction and patient overall satisfaction were assessed after 6-8 weeks. RESULTS: Immediately after the first application, significant reductions in cutaneous pain were observed across all age groups (P < 0.0001), with 94% of patients reporting a reduction in pain. After 6-8 weeks, global tolerance was rated 'very good' or 'good' for 97% of patients, and the spray was efficacious in 95% of patients. Patient satisfaction with the efficacy of the spray was 95%. QoL scores improved in 86% and 94% of patients aged ≥12 and <12 years, respectively. Findings were similar across underlying pathology and therapy types (monotherapy or in association with another therapy). CONCLUSIONS: The spray was well-tolerated and efficacious in providing symptom relief in patients with mild-to-moderate cutaneous pain, irrespective of the underlying pathology or therapy type.

A multicenter, prospective, observational study examining the impact of risk factors, such as BMI and waist circumference, on quality of life improvement and clinical response in moderate-to-severe plaque-type psoriasis patients treated with infliximab in routine care settings of Greece.

BACKGROUND: Obesity has been associated with moderate-to-severe plaque psoriasis severity and PASI 75 response attainment of biologic therapies, but findings are inconsistent. OBJECTIVE: This study aimed to examine the association of body mass index (BMI) and waist circumference (WC) on disease severity, to identify potential patient characteristics associated with response attainment and to assess the impact of infliximab on the patients' health-related quality of life (HRQoL) among infliximab-treated patients in the routine care setting of Greece. METHODS: This was a multicenter, prospective, observational study of adult moderate-to-severe plaque psoriasis patients who had initiated treatment with originator infliximab within 2 weeks prior to enrolment. Postenrolment visits occurred at 14 ± 4, 30 ± 4 and 54 ± 4 weeks following treatment onset. RESULTS: Between October 2012 and June 2014, 136 eligible patients (62.5% males) with a median age of 48.6 years, BMI of 29.6 kg/m2 and WC of 107.0 cm at enrolment were recruited by 21 dermatology hospital/private offices. All patients had received prior psoriasis treatment(s); 62.5% were biologic-naïve. Mean baseline psoriasis area severity index (PASI) and Dermatology Quality of Life Index (DLQI) scores were 23.4 ± 13.6 and 15.0 ± 8.3, respectively. A low correlation was observed between WC at enrolment and baseline PASI [ρ = 0.324 (P < 0.001)]. Over a median 48.4 weeks of infliximab exposure, 89.3% of the per protocol set achieved a PASI 75 response. At 14, 30 and 54 weeks, the PASI 75 attainment rate was 66.4%, 74.8% and 76.6%, respectively; the clinically meaningful DLQI improvement (≥5 point decrease) rate was 68.9%, 75.7% and 69.8%, respectively. BMI category and abdominal obesity at enrolment did not impact PASI 75 or DLQI improvement rate attainment. CONCLUSION: In the routine care of Greece, infliximab reduced disease activity and improved the quality of life of moderate-to-severe psoriasis patients through 1 year of treatment, independent of their BMI and WC.

Gain or loss? Sunscreen efficiency after cosmetic pretreatment of the skin.

Sunscreens are a key pillar of the multimodal protection strategy against short- and long-term impacts of intermittent and continuous UV exposure. Hitherto, an unanswered part of current scientific discourse is the question whether a cosmetic pretreatment has an impact on distribution and adhesiveness of sunscreens on the skin and therefore affects UV protection. In order to evaluate the homogeneity of sunscreen filter distribution, water resistance as a parameter of adhesiveness and effective UV protection of sunscreens after a pretreatment with cream or lotion was investigated in 18 volunteers who were examined before and after swimming, using the established combination of the tape stripping procedure and UV/VIS spectroscopy. It was shown that a cosmetic skin pretreatment affects neither filter homogeneity nor effective UV protection prior to water contact. However, compared to nonpretreated skin, a considerable loss of water resistance is caused. Therefore, using a cream or lotion before application of sunscreens is not to be recommended.

Methods for the evaluation of the protective efficacy of sunscreen products.

The objective of the present investigation was to examine the utilization of optical and spectroscopic methods for the noninvasive characterization of Anthelios XL Fluide Extreme (SPF 50+), an exemplary sunscreen, concerning its homogeneity of distribution on the skin, its spectroscopic properties and its overall protective efficacy. The homogeneity of the distribution of the sunscreen on the skin was investigated with a multiphoton tomography microscope. Additionally, the sum transmission spectrum was determined using tape stripping and spectroscopic measurements. The results revealed a very homogeneous distribution of the sunscreen on the skin surface and also in the deep furrows. The sum transmission spectrum reflects a high protective efficacy of the sunscreen in both the UVA and UVB ranges. The sunscreen Anthelios XL Fluide Extreme (SPF 50+) generates a comfortable feeling on the skin and can be easily distributed. The presented optical methods have been shown to be suitable to investigate the overall protective efficacy of sunscreen products objectively, noninvasively and quickly.

In vivo investigation of the efficiency of a nanoparticle-emulsion containing polihexanide on the human skin.

Skin antisepsis is a key element for the prevention of surgical site infections, as well as for infections after injection and punctures. Recent investigations have shown that about 25% of the resident bacterial flora of the human skin resides within the hair follicle. These findings strongly suggest that the skin appendages play the role of a bacterial reservoir. The bacteria within the hair follicles therefore may be the cause of endogenous germ repopulation after skin antisepsis, highlighting the need for new antiseptic formulations that can sufficiently penetrate into the hair follicles. Various experiments have found that nano-sized particles as well as oil-in-water emulsions are efficient carriers for substances into the hair follicles. In the present study, we investigated the in vivo antiseptic potential of the particle-associated and aqueous polihexanide on the human skin by monitoring bacterial growth after antisepsis over a period of 2.5h. The experiments suggest that the use of a particle-bound antiseptic can achieve a better and longer lasting antisepsis of the human skin than in non-particulate form.

Quantification of the inhomogeneous distribution of topically applied substances by optical spectroscopy: definition of a factor of inhomogeneity.

The inhomogeneous distribution of topically applied substances due to decisive differences in the skin structure (furrows and wrinkles) affects the efficacy of cosmetic products, in particular sunscreens. The combination of tape stripping and optical spectroscopy results in absorption data, which reflect ex vivo the inhomogeneity of the in vivo distribution of topically applied substances. Based on these data, a factor of inhomogeneity is defined describing the individual distribution of formulations on the skin surface of volunteers. Thus, the influence of different skin surface structures and the influence of different formulations on the distribution of the topically applied substances can be determined. Analyzing the inhomogeneity data on 6 volunteers (5 sunscreens per volunteer), it was found that the influence on the distribution of sunscreens caused by the formulation was higher than the inhomogeneity originating from the differences in the skin surface structure of the volunteers. The method is well suited to characterize, for example, sunscreens and antiaging creams in the process of development, as well as for the evaluation of the final products.

Comparison of transepidermal water loss and laser scanning microscopy measurements to assess their value in the characterization of cutaneous barrier defects.

The exact qualitative and quantitative analysis of wound healing processes is a decisive prerequisite for optimizing wound care and for therapy control. Transepidermal water loss (TEWL) measurements are considered to be the standard procedure for assessing the progress of epidermal wound healing. The damage to the stratum corneum correlates with an increased loss of water through the skin barrier. This method is highly susceptible to failure by environmental factors, in particular by temperature and moisture. This study was aimed at comparing TEWL measurements and in vivo laser scanning microscopy (LSM) for the characterization of the epidermal wound healing process. LSM is a high-resolution in vivo method permitting to analyze the kinetics and dynamics of wound healing at a cellular level. While the TEWL values for the individual volunteers showed a wide scattering, LSM permitted the wound healing process to be clearly characterized at the cellular level. However, a comparison between the two methods was very difficult, because the results provided by LSM were images and not numerical. Therefore, a scoring system was set up which evaluates the stages of wound healing. Thus, the healing process could be numerically described. This method is independent of any environmental factors. Providing morphologically qualitative and numerically quantitative analyses of the wound healing process and being far less vulnerable to failure, LSM is advantageous over TEWL.

In vivo investigations on the penetration of various oils and their influence on the skin barrier.

BACKGROUND: The skin represents a potent barrier to the environment, which can be enhanced by the topical application of skin care products, such as oil and oil-based formulations by moisturizing the skin. METHODS: The aim of this study was the investigation of the penetration behaviour of four vegetable oils and of paraffin oil into the stratum corneum by laser scanning microscopy. In addition, the occlusion capacity of these substances was assessed by transepidermal water loss (TEWL) measurements. Petrolatum served as a positive control for skin occlusion. The study was conducted in vivo and included six healthy volunteers. RESULTS: Paraffin oil, as well as the vegetable oils, penetrated only into the first upper layers of the stratum corneum. TEWL measurements indicated that the application of the vegetable oils (except jojoba oil) as well as paraffin oil, led to a similar occlusion of the skin surface. The most effective occlusion was found for petrolatum. CONCLUSION: For the investigated oils, a deeper penetration than into the first upper layers of the stratum corneum could be excluded. The decreased TEWL values indicate that the application of the oils leads to a semi-occlusion of the skin surface as it is intended by the use of oils to retain moisture in skin.

Association of thyroid autoimmunity with acne in adult women.

BACKGROUND: During the last decades an increase has been observed regarding acne in adults and especially women. OBJECTIVE: To evaluate the association between thyroid disorder and the presence of post-adolescent acne in adult women, comparing with healthy controls. METHODS: 107 adult women with post-adolescent acne and 60 healthy controls were included. Complete blood count and standard biochemical profile of C-Reactive Protein (CRP) and levels of thyroid hormones and antibodies [triiodothyronine (T3), thyroxine (T4), thyroid stimulating hormone (TSH), free T3 (FT3), free T4 (FT4), antithyroglobulin antibodies (anti-TG) and anti-thyroid peroxidase antibodies (anti-TPO)] were determined in all subjects of both the acne and control groups. A thyroid ultrasound was also performed. RESULTS: There was a statistically significant difference (P=0.008) in the prevalence of positive anti-TG antibodies, with 25.2% of the acne group and 8.3% of the control group having elevated (>40 U/mL) anti-TG levels, respectively. Adult women with acne had a statistically significant increased relative risk to have high levels of anti-TG in comparison with healthy controls (odds ratio 3.89, P=0.011). This association was independent of age. Values for TSH, FT4, FT3, T4 and anti-TPO did not significantly differ between the two groups. No significant difference was found regarding the thyroid ultrasound findings. Although there was no significant difference between cases and controls regarding CRP levels, it is interesting that we observed a significant elevation in CRP in those acne patients who had positive antithyroglobulin antibodies. CONCLUSIONS: It is likely that thyroid autoimmunity might be more frequent in the adult acne patients and this should be kept in mind when screening women with post-adolescent acne.

Uptake of antioxidants by natural nutrition and supplementation: pros and cons from the dermatological point of view.

The pros and cons of the systemic and topical application of antioxidant substances are a subject of intense discussion among experts, with resulting confusion for consumers and producers. The objective of the present article is to clarify the various uncertainties relating to the use of antioxidant substances in dermatology. Whereas inappropriate application of antioxidant substances (concerning their concentration and composition) might induce harmful effects, the consumer will definitively benefit from physiological concentrations and compositions of antioxidants. The most suitable method is the consumption of natural antioxidants in the form of fruit and vegetables, for example. In addition, the skin, which also accumulates antioxidant substances, may profit from a sufficient antioxidative level, as damage induced by sun radiation in addition to skin aging is reduced.

Pathways of lateral spreading.

In the case of topically applied substances, usually both lateral spreading and competitive penetration into the skin occur in parallel. In the present study, the pathways of lateral spreading were studied quantitatively and visually. The local distribution and lateral spreading of the UV filter substance butyl methoxydibenzoylmethane applied in an o/w emulsion was studied on the forearm and the back. The tape stripping procedure was used to determine the recovery rates inside and outside the area of application. The skin characteristics of transepidermal water loss, pH value, hydration of the stratum corneum and sebum rate were determined at both anatomic sites. Photography and laser scanning microscopy were used to visually investigate the lateral spreading of topically applied dyes. On the back, a preferred direction of lateral spreading parallel to the body axis was observed. This result was caused by differences in the network of furrows. The furrows functioned as a pathway for lateral spreading, whereas the follicles formed a reservoir for the topically applied substance.

Psoriasis: is it the tip of the iceberg for the quality of life of patients and their families?

OBJECTIVE: To evaluate the impact of psoriasis on patients' and their relatives' quality of life (QoL). METHODS: Eighty patients with their accompanying family members were included in the study. For measuring health related QoL (HRQoL) of patients with psoriasis, two questionnaires were used: Short Form 36 Health Survey (SF-36) and EuroQol (EQ-5D). Disease-specific HRQoL was assessed by the Dermatology Life Quality Index. For measuring the quality of life of patients' relatives, a specific questionnaire for dermatological diseases was used (Family Dermatology Life Quality Index, FDLQI). RESULTS: Of our patients, 88.3% reported that their disease affects in many and different ways their QoL whereas only 11.2% reported that psoriasis does not influence at all their life. Regarding FDLQI, 90% of the participating family members, responded that their relative's psoriasis affected their own QoL. CONCLUSIONS: Psoriasis is a chronic disease that affects in a cumulative way the quality of life of both patients and their close relatives.

Sequential treatment with biologics: switching from efalizumab to etanercept in 35 patients with high-need psoriasis.

BACKGROUND: Use of biological agents has been shown to be an efficacious approach in psoriasis, when traditional treatments fail. However, there are limited data on the effectiveness and safety of switching from one biological agent to another. OBJECTIVES: We aimed to evaluate the effectiveness and safety of etanercept as a sequential treatment in patients previously treated with efalizumab, and to evaluate different transition strategies from efalizumab to etanercept. METHODS: We present a retrospective study in patients with high-need plaque psoriasis who were unable to continue efalizumab and were immediately switched to etanercept. RESULTS: We included 35 patients during a 4.5-year period. At 24 weeks of etanercept therapy, 57% of patients had a PASI reduction of 75%, suggesting that alternating between biological agents is feasible. We used three different switching approaches: (i) etanercept in combination with cyclosporine as bridge therapy, (ii) etanercept in combination with methotrexate as bridge therapy, (iii) etanercept monotherapy. Combination therapy was efficacious in all patients, including eight patients with rebound phenomenon with efalizumab. Etanercept was discontinued in two patients as a result of serious adverse events that consisted of an oral squamous cell carcinoma and a diffuse B-cell-non-Hodgkin lymphoma. CONCLUSIONS: In our experience, it seems that etanercept alone may not be sufficient when transitioning from efalizumab in high-need patients with severe worsening or rebound of psoriasis. In such patients, combination of etanercept with cyclosporine or methotrexate is a more effective approach. Non-response to efalizumab did not preclude clinical response after switching to etanercept.

Infliximab for the treatment of psoriasis in Greece: 4 years of clinical experience at a single centre.

BACKGROUND: Infliximab, a chimeric monoclonal antibody, has been shown to be effective for moderate to severe psoriasis. Clinical experience with long-term infliximab therapy for psoriasis is accumulating, and it is therefore important to share our experience with its use in real-life clinical practice. OBJECTIVES: To report our experience with infliximab (Remicade; Schering Plough, Kenilworth, NJ, U.S.A.) for the treatment of moderate to severe plaque psoriasis (and/or arthritis) from a single clinic in Greece. PATIENTS AND METHODS: Between August 2004 and March 2008, 62 patients presenting to our clinic with moderate to severe psoriasis were treated with infliximab. Disease phenotype, clinical course, disease severity and adverse events were assessed throughout the treatment period. RESULTS: Infliximab resulted in a reduction of median Psoriasis Area and Severity Index (PASI) of 70% at week 6 and 84.4% at week 14. Nineteen patients who have completed 1 year on infliximab treatment experienced sustained efficacy with a median PASI improvement of 92.16% and a Physician's Global Assessment (PGA) of 'clear' or 'almost clear', while nine patients have reached approximately 20 months of continuous therapy. All patients with psoriatic arthritis showed marked improvement in their clinical symptoms following the first infusion. Eight patients (12.9%) experienced adverse events that required discontinuation of treatment. There were no statistically significant differences in PASI and Dermatology Life Quality Index (DLQI) scores between patients with arthritis and those with only skin lesions, or between those who received methotrexate, either from the beginning or during infliximab therapy, and those who did not receive methotrexate at all. Selected patients of interest are discussed. CONCLUSIONS: The above data confirm previous reports that treatment with infliximab is an efficacious and safe option for patients with moderate to severe plaque psoriasis (and/or arthritis). Long-term follow-up, continued pharmacovigilance, and controlled comparative studies will be required to fully evaluate its use in the treatment of psoriasis.