Ruxolitinib Cream Has Dual Efficacy on Pruritus and Inflammation in Experimental Dermatitis.

The goal of this study was to elucidate the anti-pruritic and anti-inflammatory efficacy of ruxolitinib cream in experimentally-induced dermatitis. Atopic dermatitis (AD), the most common chronic relapsing inflammatory skin disease, significantly impairs patients' quality of life, with pruritus being a common complaint. The sensation of itch results from the interplay between epidermal barrier dysfunction, upregulated immune signaling and the activation of the central nervous system. The Janus kinase (JAK)-signal transducer and activator of transcription (STAT) pathway plays a central role in pro-inflammatory cytokine signaling in AD. Ruxolitinib cream is a potent and selective JAK1/2 inhibitor currently undergoing clinical evaluation in adults with mild-to-moderate AD (NCT03745638, NCT03920852 and NCT03745651). The efficacy of ruxolitinib cream was tested in murine models of acute and chronic dermatitis and was also characterized in an ex vivo human skin dermatitis model. Ruxolitinib cream was highly effective at ameliorating disease symptoms in multiple murine dermatitis models through downregulation of T helper (Th)2-driven inflammation, resulting in reduced skin thickening and decreased itch. Pathway analysis of mouse ear tissue and human skin explants underscored the role for ruxolitinib in ameliorating inflammation and reducing itch via modulation of the JAK-STAT pathway. Together, the data offer a strong rationale for the use of ruxolitinib cream as a potent therapeutic agent for the clinical management of atopic dermatitis.

Erythema multiforme like reaction to santos rosewood (Machaerium scleroxylon) and Torreya nucifera.

Erythema multiforme is a skin disorder characterised by target epithelial eruption, which is mainly caused by infection or drugs. In this case, we report an erythema multiforme like reaction caused by contact dermatitis against wood, especially santos rosewood. During the hospitalisation, we performed a patch test with lumber used in the patient's workplace, and recognised a positive response to multiple woods and a simultaneous recurring eruption (flare up) outside of the test site. The findings from this case of contact dermatitis caused by frequently used industrial wood type is important for the management of occupational environments. A review of the literature on erythema multiforme like reaction due to contact dermatitis, including past case reports, has also been provided.

Comparison of effectiveness and safety of excimer lamp vs topical calcipotriol-clobetasol propionate combination in the treatment of palmoplantar psoriasis.

BACKGROUND: Very few studies have assessed the efficacy of excimer in the treatment of palmoplantar psoriasis (PPP), and none has compared the excimer with calcipotriol-clobetasol propionate combination. PURPOSE: To compare the effectiveness and safety of excimer lamp vs topical ointment containing calcipotriol (0.005% w/w) and clobetasol propionate (0.05% w/w) combination in PPP. METHODS: This right-left randomization trial included 36 patients with PPP, who received treatment with excimer lamp (twice weekly) on one side and calcipotriol-clobetasol combination (once daily) on another side for 12 weeks, followed by 8 weeks of follow-up. Recruitment and response assessment was done by 2 experienced dermatologists (SD and TN) using modified palmoplantar pustular psoriasis area and severity index score (mPPPASI, originally devised for palmoplantar pustulosis, suitably modified to assess response in PPP). Primary outcome measure was percentage improvement in mPPPASI at 12 weeks, which was classified as minimal (≤25%), mild (>25%-50%), moderate (>50%-75%), and marked (>75%). Secondary outcome measures were the proportion of patients achieving >75% reduction in mPPPASI and the time taken to achieve it. RESULTS: Of 36 recruited patients, 33 completed treatment and 21 adhered to 8-weeks follow-up. The mean mPPPASI on the excimer-treated sides reduced significantly from 7.75 ± 4.62 to 4.01 ± 4.07 (P < .001) at 12th week (end of the treatment) and 2.66 ± 3.97 at 20th week (at 8 weeks follow-up). The mean mPPPASI on the calcipotriol-clobetasol combination treated sides reduced significantly from 7.36 ± 4.46 to 3.55 ± 3.77 (P < .001) and 2.70 ± 3.97 at 12th week and 20th week, respectively. The reduction was significant for both treatment and the difference between the two was not statistically significant. Minimal, mild, moderate, and marked improvement was seen in 5/33 (15.2%) and 1/33 (3.0%), 6/33 (18.2%) and 8/33 (24.2%), 12/33 (36.4%) and 13/33 (39.4%), and 8/33 (24.2%) and 8/33 (24.2%) sides in the excimer and calcipotriol-clobetasol combination, respectively. A total of 8 patients in each group achieved mPPPASI 75 at 12 weeks. The mPPPASI 75 was achieved at 2, 4, and 8 weeks in 1, 2, and 8 patients, respectively, using either modalities. The adverse effects (most commonly hyperpigmentation) were noted more frequently on the excimer-treated sides; however, they were well tolerated. CONCLUSION: Both excimer lamp and calcipotriol-clobetasol propionate combination are equally effective in the treatment of PPP.

Potential emerging treatment in vitiligo using Er:YAG in combination with 5FU and clobetasol.

BACKGROUND: Vitiligo is a pigmentary disorder of skin affecting at least 1% of the world population of all races in both sexes. Its importance is mainly due to subsequent social and psychological problems rather than clinical complications. Various treatment choices are available for vitiligo; however, laser-based courses have shown to give more acceptable results. OBJECTIVE: The aim of this trial was to evaluate the efficacy of Er:YAG laser as a supplementary medicine to topical 5FU and clobetasol in vitiligo patients. METHODS: Two comparable vitiligo patches from 38 eligible patients were randomized to receive topical 5FU and clobetasol in control group and additional Er:YAG laser in intervention group. Major outcomes of interest were the size of patch and pigmentation score at randomization and 2 and 4 months after therapy. RESULTS: Final sample included 18 (47%) male patients and age of 35.66±8.04. The performance Er:YAG group was superior in all sites. Reduction in the size of patches was greater in Er:YAG group (p-value=.004). Also, this group showed a higher pigmentation scores in the trial period than control group (p-value<.001). CONCLUSIONS: Greater reduction in the size and increase in pigmentation score was seen in Er:YAG group especially for short periods after therapy and repeating laser sessions may help improving final outcomes. Er:AYG could help in reducing complications of long-term topical treatments, achieving faster response, and improving patient adherence.

In Vivo Assessment of Clobetasol Propionate-Loaded Lecithin-Chitosan Nanoparticles for Skin Delivery.

The aim of this work was to assess in vivo the anti-inflammatory efficacy and tolerability of clobetasol propionate (CP) loaded lecithin/chitosan nanoparticles incorporated into chitosan gel for topical application (CP 0.005%). As a comparison, a commercial cream (CP 0.05% w/w), and a sodium deoxycholate gel (CP 0.05% w/w) were also evaluated. Lecithin/chitosan nanoparticles were prepared by self-assembling of the components obtained by direct injection of soybean lecithin alcoholic solution containing CP into chitosan aqueous solution. Nanoparticles obtained had a particle size around 250 nm, narrow distribution (polydispersity index below 0.2) and positive surface charge, provided by a superficial layer of the cationic polymer. The nanoparticle suspension was then loaded into a chitosan gel, to obtain a final CP concentration of 0.005%. The anti-inflammatory activity was evaluated using carrageenan-induced hind paw edema test on Wistar rats, the effect of formulations on the barrier property of the stratum corneum were determined using transepidermal water loss measurements (TEWL) and histological analysis was performed to evaluate the possible presence of morphological changes. The results obtained indicate that nanoparticle-in-gel formulation produced significantly higher edema inhibition compared to other formulations tested, although it contained ten times less CP. TEWL measurements also revealed that all formulations have no significant disturbance on the barrier function of skin. Furthermore, histological analysis of rat abdominal skin did not show morphological tissue changes nor cell infiltration signs after application of the formulations. Taken together, the present data show that the use of lecithin/chitosan nanoparticles in chitosan gel as a drug carrier significantly improves the risk-benefit ratio as compared with sodium-deoxycholate gel and commercial cream formulations of CP.

A comparative study of combined treatment with fractional carbon dioxide and targeted ultraviolet B phototherapy for facial vitiligo.

Facial vitiligo is associated with considerable psychological impact. The management is challenging and requires multidisciplinary treatment. Adding fractional carbon dioxide (CO2) to the conventional treatment has been reported as an effective modality. This study aimed to evaluate the efficacy of combined fractional CO2 laser, targeted ultraviolet B (UVB) phototherapy, and topical steroid on facial vitiligo. A prospective, randomized, split face study was conducted on 14 patients with symmetrical non-segmental facial vitiligo. Ten sessions of fractional CO2 laser was performed on the lesions on one side of face with 2-week interval. Immediately after laser, the lesions on both side of face were treated with 10 sessions of 2-week interval targeted UVB phototherapy and twice daily application of topical 0.05 % clobetasol propionate cream. The patients were followed up for 12 weeks after the last treatment. Clinical improvement was graded by blinded dermatologists and patients using a quartile grading scale. Twelve out of 14 patients completed the study. The degree of improvement was not different between both sides in nine patients. One patient showed more improvement on the combined laser side, and two patients showed inferior results on the combined laser side. Two patients with lesser improvement on the laser-treated side had positive Koebner phenomenon on the non-facial area. The combined treatment with laser, targeted UVB, and topical steroids are not superior to targeted UVB and topical steroids in facial vitiligo. Furthermore, laser may retard the response to the standard treatment in patients with Koebner phenomenon on non-treated areas.

An open label pilot study of supraerythemogenic excimer laser in combination with clobetasol spray and calcitriol ointment for the treatment of generalized plaque psoriasis.

A common therapeutic modality for psoriasis includes the combination of phototherapy with topical treatments. The recent development of targeted phototherapy with the excimer laser and spray formulations for topical treatments has increased the efficacy and convenience of these combinational therapies. Herein, we aim to assess the efficacy of a novel combination of therapies using the 308 nm excimer laser, clobetasol propionate spray and calcitriol ointment for the treatment of moderate to severe generalized psoriasis. In this 12-week study, patients with moderate to severe psoriasis received twice weekly treatments with a 308-nm excimer laser combined with clobetasol proprionate twice daily for a month followed by calcitriol ointment twice daily for the next month. Of the 30 patients enrolled, 83% of patients (25/30) achieved PASI-75 [65-94%, 95% confidence interval (CI)] at week 12. For PGA, there was an estimated decrease of 3.6 points (3.1-4.1, 95% CI, p < 0.0005) by week 12. In conclusion, the combination of excimer laser with alternating clobetasol and calcitriol application has shown to be a promising combination of therapies for the treatment of moderate to severe generalized psoriasis. Further evaluation may be conducted with a larger study inclusive of control groups and head-to-head comparisons against topical steroid and UVB therapy as monotherapies.

Epigenetic Modifications and Accumulation of DNA Double-Strand Breaks in Oral Lichen Planus Lesions Presenting Poor Response to Therapy.

Epigenetics refers to changes in cell characteristics that occur independently of modifications to the deoxyribonucleic acid (DNA) sequence. Alterations mediated by epigenetic mechanisms are important factors in cancer progression. Although an exciting prospect, the identification of early epigenetic markers associated with clinical outcome in premalignant and malignant disorders remains elusive. We examined alterations in chromatin acetylation in oral lichen planus (OLP) with distinct clinical behavior and compared the alterations to the levels of DNA double-strand breaks (DSBs). We analyzed 42 OLP patients, who had different responses to therapy, for acetyl-histone H3 at lys9 (H3K9ac), which is associated with enhanced transcription and nuclear decondensation, and the presence of DSBs, as determined by accumulation of phosphorylated γH2AX foci. Patients with high levels of H3K9ac acetylation failed to respond to therapy or experienced disease recurrence shortly after therapy. Similar to H3K9ac, patients who responded poorly to therapy had increased accumulation of DNA DSB, indicating genomic instability. These findings suggest that histone modifications occur in OLP, and H3K9ac and γH2AX histones may serve as epigenetic markers for OLP recurrence.

Supraerythemogenic excimer laser in combination with clobetasol spray and calcitriol ointment for the treatment of generalized plaque psoriasis: Interim results of an open label pilot study.

BACKGROUND: The combination of phototherapy and topical therapy is one of the most widely used treatment modalities for moderate to severe psoriasis. The development of targeted phototherapy with excimer laser and new topical spray formulations has made these therapies both more convenient and more effective. In this open label pilot study, we aim to assess the efficacy of combination therapy using 308-nm excimer laser, clobetasol propionate spray and calcitriol ointment for the treatment of moderate to severe generalized psoriasis. METHODS: In this 12-week study, patients with moderate to severe psoriasis received twice weekly treatment with XTRAC® Velocity 308-nm excimer laser combined with clobetasol propionate twice daily followed by calitriol ointment twice daily. RESULTS: To date, 21 patients have completed the protocol. By week 12, 76% of the patients had a reduction in Psoriasis Area and Severity Index by at least 75% (PASI-75) and 52% had a Physicians Global Assessment of "clear" or "almost clear". CONCLUSIONS: Excimer laser therapy combined with an optimized topical regimen that includes clobetasol spray followed by calictriol ointment appears to be an effective treatment for moderate to severe generalized psoriasis that avoids the risk of serious internal side effects associated with many systemic agents.

Efficacy of laser phototherapy in comparison to topical clobetasol for the treatment of oral lichen planus: a randomized controlled trial.

Oral lichen planus (OLP) is a relatively common chronic mucocutaneous inflammatory disease and a search for novel therapeutic options has been performed. We sought to compare the efficacy of laser phototherapy (LPT) to topical clobetasol propionate 0.05% for the treatment of atrophic and erosive OLP. Forty-two patients with atrophic/erosive OLP were randomly allocated to two groups: clobetasol group (n=21): application of topical clobetasol propionate gel (0.05%) three times a day; LPT group (n=21): application of laser irradiation using InGaAlP diode laser three times a week. Evaluations were performed once a week during treatment (Days 7, 14, 21, and 30) and in four weeks (Day 60) and eight weeks (Day 90) after treatment. At the end of treatment (Day 30), significant reductions in all variables were found in both groups. The LPT group had a higher percentage of complete lesion resolution. At follow-up periods (Days 60 and 90), the LPT group maintained the clinical pattern seen at Day 30, with no recurrence of the lesions, whereas the clobetasol group exhibited worsening for all variables analyzed. These findings suggest that the LPT proved more effective than topical clobetasol 0.05% for the treatment of OLP.

UV-A1 phototherapy vs clobetasol propionate, 0.05%, in the treatment of vulvar lichen sclerosus: a randomized clinical trial.

IMPORTANCE: Topical corticosteroids are the current first-line therapy for vulvar lichen sclerosus (VLS). UV-A1 phototherapy may be a promising alternative treatment option, but controlled studies are lacking. OBJECTIVE: To compare the efficacy of high-potent topical corticosteroids with UV-A1 phototherapy in the treatment of VLS. DESIGN, SETTING, AND PARTICIPANTS: A 2-arm randomized clinical trial was conducted at a university hospital dermatology department according to the intention-to-treat principle with last observation carried forward. The study population comprised 30 female patients with VLS. INTERVENTIONS: Treatment of VLS with clobetasol propionate, 0.05%, ointment applied once daily for 3 months or medium-dose UV-A1 (50 J/cm²) home-based phototherapy, performed 4 times weekly for 3 months. MAIN OUTCOMES AND MEASURES: Mean relative reduction of the total clinician's score (TCS) was considered the primary outcome measure. Secondary outcome measures included the reduction of pruritus and burning and/or pain according to a visual analog scale (VAS), a health-related quality of life score (Skindex-29), 20-MHz ultrasonography, and histopathological analysis before and after 3 months of therapy. RESULTS: Fifteen patients were randomized in each treatment arm, and 2 patients dropped out in both treatment arms. After therapy, both therapies resulted in a significant decrease in mean TCS (51.4% [95% CI, 39.7% to 63.0%] for clobetasol ointment [P < .001] and 35.6% [95% CI, 18.2% to 53.1%] for UV-A1 phototherapy [P = .006]). No significant difference was found between both treatments (P > .05). The Skindex-29 (mean difference [MD], 29.6 [95% CI, 7.9 to 51.2] [P = .009]) and the VAS score for pruritus (MD, 4.6 [95% CI, 1.5 to 7.7] [P = .005]) and burning and/or pain (MD, 4.2 [95% CI, 1.9 to 6.6] [P = .001]) significantly decreased after clobetasol treatment. After UV-A1 phototherapy, the VAS score for burning and/or pain (MD, 3.2 [95% CI, 0.7 to 5.7] [P = .01]) was also significantly reduced; however, there was no significant reduction in pruritus (MD, 2.1 [95% CI, 0.5 to 3.7] [P = .16]) and in the Skindex-29 score (MD, 4.9 [95% CI, -12.6 to 22.4] [P > .99]). A significant reduction of the corium thickness and a significant increase in dermal density in 20-MHz ultrasonography as well as significant histopathological reduction of the inflammatory infiltrate was observed after clobetasol treatment but not after UV-A1 phototherapy. CONCLUSIONS AND RELEVANCE: Although resulting in a significant clinical improvement, UV-A1 phototherapy was inferior to the current gold standard treatment with topical high-potent corticosteroids with respect to practicability, relief of itch, and improvement in quality of life. UV-A1 phototherapy may be considered a potential second-line treatment for VLS. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01400022.

Influence of the type of vegetable oil on the drug release profile from lipid-core nanocapsules and in vivo genotoxicity study.

The use of rice bran (RB), soybean (SB) or sunflower seed (SF) oils to prepare lipid-core nanocapsules (LNCs) as controlled drug delivery systems was investigated. LNCs were prepared by interfacial deposition using the preformed polymer method. All formulations showed negative zeta potential and adequate nanotechnological characteristics (particle size 220-230 nm, polydispersity index < 0.20). The environmental safety was evaluated through an in vivo protocol (Allium cepa test) and LNCs containing RB, SB or SF oils did not present genotoxic potential. Clobetasol propionate (CP) was selected as a model drug to evaluate the influence of the type of vegetable oil on the control of the drug release from LNCs. Biphasic drug release profiles were observed for all formulations. After 168 h, the concentration of drug released from the formulation containing SF oil was lower (0.36 mg/mL) than from formulations containing SB (0.40 mg/mL) or RB oil (0.45 mg/mL). Good correlations between the consistency indices for the LNC cores and the burst and sustained drug release rate constants were obtained. Therefore, the type of the vegetal oil was shown as an important factor governing the control of drug release from LNCs.

Imiquimod therapy for extramammary Paget's disease of the vulva: a viable non-surgical alternative.

Extramammary Paget's disease (EMPD) is a rare intraepidermal adenocarcinoma that can affect the vulval skin. Surgical excision is the gold-standard treatment, however, recurrence rates are high and extensive excisions can produce long-lasting cosmetic and functional defects. We describe one of the largest case series to-date (n = 6) on the use of topical 5% imiquimod cream as a novel treatment option and discuss our experiences. With the addition of our six cases to the literature, there are now 29 documented cases of vulval EMPD treated with 5% imiquimod cream. Of these, 50% of primary disease cases and 73% of recurrent primary disease cases have achieved clinical resolution with 5% imiquimod therapy alone. These findings suggest that imiquimod provides a viable alternative to surgical excision for vulval EMPD. However, we acknowledge that this is a simple retrospective analysis and that treatment scheduling and follow-up needs investigation in a trial setting.

Clinical efficacy of a novel topical formulation for vitiligo: compared evaluation of different treatment modalities in 149 patients.

Current vitiligo treatments are not always satisfactory for both patients and dermatologists. Recently, combination therapies have been introduced in order to obtain better results and reduce risks in the management of the disease. Novel efficacious products are needed to improve the therapeutic possibilities of dermatologists in the respect of safety for the patients. The objective of the present study was to evaluate the effects of a novel topical in a gel formulation containing phenylalanine, cucumis melo extract, and acetyl cysteine in vitiligo. The present study used an open observational study to evaluate the efficacy and safety of the investigated product, given alone or in combination with 311-nm narrow band microphototherapy. Results were compared with those obtained treating a matched patient population with microphototherapy alone and with clobetasol propionate 0.05% ointment alone. One hundred forty-nine patients suffering from symmetrical vitiligo affecting less than 10% of the skin surface were evaluated. Patients affected by acral vitiligo only were excluded from the analysis. Treatment duration was scheduled for 12 weeks. Excellent repigmentation (>75%) was achieved by 38-73% of patients, depending on the treatment regimen. Mild to moderate side effects were observed only in patients treated with clobetasol 0.05% ointment. The tested gel formulation showed a good efficacy in improving vitiligo repigmentation. No side effects were observed.

Treatment of psoriasis and long-term maintenance using 308 nm excimer laser, clobetasol spray, and calcitriol ointment: a case series.

Psoriasis is a chronic inflammatory skin disease that is characterized by thickened red plaques covered with silvery scales. Excimer laser therapy is a cutting-edge advancement in UVB phototherapy. In contrast to traditional phototherapy, the 308 nm excimer laser only targets psoriasis plaques, while it spares uninvolved skin. It allows for treatment with a supra-erythmogenic dose of UVB irradiation. Targeted UVB therapy is a possible treatment especially for many who have failed topical treatments, systemic therapy, and traditional phototherapy. For safe and effective psoriasis treatment, a combination of therapies may be used, including a combination of laser treatment with topical medications. We present two cases demonstrating effective treatment with excimer laser in conjunction with clobetasol spray and calcitriol ointment for 12 weeks. Long-term near-clearance of psoriasis was sustained after 6 months and one-year follow up periods without further therapy.

Excimer laser therapy for hairline psoriasis: a useful addition to the scalp psoriasis treatment algorithm.

Psoriasis is a chronic, inflammatory skin condition with negative impacts both physical and psychological. Scalp psoriasis, especially around the hairline, can cause significant impairment in quality of life due to its visibility. Options for treatment of facial psoriasis, including hairline involvement, are the use of low potency topical steroids, calcineurin inhibitors, and vitamin D analogues. Though the use of excimer laser for scalp psoriasis has been reported, there are no cases or studies specifically examining excimer laser phototherapy for the treatment of hairline psoriasis. We present a case of rapid improvement of hairline psoriasis using a regimen of 308 nm excimer laser with clobetasol spray and recommend an algorithm for the optimal treatment of scalp psoriasis utilizing currently available antipsoriatic therapies.

Fixed-drug eruption caused by ashwagandha (Withania somnifera): a widely used Ayurvedic drug.

A 28-year-old man with decreased libido received ashwagandha in the usual daily dosage of 5 g for 10 days. During this period, he experienced a burning and/or itching sensation as well as discoloration of the skin/mucous membrane confined to the penis. He had a similar type of eruption at the same site 6 months prior while taking ashwagandha. Examination of the skin surface was conspicuous and marked by the presence of a dusky, erythematous, oval, eroded plaque of 3 cm, affecting the glans penis and prepuce (Figure). The drug was withdrawn and topical 0.05% clobetasol propionate cream was administered along with cetrizine dihydrochloride, an H1-receptor blocker, 10 mg daily for 1 month. There was a perceptible amelioration of the lesion, resulting in residual greyish white pigmentation. He was prescribed oral drug provocation with 1 g of ashwagandha powder. Within 12 hours, a flare-up developed at the earlier site, confirming the causality.

Clobetasol para o tratamento da psoríase / Clobetasol for the treatment of psoriasis

A DOENÇA: A psoríase é uma doença sistêmica inflamatória crônica, não contagiosa, que afeta principalmente a pele, as unhas e ocasionalmente as articulações. Costuma ter um curso recidivante sendo desencadeada pelo frio, fármacos, infecções e estresse e afeta cerca de 2% da população mundial. Pode ser incapacitante tanto pelas lesões cutâneas - fator importante de dificuldade de inserção social ­ quanto pela presença da forma articular que configura a artrite psoriásica. A psoríase tem sido classificada como doença autoimune, embora sua fisiopatologia não esteja completamente esclarecida. O papel de mecanismos imunes é documentado pela presença de linfócitos T ativados e macrófagos e pela boa resposta a terapias imunossupressoras. A presença de mediadores inflamatórios também foi observada: citoquinas, fator de necrose tumoral , interferon , endotelina-1, eicosanóides, entre outros. Há uma série de comorbidades associadas à psoríase, entre elas alcoolismo, depressão, obesidade, diabete melito, hipertensão arterial, síndrome plurimetabólica, colite e artrite reumatóide. . Há estudos que relatam aumento de mortalidade por doença cardiovascular em pacientes com psoríase. Estes dados indiretos sugerem que a psoríase não está limitada à pele e que por ser uma doença crônica imuno-mediada, o aumento na morbimortalidade associado à doença possa ser explicado por um mecanismo inflamatório multissistêmico. A TECNOLOGIA: Clobetasol - Como os demais corticosteróides, o propionato de clobetasol apresenta propriedades antiinflamatória, antipruriginosa, vasoconstritora e imunossupressora. O mecanismo da atividade antiinflamatória dos esteróides tópicos em geral não está esclarecido. Contudo, acredita-se que os corticosteróides atuem induzindo a síntese da lipocortina. A lipocortina é uma proteína inibidora da atividade da fosfolipase, enzima responsável pela liberação do ácido aracdônico da membrana celular. Uma vez liberado, o ácido aracdônico é metabolizado, produzindo mediadores inflamatórios potentes, tais como prostaglandinas e leucotrienos. O propionato de clobetasol é um corticosteróide que apresenta os efeitos farmacológicos sistêmicos, tópicos e metabólicos característicos desta classe de medicamentos, sendo considerado de muito alta potência. EVIDÊNCIA CIENTÍFICA: Na base de dados Medline/Pubmed foram utilizados os termos "Psoriasis"[Mesh] AND "Therapeutics"[Mesh]. Esta busca foi restrita para estudos em humanos e do tipo metanálise, resultando em 20 artigos. Os estudos identificados nestas buscas foram avaliados individualmente, tendo sido selecionados aqueles com medicamentos tópicos disponíveis no País e com desfechos clínicos de eficácia e segurança, excluindo desfechos laboratoriais/intermediários. Desses, foram selecionadas 5 meta-análises. As exclusões ocorreram pelos seguintes motivos: um artigo em idioma alemão, dois artigos que tratavam de outras dermatoses que não psoríase e os demais por tratarem de tratamento sistêmico ou fototerapia. Foi também realizada a mesma busca, porém tendo como limite somente estudos do tipo ensaio clínico randomizado e publicados nos últimos 2 anos, período não compreendido pelas meta-análises selecionadas, resultando em 53 estudos. Desses foram excluídos 46 artigos: 21 por se tratarem de procedimentos, fármacos ou apresentações não disponíveis no Brasil, 14 por compreenderem tratamento sistêmico ou fototerapia, 6 por técnicas ou tratamentos alternativos, 2 por contemplarem doenças outras que não psoríase, 1 por abordar tema não relevante para a análise e 2 por apresentar delineamento confuso e desfechos não objetivos ou histopatológicos, restando então 7 estudos que foram analisados. A busca na Cochrane Database foi realizada com os termos "Psoriasis" and "Topical Treatment" e originou 3 revisões, 2 foram excluídas por se tratarem de outras formas de psoríase específicas (gutatta e pustulose palmo-plantar). Foi incluída uma revisão da Cochrane Database. DELIBERAÇÃO FINAL: Os membros da CONITEC presentes na 6ª reunião ordinária do dia 05/07/2012, por unanimidade, ratificaram a deliberação de recomendar a incorporação do medicamento clobetasol 0,05% creme conforme Protocolo Clínico e Diretrizes Terapêuticas do Ministério da Saúde para o tratamento da Psoríase. O Conselho Nacional de Saúde se absteve de votar conforme posição acordada pelo Plenário do CNS. DECISÃO: PORTARIA SCTIE/MS N° 33, de 27 de setembro de 2012 - Torna pública a decisão de incorporar o medicamento Clobetasol para o tratamento da Psoríase no Sistema Único de Saúde (SUS).

Dermasilk briefs in vulvar lichen sclerosus: an adjuvant tool.

OBJECTIVE: : The purpose of our study was to evaluate whether briefs made of Dermasilk fabric could be an adjuvant tool in the management of vulvar lichen sclerosus (LS). MATERIALS AND METHODS: : A controlled, randomized, double-blind study versus placebo was conducted, comparing Dermasilk versus standard cotton briefs in patients affected by LS during treatment with clobetasol propionate 0.05% ointment and vitamin E moisturizer. For each patient, an evaluation of objective genital signs and subjective symptoms typical of LS was recorded before the start of treatment, after 1 month, and after 6 months of the study. Statistical analysis was performed with SPSS 17.0 for Windows. RESULTS: : Forty-two women affected by LS were recruited and divided into those wearing Dermasilk or cotton briefs. Patients wearing Dermasilk briefs showed a better improvement in the clinical symptoms of burning sensation, skin irritation, and pain (Fisher test, p < .0001) compared with the cotton placebo group. The improvement in itching was also faster in the Dermasilk group (Fisher exact test, p < .05). Erythema also showed a better improvement in the Dermasilk group (Fisher test, p < 0.05). CONCLUSIONS: : Dermasilk fabric seems to be a useful adjunct to topical treatment in producing a better and more rapid control of symptoms in patients with LS.

Comparison of clobetasol propionate cream plus coal tar vs. topical psoralen and solar ultraviolet A therapy in palmoplantar psoriasis.

AIM: Palmoplantar psoriasis (PPP) produces significant morbidity and requires prompt treatment. Topical agents form the mainstay of therapy. We compared the efficacy and side-effect profile of a steroid/coal-tar combination with topical psoralen and solar ultraviolet A (PUVAsol) in PPP. METHODS: In total, 52 patients with PPP were randomized to receive either a combination of clobetasol propionate cream and coal tar daily (group 1) or topical PUVAsol on alternate days (group 2) for 16 weeks. Response was assessed as change in Psoriasis Activity and Severity Index (PASI) and Patient Global Assessment (PGA). RESULTS: Of the 52 patients, 43 completed the treatment phase. There was a reduction in PASI for the palms and soles in both treatment groups throughout the treatment period until week 16. There was a greater reduction in PASI in palmar psoriasis with topical PUVAsol, and a greater reduction in psoriasis of the soles with the steroid/coal-tar combination. In both groups, patients perceived 'good improvement'. Improvement or cure in palmar lesions was observed in 90% of cases in the topical steroid/coal-tar group and in 75% of cases in the topical PUVAsol group; for the soles, these figures were 76% and 79%, respectively. No adverse effects were experienced with the steroid/coal-tar combination, whereas for the topical PUVAsol, phototoxicity occurred in 22% of cases. CONCLUSION: Both treatments had comparable efficacy. In both groups, patients experienced 'good improvement' after 16 weeks of therapy.