Mometasone Cream Research Articles

Unlocking milk thistle’s anti-psoriatic potential in mice: Targeting PI3K/AKT/mTOR and KEAP1/NRF2/NF-κB pathways to modulate inflammation and oxidative stress

Silybum marianum, known as milk thistle (MT), is traditionally used to manage liver diseases. This study aimed to investigate the role of MT extract topical application as a potential treatment for imiquimod (IMQ)-induced psoriatic lesions in mice with particular emphasis on phosphoinositol-3 Kinase (PI3K)/ protein kinase B (AKT)/ mammalian target of rapamycin (mTOR) and Kelch-like ECH-associated protein 1 (KEAP1)/ nuclear factor erythroid-2-related factor (NRF2)/ nuclear factor-kappa B (NF-κB) molecular cascades involvement. To address this aim, forty male Swiss albino mice were subdivided into four groups (n = 10 mice/group): control, IMQ model, standard group where mice were treated topically with IMQ, then the anti-psoriatic mometasone cream, and MT extract-treated group where mice were treated topically with IMQ followed by MT extract. In most measured parameters, MT extract, rich in silymarin, exhibited potent anti-psoriatic activity comparable to the standard cortisone treatment. MT extract mitigated dorsal skin erythema, scaling, and epidermal thickening, reflected by lowering the Psoriasis Area Severity Index (PASI) score. Moreover, it alleviated IMQ-induced splenomegaly. Mechanistically, the PI3K/AKT/mTOR pathway was the main functional pathway behind such improvements, where it was significantly inhibited by MT extract application. This led to NRF2 activation via KEAP1 downregulation with subsequent anti-inflammatory effect proven by reducing NF-κB, interleukin (IL)–23, and IL-17A and antioxidant ability proven by boosting the antioxidant glutathione and heme oxygenase-1. Such improvements were confirmed by alleviating the histopathological alteration. Thus, MT extract could be a promising therapeutic agent for psoriasis treatment by inhibiting PI3K/AKT/mTOR cascade, along with NRF2 signaling activation.

A Case of a 50-Year-Old Female with Dermatomyositis Secondary to a Paraneoplasm (Infiltrating Ductal Carcinoma, Grade 2)

Introduction: Dermatomyositis is an autoimmune disorder with an incidence of 5 to 10 per 1 million per year. 10 to 20% of patients with adult-onset Dermatomyositis have an underlying malignancy. There are currently no specific cutaneous markers for Paraneoplastic Dermatomyositis. This case highlights a patient with uncommon features of paraneoplasm after breast malignancy. Case Report: A 50-year-old female with Infiltrating Ductal Carcinoma, presented with patches on the face, neck, chest, upper back, outer arms, dorsal hands, thighs, hair loss and weakness. Histopathology revealed widened basal layer vacuolization with widened spaces between collagen bundles filled with mucin deposition, and pigment incontinence in the papillary dermis. Direct immunofluorescence showed granular deposits of IgG, C3, IgM and IgA in the basement membrane zone, which are consistent with Dermatomyositis. The patient was prescribed with Clobetasol ointment mixed equally with petrolatum on the body and Mometasone cream on the face. She was subsequently started on Prednisone at 0.5 mkd with eventual tapering, Omeprazole, and Calcium + Vitamin D tablet daily. Hydroxychloroquine 200 mg/tab daily was added. Referral to Rheumatology for co-management and Surgery for management of the breast mass was also done. Conclusion: This case emphasizes the rare occurrence of a Paraneoplastic Dermatomyositis following a diagnosis of breast malignancy. A careful review upon diagnosis may detect occult malignancies especially in patients who present primarily with cutaneous Dermatomyositis. Clinicopathologic correlation and a multi-disciplinary approach, with Surgery, Oncology, Rheumatology and Dermatopathology are needed to identify the underlying cause and facilitate successful treatment of a neoplasm followed by improvement of Dermatomyositis.

Study of effect of topical mometasone with intralesional platelet-rich plasma versus topical mometasone alone in the treatment of alopecia areata

Background: Alopecia areata (AA) is an autoimmune disorder and exhibits non scarring alopecia. Currently, there is no definitive cure, platelet rich plasma (PRP) has emerged as a newer modality for non-cicatricial alopecias such as AA. This study was conducted to compare the efficacy and adverse effects of topical mometasone with PRP versus topical mometasone alone in the treatment of patients of AA. Methods: This study was conducted on a total of 100 clinically diagnosed cases of AA. Patients in group A were subjected to intradermal injection of autologous PRP every 3 weeks along with topical mometasone cream 0.1% daily for 12 weeks. Group B was treated with topical mometasone cream 0.1% once a day locally over affected site for 12 weeks. Results: Baseline SALT score of group A was 6.05±5.36 while that of group B was 6.62±4.39. The mean SALT score of group A declined to 0.94±1.69 and that of group B 2.19±1.76 over a period of 20 weeks. Excellent response was observed by 12 and 5 patients of group A and group B respectively. Minor side effects like pain was seen in 10 patients (20%) in group A, while atrophy was seen in 2 patients of group B. Conclusions: This is the first ever study evaluating the additional benefit of intralesional PRP. In this study, it was found that adding intralesional PRP with topical mometasone 0.1% cream has higher efficacy and early improvement than topical mometasone alone, in the treatment of AA.

GC-MS analysis and the effect of topical application of essential oils of Pinus canariensis C.Sm., Cupressus lusitanica Mill. and Cupressus arizonica Greene aerial parts in Imiquimod–Induced Psoriasis in Mice

Ethnopharmacological relevanceTraditionally, Coniferous plants, in particular Pinus and Cupressus species, have been used in the treatment of burns, skin infections, and immune-mediated inflammatory diseases such as psoriasis. Aim of the studyA comparative study between essential oils (EOs) extracted from aerial parts of three coniferous plants: Pinus canariensis C.Sm. (PC), Cupressus lusitanica Mill. (CL) and Cupressus arizonica Greene (CA), cultivated in Egypt, was designed to investigate their composition and their anti-psoriasis mechanism. Materials and methodsThe phytochemical profiles were confirmed using Gas Chromatography–Mass Spectrometry (GC-MS) method. In-vivo Imiquimod (IMQ)-induced psoriasis model was performed and EOs were applied topically and compared to mometasone cream as a standard subsequently histopathological analysis and inflammatory biomarkers were measured. ResultsIn GC-MS analysis, Monoterpene hydrocarbons, sesquiterpene hydrocarbons and oxygenated monoterpenes were the major detected classes in the three plants, except in Pinus canariensis essential oil, oxygenated monoterpenes were absent. A significant attenuation of imiquimod-induced psoriasis symptoms after topical application of P. canariensis C.Sm., and C. lusitanica Mill. essential oils were observed by reducing the psoriasis area severity index (PASI) score, alleviating histopathological alteration, restoring the spleen index, and decreasing serum levels of interleukins 23 and 17A. Indeed, the results of Pinus canariensis essential oil is comparable to mometasone and showed no significant difference from standard treatment. On the other hand, the topical application of C. arizonica essential oil failed to alleviate imiquimod-induced psoriasis symptoms as observed in the PSAI score, the histopathological investigation, and the spleen index. ConclusionThe essential oils of P. canariensis C.Sm., and C. lusitanica Mill aerial parts could be promising candidates for psoriasis treatment and for further studies on inflammation-related skin diseases.

Changes in mononuclear cell subsets in capillary and venous blood of patients with psoriasis depending on the treatment

Topical glucocorticoids are conventionally used to treat psoriasis, but such treatment provides a short-term effect, and may cause various complications during long-term usage. A detailed study of the immunopathogenesis of psoriasis has made it possible to use bioengineered drugs that block the main cytokines. It has been shown that IL-36 plays an important regulatory role in pathogenesis of psoriasis. The aim of the study was to study therapeutic effect of patients with psoriasis using topical glucocorticoid hormone versus IL- 36 receptor antagonist (RAIL-36), with respect to clinical course of psoriasis and the subsets of mononuclear cells in venous and capillary blood taken close to the focus of inflammation. 16 patients with psoriasis (group 1a) received 0.1% mometasone cream for 14 days; 20 patients of group 1b received a gel containing 0.4% recombinant RAIL-36 for 14 days. Control group included 20 healthy adults. Treatment efficacy was assessed by PASI, DISHS and DLQI indices. 19 lymphocyte subsets and 3 monocyte subsets were assessed by four-color staining of whole capillary and venous blood with erythrocyte lysis using BD Biosciences (USA) technologies and reagents. It was shown that both drugs led to a decrease in the severity of the disease at the end of treatment. However, 2 weeks after the end of treatment in group 1a, the disease indexes nearly returned to the initial values. Meanwhile, the reduced index levels persisted 2 weeks later in group 1b. Significant deviations (more pronounced in capillary blood) were revealed for the levels of several leukocyte subsets in the psoriasis patients compared with healthy persons. As a result of treatment, we have revealed some changes in the levels of leukocyte subsets common to the two groups, and special differences for the two treatment options, that were more pronounced in capillary blood samples. Both medical preparations used are suitable for treatment of psoriasis.

Labial adhesions: A novel therapeutic approach

Labial adhesion is a common condition found in girls before puberty. All the patients (n = 15) in this series were diagnosed clinically, and routine blood and urine examinations were normal. Mometasone cream was applied topically over the labial adhesions with a positive therapeutic response within 3–8 weeks of treatment. Recurrences of adhesions were found only in two patients who discontinued the treatment after recovery, and repetition of the treatment for 8 weeks solved the issue. Nonsignificant side effects were seen only in two patients. Hence, it can be concluded that mometasone cream is an effective method of treatment for labial adhesions.

A comparative study of efficacy and safety of topical 10% phenylalanine gel versus 0.1% mometasone furoate cream in limited nonsegmental vitiligo

Background: Among various therapeutic options for treating vitiligo, the search for an effective agent to minimize disease progression and achieve repigmentation continues. Topical phenylalanine 10% gel has shown promising results, and hence this study was carried out in patients with limited vitiligo. Aim: To compare the efficacy and safety of topical 10% phenylalanine gel versus topical 0.1% mometasone furoate cream in patients with limited nonsegmental vitiligo. Materials and methods: This study included 74 participants diagnosed as limited nonsegmental vitiligo (≤5 skin lesions). Group A received topical 10% phenylalanine gel (twice daily application), whereas Group B received topical 0.1% mometasone furoate cream (once daily application) for a period of 16 weeks. Clinical improvement based on vitiligo area severity index (VASI) scoring was assessed at intervals of 4 weeks until the end of the study duration. Physician’s global improvement assessment was calculated at the end of the study based on VASI scores. Results: Group A participants showed improvement of 24% when compared with 30.7% in group B at end of 16 weeks. Reduction in VASI scores and clinically visible improvement were noted in both groups after 8 weeks. Adverse events were not noted in any of the groups. Lesions over hands and feet were 11.3 times less likely to show response to treatment when compared with other sites. Conclusion: Both phenylalanine and mometasone were able to achieve significant repigmentation in the participants without any adverse effects. Mometasone achieved marked to excellent response in a higher percentage of participants. The overall efficacy of topical mometasone cream was better than topical phenylalanine gel.

Phosphodiesterase 4 (PDE4) gene expression in atopic dermatitis patients, before and after treatment with topical mometasone cream.

Atopic dermatitis (AD) is a chronic pruritic inflammatory dermatosis. Phosphodiesterases (PDEs) are a superfamily of enzymes that catalyse the hydrolysis of cyclic AMP (cAMP), a second messenger that controls key cellular functions, into its inactive forms. Selective inhibitors of PDE4, a cAMP-specific PDE, serve as potent anti-inflammatory agents. To measure PDE4 gene expression in patients with AD before and after treatment with topical mometasone cream, in comparison to controls Twenty patients with acute and subacute AD were investigated. Skin biopsies before and after treatment were obtained for evaluation of PDE4 expression level by RT-PCR The level of PDE4 mRNA was significantly higher in AD patients either before or after treatment compared to controls (p < 0.001), and the level of PDE4 mRNA in AD patients significantly decreased following treatment (p < 0.001) Our study indicates that there is an increased level of PDE4 in AD lesions, suggesting that PDE4 plays an important role in the pathogenesis of AD. Targeting PDE4 (using PDE4 inhibitors) may herald a new era in the treatment of AD.

Effectiveness of a combined 308-nm excimer lamp and topical mid-potent steroid treatment for facial vitiligo: a preliminary, randomized double-blinded controlled study.

Facial vitiligo has considerable psychological and emotional impacts. Though topical corticosteroids are the mainstay treatment, adverse reactions are a concern for prolonged use. Additionally, 308-nm excimer lamps have been widely used in vitiligo. This study aimed to assess the effectiveness of a combined 308-nm excimer lamp and topical steroid therapy compared with the lamp alone for treating facial vitiligo. Symmetrical, nonsegmental facial vitiligo subjects were recruited. All facial lesions were irradiated with a 308-nm excimer lamp twice weekly for a total of 24 sessions. The lesions on each side of the face were randomly allocated to have topical mometasone furoate cream or the cream base alone applied once daily for 12weeks. Clinical improvement was evaluated by a blinded dermatologist and the participants. A total of sixteen sides of the face were assessed in the study. By the 12th week, 87.5% of the lesions treated with the combination regimen and 50% of the lesions treated with monotherapy showed good to excellent repigmentation. From the subjects' perspectives, there were significant differences between both treatments at week 4 and week 8 (p = 0.05) but not at week 12. No serious adverse effects were reported. A combination of excimer lamp therapy and once-daily application of topical mometasone cream was effective and could accelerate the treatment outcomes without serious adverse reactions. This may be an alternative regimen for treating facial vitiligo.

Miescher’s cheilitis: A case report with literature review

Miescher’s cheilitis is an inflammatory disorder characterized by chronic lip swelling due to granulomatous inflammation. It is rare disorder first described by Miescher in 1945. It is monosymptomatic form of Melkersson-Rosenthal syndrome. We report a case of Miescher’s cheilitis in a 59-year old lady presented with recurrent swelling and erythema of upper lip and submental area with no features of facial palsy and fissuring of tongue. Laboratory tests including serum complement C3, C4 and C1 esterase inhibitor functional were within normal limits. The biopsy from the upper lip revealed dermal edema, dilated lymphatic channels and multiple granulomas. After exclusion of other causes of orofacial granulomatosis, the diagnosis of Miescher’s cheilitis was made. Patient was treated with oral hydroxychloroquine and topical tacrolimus and mometasone cream with gradual improvement.

Topical safety and vasoconstrictive assay-based bioequivalence of a new reformulated mometasone cream

Objectives: A new improved mometasone furoate (Elocon™) cream with an emulsification system that produces a stable emulsion has been developed. In order to register the product in various markets, it was essential to ensure the cream was topically well tolerated and that it was bioequivalent to the reference product.Methods: Phase I clinical studies were performed to assess the local safety and tolerability upon multiple dosing of this new cream as well as to assess the single-dose bioequivalence relative to the marketed product. Bioequivalence was assessed using a vasoconstrictive assay (VCA) after a dose-duration pilot study was completed with the marketed Elocon cream.Key findings: The new mometasone cream and its vehicle were nonirritating in healthy subjects during 21-day patch application (MCII <0.025). The positive control was moderately irritating in the same study. The pivotal VCA study enrolled 162 subjects with 105 detectors included in the analysis of bioequivalence. In the 105 detectors, the ratio (×100%) of AUEC values at ED50 for test vs. standard (90% CI) was 112.91% (105.55, 120.87), within the bioequivalence criteria of (80, 125).Conclusions: These studies supported the registration of reformulated mometasone cream in various markets.

Repeated Measure Analysis of Dermatitis Symptoms Evolution and Patient-Reported Outcome in N06C4: A Phase 3 Randomized Trial of Mometasone Furoate in Breast Cancer Patients Receiving Radiation Therapy

The evolution of dermatological symptoms over time and its relationship to PRO are not well quantified. The recently published Phase III N06C4 prospective trial showed that mometasone cream was better than placebo in preventing radiation (RT) dermatitis by Skindex-16 (SD16) and Skin Toxicity Assessment Tool (STAT). This study examined the temporal profile of PRO in determining the effect of mometasone cream on acute skin toxicity when time factor was considered.

Efficacy and Patient-Reported Outcomes of a New Mometasone Cream Treating Atopic Eczema

This double-blind controlled phase II study was conducted to compare a newly developed formulation of mometasone furoate with a water content of 33% (Monovo® Cream) and with a smooth consistency versus the commercially available fatty cream of mometasone furoate (Ecural® Fettcreme) in terms of efficacy, cosmetic properties, and patients’ acceptance. In 20 patients with mild to moderate atopic eczema, the preparations were tested intraindividually in a randomized mode and in two comparable lesion areas. Both preparations were equally effective and well tolerated. Due to improved cosmetic properties, the new formulation was preferred by the patients when asked for preferential use. Quality of life could be improved by treating with both preparations.

Bioavailability, Antipsoriatic Efficacy and Tolerability of a New Light Cream with Mometasone Furoate 0.1%

Mometasone furoate, a potent glucocorticoid (class III) with a favorable benefit/risk ratio, has emerged as a standard medication for the treatment of inflammatory skin disorders. The purpose of the investigation presented here was to determine the noninferiority of a topical mometasone formulation, a light cream (O/W 60/40 emulsion) with mometasone furoate 0.1% (water content of 33%) versus marketed comparators. Using the vasoconstrictor assay, a strong blanching effect of the new cream (called Mometasone cream) comparable to that of a mometasone comparator, a fatty cream with mometasone furoate 0.1%, could be demonstrated. Thus, the topical bioavailability of the active ingredient mometasone furoate (0.1%) was regarded to be similar for Mometasone cream and the mometasone comparator. Using the psoriasis plaque test, a strong antipsoriatic effect comparable to that of the mometasone comparator was found for Mometasone cream after 12 days of occlusive treatment. A nearly identical reduction in the mean infiltrate thickness and similar mean AUC values were noted with both formulations confirmed by clinical assessment data. The noninferiority of Mometasone cream to its active comparator with respect to the AUC of change to baseline in infiltrate thickness was demonstrated. Both medications were well tolerated. Overall, Mometasone cream and the mometasone comparator showed similar efficacy and tolerability. Mometasone cream, in addition to its high potency and good tolerability, provides the properties of a light cream, which might make this new medication particularly suitable for application on acutely inflamed and sensitive skin.

Comparison of Provider-Assessed and Patient-Reported Outcome Measures of Acute Skin Toxicity During a Phase III Trial of Mometasone Cream Versus Placebo During Breast Radiotherapy: The North Central Cancer Treatment Group (N06C4)

Considerable interobserver variability exists among providers and between providers and patients when measuring subjective symptoms. In the recently published Phase III N06C4 trial of mometasone cream vs. placebo to prevent radiation dermatitis, the primary provider-assessed (PA) endpoint, using the Common Toxicity Criteria for Adverse Events (CTCAE), was negative. However, prospectively planned secondary analyses of patient-reported outcomes (PROs), using the Skindex-16 and Skin Toxicity Assessment Tool (STAT), were positive. This study assesses the relationship between PA outcomes and PROs. Pearson correlation coefficients were calculated to compare the three tools. Statistical correlations were defined as follows: <0.5, mild; 0.5-0.7, moderate; and >0.7, strong. CTCAE dermatitis moderately correlated with STAT erythema, and CTCAE pruritus strongly correlated with STAT itching. CTCAE pruritus had a moderate correlation with Skindex-16 itching. Comparing the 2 PRO tools, Skindex-16 itching correlated moderately with STAT itching. Skindex-16 burning, hurting, irritation, and persistence all showed the strongest correlation with STAT burning; they showed moderate correlations with STAT itching and tenderness. The PRO Skindex-16 correlated well with the PRO portions of STAT, but neither tool correlated well with CTCAE. PROs delineated a wider spectrum of toxicity than PA measures and provided more information on rash, redness, pruritus, and annoyance measures compared with CTCAE findings of rash and pruritus. PROs may provide a more complete measure of patient experience than single-symptom, PA endpoints in clinical trials assessing radiation skin toxicity.

Follicular mucinosis: a case report

A case of follicular mucinosis is reported. A 60-year-old female was admitted to the hospital for facial nodules and infiltrated plaques over 1 year. Dermatological examination revealed skin-colored or pink nodules on the forehead and infiltrated plaques on the left chin covered with yellow crusts. The biopsy of a skin lesion demonstrated a mixed infiltrate of inflammatory cells which were predominated by lymphocytes, in dermis and around subcutaneous blood vessels and appendages. Reticular degeneration of follicular epithelial cells and formation of cysts were also observed. Alcian blue stain displayed massive mucin deposition in cyst cavity. After treatment with oral acitretin and prednisone and topical mometasone cream and isotretinoin gel for 2 months, the lesions disappeared. Key words: Mucinosis, follicular; Diagnosis; Therapy

Mometasone cream versus pimecrolimus cream for the treatment of childhood localized vitiligo

Background: With regard to the lack of effective treatment modalities for childhood localized vitiligo, the search for newer therapeutic agents continues.Objective: To conduct an open, comparative trial to evaluate the clinical efficacy and safety of topical mometasone cream and pimecrolimus cream in the treatment of childhood vitiligo.Methods: Fifty patients with childhood vitiligo were included in the study. Patients were treated for 3 months either with mometasone cream (0.1%) once daily or with pimecrolimus cream (1%) twice daily.Results: Forty patients, 20 from each group, completed the study. The two drugs were found to be statistically significantly effective for diminishing lesion size (Z = 3.070,p = 0.002 andZ = 3.845,p < 0.001, respectively). There were no statistical differences between the two drugs:Z = 1.427,p = 0.154 (mometasone non-inferiority to pimecrolimus). The mean repigmentation rate was 65% in the mometasone group and 42% in the pimecrolimus group at the end of therapy. Atrophy, telangiectasia and erythema were observed in two patients (10%) in the mometasone cream group and a burning sensation and pruritus were observed in two patients (10%) in the pimecrolimus cream group; drop-out was not related to the observed adverse effects.Conclusion: Mometasone cream was found to be effective in the treatment of vitiligo on any part of the body. Pimecrolimus was not effective on the body except for the face in childhood localized vitiligo.

Comparison of Provider Assessed and Patient Reported Outcome Measures of Acute Skin Toxicity during a Phase III Trial of Mometasone Cream versus Placebo during Breast RT from the North Central Cancer Treatment Group (N06C4)

Comparison of Provider Assessed and Patient Reported Outcome Measures of Acute Skin Toxicity during a Phase III Trial of Mometasone Cream versus Placebo during Breast RT from the North Central Cancer Treatment Group (N06C4)

Mometasone cream versus pimecrolimus cream for the treatment of childhood localized vitiligo

Mometasone cream versus pimecrolimus cream for the treatment of childhood localized vitiligo

Mometasone furoate in the treatment of atopic dermatitis in children

AbstractBackground Efforts are being made to find a non‐fluorinated topical corticosteroid with higher anti‐inflammatory activity for use in chronic dermatoses.Patients and methods In a third‐party blind evaluation study we compared Mometasone cream, 0.1% once a day, with Clobetasone cream, 0.05% twice daily, in 60 children with atopic dermatitis treated for 3 weeks. At each visit carried out at days 0, 7, 14. 21 we evaluated signs and symptoms, therapeutic response and skin atrophy. Further visits were carried out at days 2, 3, 4 to evaluate the onset of action. During the first and last visit we also carried out laboratory tests including blood cortisol.Results Mometasone was more effective and rapid in reducing signs and symptoms than Clobetasone. The difference between the two drugs was statistically significant (P &lt; 0.05) from the fourth day of treatment for pruritus, and from days 7 and 14 for induration and eythema, respectively. At the end of the study 50% of the patients treated with Mometasone showed no symptoms vs 6.7% of those treated with Clobetasone. Topical and systemic tolerability were very good and laboratory tests were not significantly affected by either drug.Conclusions Monometasone cream seems to represent an interesting therapeutic approach to chronic dermatoses, i.e., atopic dermatitis.