Topical sodium valproate-loaded nanospanlastics versus conventional topical steroid therapy in alopecia areata: a randomized controlled study.

BACKGROUND: A myriad of therapeutic modalities for alopecia areata are available; however, none is of high level of evidence, creating an immense need for the evaluation of other treatment modalities, of which topical sodium valproate is of potential role via proposed decrease in beta-catenin breakdown, despite its well-known side effect of hair fall as an oral therapy. OBJECTIVE: Evaluating the efficacy and the safety of sodium valproate (SV)-loaded nanospanlastics, in comparison to topical corticosteroids, this is the currently available gold standard topical treatment for patchy AA. METHODOLOGY: A total of 66 patients with patchy AA were randomly assigned to receive either topical mometasone furoate lotion or topical SV applied twice daily to all patches except a control patch, which was left untreated. Clinical, trichoscopic and biochemical assessments of beta-catenin tissue levels and Axin-2 gene expression were carried out at baseline and after 3 months. RESULTS: Both therapeutic modalities were comparable. Potential efficacy was highlighted by significant improvement in the representative patch, the largest treated patch, to the control patch, the smallest untreated patch in both steroid and valproate groups (p = 0.027, 0.003 respectively). Both beta-catenin levels and Axin-2 gene expression were reduced after treatment, pointing to the inhibitory effect of dominating uncontrolled inflammatory milieu. Baseline beta-catenin was found to significantly negatively correlate with improvement in the representative patch in patients with baseline level above 0.42 ng/ml (p = - 0.042). CONCLUSION: Both topical SV and steroids are of comparable modest efficacy. Thus, further evaluation of SV is due in combination with intralesional steroids and other anti-inflammatory treatment modalities, together with developing individualized approaches based on baseline beta-catenin level. GOV IDENTIFIER: NCT05017454, https://clinicaltrials.gov/ct2/show/NCT05017454 .

Estimation of serum and tissue level of interleukin-15 (IL-15) and IL-15 receptor alpha (IL-15Rα) in mycosis fungoides before and after phototherapy: An interventional cohort study.

BACKGROUND: Mycosis fungoides (MF) is a chronic, highly recurrent cutaneous T-cell lymphoma, whose pathogenesis has not yet been fully elucidated. Interleukin-15 was previously highlighted as a viability factor for cutaneous T-cell lymphoma with previous studies shedding light on its role in pathogenesis of MF and its plausibility as a potential therapeutic target. OBJECTIVE: This study was conducted to evaluate serum and tissue expression of IL-15 and IL-15Rα in early cases of MF (IA, IB, IIA) at baseline and following phototherapy. MATERIALS AND METHODS: Fourteen early MF cases were recruited. Samples were withdrawn prior to starting phototherapy treatment and following near complete clearance of the biopsied lesion or after a maximum of 36 sessions of phototherapy. Samples were assessed for change in expression of IL-15 and IL-15 Rα levels following treatment, whose levels were compared to healthy controls. RESULTS: Serum and tissue levels of IL-15 and IL-15Rα in early MF cases were significantly higher at baseline than their levels following phototherapy treatment and higher than healthy controls. However, they dropped significantly following treatment with no statistical difference between treated cases and controls, apart from serum IL-15Rα that remained significantly elevated than controls. CONCLUSION: Interleukin-15 and its receptor alpha appear to contribute to the pathogenesis of MF, being significantly elevated than healthy controls, which were normalized following phototherapy treatment, apart from serum IL-15Rα, which remained elevated. Controlling IL-15/IL-15Rα expression is a newly proposed mechanism of action of phototherapy in MF.

Comparative Analysis of the Most Used Versus the Recently Developed Vitiligo Activity and Extent Scores and Their Change with Treatment.

INTRODUCTION: There are diverse assessment tools for vitiligo, with no standardized approach that helps unify treatment outcome measures. Thus, comparing different treatment modalities and developing evidence-based recommendations for vitiligo management has been quite challenging. OBJECTIVES: We compared the most commonly used tools assessing both vitiligo activity and extent, namely, Vitiligo Disease Activity Score (VIDA) and Vitiligo Area and Severity Index (VASI) score to their newly developed counterparts, namely, Vitiligo Extent Score Plus (VES plus) and Vitiligo Signs of Activity score (VSAS), to provide insights that would help set recommendations for a unified outcome assessment protocol for vitiligo patients. METHODS: Thirty-six active non-segmental vitiligo cases were recruited, 30 of whom completed 48 sessions of narrow band ultraviolet B (NB-UVB). Patients were assessed for both extent and activity both before and after treatment with NB-UVB. Scores were correlated. Additionally, VES plus was assessed for its reliability in comparison to VASI score. RESULTS: Both extent (VASI and VES plus) and activity scores (VIDA and VSAS) showed significant improvement following treatment. Additionally, VES plus and VASI were positively correlating both before and after treatment as well as their percent change. Furthermore, VES plus proved as reliable as VASI. Regarding activity scores, total, hypochromic and Koebner VSAS only correlated with VIDA following treatment. Confetti VSAS neither correlated with VIDA before nor after treatment. CONCLUSIONS: VES plus and VASI scores have proven of comparable reliability. While examination-based VSAS score comes as an additive tool to the history-based VIDA score.

The value of adding platelet-rich plasma (PRP) to noncultured epidermal cell suspension (NCECS) in surgical treatment of stable resistant vitiligo: A self-controlled randomised double-blinded study.

BACKGROUND: Noncultured epidermal cell suspension (NCECS) is a commonly used surgical treatment for resistant stable acral vitiligo and vitiligo overlying joints. Platelet-rich plasma (PRP) has been reported to enhance the repigmentation response of different therapeutic modalities for vitiligo, including vitiligo surgery. OBJECTIVE: To assess the value of adding of PRP to NCECS in the surgical treatment of acral vitiligo and vitiligo overlying joints. PATIENTS AND METHODS: This self-controlled randomised trial included 15 patients with 30 lesions in which NCECS suspended in PRP was performed for one lesion and NCECS in ringer's lactate for another comparable lesion. Following NCECS, patients underwent thrice weekly excimer light sessions for 3 months. After 8 weeks, patients underwent preliminary assessment. By the end of the 3 months, both lesions were compared as regards improvement in surface area and pigmentation. Additionally, physician global assessment was made by a blinded investigator. RESULTS: Significant improvement was reported in both lesional extent and pigmentation (after PRP and lactated ringer NCECS) with no statistical difference between them. CONCLUSION: Despite previous promising results, suspending NCECS in PRP offered no privilege in surgical treatment of acral vitiligo and vitiligo overlying joints, which are quite resistant to treat. PAN AFRICAN CLINICAL TRIAL REGISTRY ID: PACTR202108873035929, Date: 16 August 2021.

Different vitiligo characteristics as predictors of increased risk of metabolic syndrome and insulin resistance: A case-control study.

BACKGROUND: Autoimmune and metabolic disturbances have been reported in association with vitiligo, highlighting possible systemic associations that should be considered. AIMS: To assess the possible association of metabolic syndrome (MetS) as well as insulin resistance (IR) with vitiligo in different age groups. METHODS: This case-control study included 142 patients with vitiligo aging ≥ 6 years and 142 age- and sex-matched controls. Participants were assessed for MetS using the International Diabetes Federation (IDF) criteria in addition to IR via homeostasis model assessment of IR (HOMA-IR). The study was registered at Clinical Trials.gov, Identifier: NCT03622320, on August 9, 2018. RESULTS: As per the IDF criteria, patients with vitiligo showed significantly more frequent association with high fasting plasma glucose levels, high blood pressure readings, central obesity, dyslipidemia, and MetS than controls (p = 0.020, p = 0.034, p = 0.014, p < 0.001, and p = 0.002, respectively). Moreover, patients with vitiligo have significantly higher levels of fasting insulin and HOMA-IR (p ≤ 0.001). Results obtained from patients with vitiligo and controls with coexistent MetS/IR demonstrated vitiligo as a risk factor for both MetS and IR. Univariate and multivariate logistic regression highlighted that older age was the significant independent predictor for MetS and IR. CONCLUSION: Patients with vitiligo showed a significantly higher incidence of MetS than controls. Vitiligo per se can be considered a risk factor for MetS and IR. Therefore, regular follow-up and early metabolic derangement diagnoses are mandatory.

Possible enigmatic link between serum leptin and vitiligo with its metabolic derangements: A comparative controlled study.

OBJECTIVE: Serum leptin, an adipocytokine of interleukin-6 family, has been linked to vitiligo-associated metabolic derangements. Additionally, it has been proposed as an inflammatory mediator with possible influence on vitiligo pathogenesis. This study aimed at assessing serum leptin in vitiligo patients compared to controls and whether different vitiligo characteristics have an influence on serum leptin levels. METHODS: In this hospital-based, cross-sectional case-control study, 70 vitiligo (35 segmental vitiligo (SV) and 35 Non-segmental vitiligo (NSV)) and 70 age- and sex-matched controls were assessed for different anthropometric measurements including waist circumference (WC), index of central obesity (ICO), and body mass index (BMI) as well as serum leptin levels. RESULTS: Central obesity as per ICO showed no significant difference between patients and controls. Additionally, patients of SV and NSV collectively showed significant higher incidence of +ve serum leptin than their controls (41.4% vs. 22.9%%, P: 0.019). Mere presence of vitiligo and ICO >0.5 were highlighted as independent predictors of +ve serum leptin (P: 0.009 and <0.001, respectively). LIMITATION: Inability to determine a cause/effect relationship based on a cross-sectional study. Larger scale studies are needed to affirm our findings. CONCLUSION: Mere presence of vitiligo being an independent predictor for high serum leptin could be either a contributor to pathogenesis of vitiligo or a sequel to accumulating evidence of metabolic nature of vitiligo. This is likely to influence the investigative panel and treatment protocol for vitiligo patients.

Efficacy of narrow band UVB with or without OMP in stabilization of vitiligo activity in skin photo-types (III-V): A double-blind, randomized, placebo-controlled, prospective, multicenter study.

BACKGROUND: NB-UVB has long been the vitiligo management pillar with capability of achieving the main treatment outcomes; repigmentation and stabilization. Its stabilizing effect in dark skin has been debatable. However, randomized controlled trials regarding NB-UVB ability to control disease activity are lacking. PURPOSE: To assess stabilizing effect of NB-UVB in comparison to systemic corticosteroids, the mainstay in vitiligo stabilization, in skin photo-types (III-V). METHODS: This is a multicenter, placebo-controlled, randomized, prospective study. Eighty patients with active nonsegmental vitiligo (NSV) (Vitiligo disease activity (VIDA) ≥2) were randomized to either NB-UVB and placebo (NB-placebo) or NB-UVB and dexamethasone oral mini-pulse (OMP) therapy (NB-OMP) for 6 months. Sixty four patients completed the study, 34 in the NB-OMP group and 30 in the NB-placebo group. Patients were evaluated fortnightly according to presence or absence of symptoms/signs of activity. RESULTS: In spite of earlier control of disease activity observed in the NB-OMP group, it was comparable in both groups by the end of the study period. Disease activity prior to therapy, but not extent, was found to influence control of activity in both groups. Thus, NB-UVB is a safe sole therapeutic tool in vitiligo management. Not only does it efficiently achieve repigmentation, but also it is a comparable stabilizing tool for systemic corticosteroids in spite of slightly delayed control. CONCLUSION: NB-UVB is the only well-established vitiligo therapy that can be used solely whenever corticosteroids are contraindicated or immune-suppression is unjustified. Nonetheless, its combination with corticosteroids expedites response and improves compliance.

Early localized vitiligo, a medical emergency: Long-term follow-up study.

In spite of multiple therapeutic regimens for vitiligo, disease relapse remains a challenge. Most guidelines consider systemic treatments only in rapidly progressive disease with wider surface areas. This delay in halting the immune attack, may give the chance for further disease progression as well as establishment of resident memory T-cell population predisposing to future relapses. To assess the ability of early systemic therapy of localized (<2% BSA), recent onset (<6 months) vitiligo to control disease activity and minimize the possibility of recurrence. Twenty-five patients with recent onset (<6 months), localized (<2% BSA) vitiligo were included. Patients received pulse dexamethasone therapy for 6 months plus topical treatments and NB-UVB sessions. Patients were followed monthly as regards percent of repigmentation and VIDA score. To detect recurrence, biannual assessment was done for 4 years. Eighty-four percent of patients had acrofacial lesions and 44% had facial lesions. Arrest of activity was achieved after 3.65 ± 2.19 months. Complete repigmentation was achieved in a mean duration of 6.88 ± 0.2 months. At the end of the 4-year follow up, recurrence occurred in 32% of patients. In spite of recurrence, localized disease (<2% BSA) was secured. A significantly higher incidence of recurrence was associated with cases with bilateral distribution of lesions. Early systemic immunomodulation for recent localized vitiligo is a successful approach to achieve early control of disease activity and minimize the incidence of recurrence. Such cases should not be overlooked but managed as early as possible; it is a race against time.

Comparative analysis of the body surface area calculation method used in vitiligo extent score vs the hand unit method used in vitiligo area severity index.

BACKGROUND: Vitiligo Area and Severity Index (VASI) is standing on the top of the cited and implemented scoring tools for vitiligo. However, an easily applicable and time-saving tool has been a need. AIM: This cross-sectional study aimed at comparing the body surface area (BSA) calculation method used in Vitiligo Extent Score (VES) in comparison with the hand unit method used in VASI and to consider the implementation of VES as a user-friendly tool by doctors as applied to observed clinical patterns of NSV in our population. METHODS: For each patient with NSV, vitiligo was assessed using both VES and VASI as well as vitiligo disease extent by hand units. RESULTS: Vitiligo extent score and VASI scores showed a strong significant correlation. Both scores were found reliable in spite of the presence of unrepresented areas in the VES with tendency of the values for the BSA by the VES to be lower than that by hand units. CONCLUSION: In comparison with VASI, VES has proven to be a clear, user-friendly score for vitiligo assessment. However, special concern is to be given for required modification for pediatric population. A slight modification may be required regarding the pediatric population.

New insights into leukotrichia in nonsegmental vitiligo: A cross-sectional study.

BACKGROUND: Leukotrichia has been considered a predictor of poor outcome in vitiligo. However, studies considering the different clinical aspects of leukotrichia in vitiligo patients are few. AIM: Our aim was to conduct a detailed clinical study to provide insights into the relevance and associations of leukotrichia in non-segmental vitiligo. METHODS: In this cross-sectional study, vitiligo patients attending the dermatology outpatient clinic and phototherapy unit at Cairo University Hospital over a period of 6 months (April-September 2016) were included. Family history, clinical details, the Vitiligo Global Issues Consensus Conference classification, the Dermatology Life Quality Index, Vitiligo Area and Severity Index, Vitiligo Extent Score, Vitiligo Disease Activity Score and Vellus Score were determined and these measurements were correlated to leukotrichia. RESULTS: Out of the 101 patients studied, leukotrichia was found in 47 (46.5%) patients, with vellus hair involved in 37 (78.7%), terminal hairs in 30 (63.8%) and both in 20 (42.5%) patients. Vellus hair involvement was significantly higher in generalized bilaterally symmetrical vitiligo than in acrofacial or unclassified vitiligo. The incidence of scalp leukotrichia also was higher in generalized symmetrical vitiligo than in acrofacial vitiligo. The Vellus Score showed significant associations with Vitiligo Area and Severity Index, Vitiligo Extent Score and the Dermatology Life Quality Index. LIMITATIONS: This was a short-term study with a small sample size. Prognostic and therapeutic correlations were not studied; prospective longitudinal studies are needed for further evaluation. CONCLUSION: Leukotrichia was found in almost half of the studied sample and its frequency varied among the different types of vitiligo.