Comparison of the Diagnostic Accuracy of Teledermoscopy, Face-to-Face Examinations and Artificial Intelligence in the Diagnosis of Melanoma.

Background: Rapid diagnosis of melanoma is necessary for a good prognosis. Using teledermatology and artificial intelligence for this issue is developing, but its diagnostic accuracy is less measured in a clinical setting. Objective: The purpose of this study was to assess the diagnostic accuracy of the teledermoscopy method using the FotoFinder device as well as the Moleanalyzer Pro artificial intelligence (AI) Assistant and to compare them with the face-to-face clinical examination for the diagnosis of melanoma confirmed with histopathology. Methods: Thirty melanocytic moles of 29 patients were included in the study. Each mole was assessed face-to-face, using FotoFinder teledermoscopy and Moleanalyzer Pro software methods. The results obtained from each method were compared with the results of the gold standard (pathology). The sensitivity and specificity of the three methods were calculated for malignant and borderline versus benign lesions. Inter-method reliability between a gold standard and other methods was evaluated using per cent agreement and Cohen's kappa coefficient. Results: Five moles had a histopathological diagnosis of melanoma, and six and 19 moles were diagnosed as borderline and benign, respectively. Sensitivities and specificities were, respectively, as follows: face-to-face (90.9%, 57.9%), FotoFinder teledermoscopy (63.6%, 78.9%), FotoFinder® Moleanalyzer Pro (36.4%, 42.1%). Agreement with biopsy-obtained diagnosis categories of benign, borderline and malignant for face-to-face was 63.33%, FotoFinder teledermoscopy 73.33%, and FotoFinder® Moleanalyzer Pro 40%. Conclusions: Teledermoscopy had the highest agreement with reference diagnosis as well as the highest specificities that caused a reduction of biopsy referrals. The FotoFinder® Moleanalyzer Pro had the lowest agreement. Therefore, it cannot replace dermatologist decision making.

Pathological and Immunohistochemical Assessment of Aging of the Abdominal Skin Treated with Carboxytherapy: A Randomized, Split-body Trial.

Background: Skin aging as a continuous and irreversible process is mainly the result of alterations of function and structure of the dermis. Among the modalities used for treating skin aging, carboxytherapy has been introduced as a safe minimally-invasive method for rejuvenation, reparation, and reconditioning of the skin. Objective: We assessed the efficacy of carboxytherapy for the treatment of intrinsic skin aging through pathological and immunohistochemical (IHC) investigations. Methods: Our study was a split-body, randomized clinical trial on 15 female patients with intrinsic skin aging of the abdomen. Carboxytherapy was performed on one side of the abdomen, weekly for 10 sessions, while the other side was left untreated. Two weeks after the last session, skin biopsies were taken from both sides of the abdomen. Staining with hematoxylin-eosin, Masson-trichrome, and Orcein Giemsa was performed for the assessment of epidermal and dermal thickness, collagen, and elastin organization, respectively. IHC examination was performed for investigation of TGF-ß1 and VEGF. Results: Pathological examination showed a significant increase in epidermal and dermal thickness and re-organization of collagens and elastic fibers with carboxytherapy. IHC examinations revealed a significantly increased expression of TGF-ß1 and VEGF with carboxytherapy. Conclusion: Our study demonstrated the effectiveness of carboxytherapy in treating and reversing intrinsic aging skin through pathological and IHC studies.

Efficacy Evaluation of a Hyaluronic Acid Dermal Filler Containing Mannitol: Clinical and Aesthetic Assessment Using High-Frequency Ultrasound.

BACKGROUND: Mannitol may be a good excipient for hyaluronic acid (HA) filler. OBJECTIVE: This study aimed to assess the tolerability and effectiveness of a mannitol-containing HA filler for the improvement of nasolabial folds (NLFs). PATIENTS AND METHODS: Thirty Middle Eastern participants aged 18 to 65 years with moderate-to-severe NLFs on the Wrinkle Severity Rating Scale (WSRS) received 1 to 2 mL of a HA filler containing mannitol in both NLFs. Wrinkle Severity Rating Scale; volume, depth, and area of NLFs; and ultrasound parameters were measured at baseline, Weeks 2, 12, and 24 after the injection. Adverse events and participants' satisfaction were recorded in all follow-up visits. RESULTS: Eighty-nine percent, 86%, and 61% of participants showed at least one grade improvement in WSRS, at Weeks 2, 12, and 24, respectively. The area and volume of NLFs significantly decreased compared with baseline (p-value < .01). In severe NLFs, echo density of the dermis significantly increased at Week 2. Participants reported great satisfaction with the treatment, and adverse events were mainly mild and transient. One patient had significant pain during injection, but this resolved without sequelae. CONCLUSION: The tested mannitol-containing HA filler showed to be effective in Middle Eastern participants. The safety will require a follow-up larger study.

Fabrication and efficacy assessment of combination of brimonidine and ivermectin for treatment of papulopustular rosacea.

BACKGROUND & AIM: Rosacea is a chronic inflammatory, multifactorial disease for which combination therapy could be an effective treatment. In this study, we evaluate the effect of the combination therapy of brimonidine 0.33% and ivermectin 1% as a single cream for the treatment of papulopustular rosacea. METHOD: A stable and appropriate formulation was prepared by adding the aqueous phase to the lipid phase while being stirred. The stability and physicochemical properties of the formulation were evaluated under accelerated conditions. Twelve patients (36-60 years) with mild to moderate papulopustular rosacea and a Demodex count of five or more were treated with the combination of brimonidine 0.33% and ivermectin 1% cream. Clinician's Erythema Assessment (CEA), Patients Self-Assessment (PSA), skin erythema (ΔE) and lightness (ΔL), and skin biophysical parameters including transepidermal water loss (TEWL), skin hydration, pH, and sebum content, as well as erythema and melanin index and ultrasound parameters, were measured before treatment and 4 and 8 weeks after. Adverse drug reactions were also recorded. RESULTS: CEA and PSA decreased significantly from 3 to 2 after 8 weeks, respectively (p-value = 0.014 for CEA and 0.010 for PSA). ΔE and ΔL, as well as skin erythema index and TEWL improved after 8 weeks of treatment (p < 0.05). Two patients withdrew from the study in the first week because of local adverse effects; one developed flushing following treatment and left the investigation after 4 weeks and another patient withdrew from the study after 4 weeks due to deciding to become pregnant. CONCLUSION: Eight-week treatment with the combination of brimonidine 0.33% and ivermectin 1% was shown to be effective for improvement of erythema and inflammatory lesions in mild to moderate papulopustular rosacea.

Terbinafine-resistant T. indotineae due to F397L/L393S or F397L/L393F mutation among corticoid-related tinea incognita patients.

Tinea incognita (TI) can mimic other dermatoses, presenting a diagnostic challenge for dermatologists. In some uncertain cases, it is crucial to accurately identify the causative agent using internal transcribed spacer (ITS) sequencing. The global issue of drug-resistant dermatophytosis is increasing, with Trichophyton (T.) indotineae being the main cause. This study presents four cases of TI (diagnosed as eczema) by terbinafine-resistant T. indotineae strains and reviews the current global TI epidemiology based on geographical continent and related conditions. Furthermore, squalene epoxidase (SQLE)-associated resistance mechanisms are evaluated. Lesions caused by terbinafine-resistant T. indotineae strains do not respond to allylamine antifungals, thus allowing the infection to spread. Among T. indotineae isolates, the SQLE F397L substitution is the most prevalent mutation contributing to azole resistance. F397L and L393F replacements in SQLE were detected in all isolates that exhibited high-level resistance. L393S was seen in isolates with low-resistant strains. Interestingly, and for the first time, an L393F amino acid substitution in the SQLE gene product was detected in the Iranian clinical T. indotineae strain. Also, a genomics-based update on terbinafine resistance that focuses on T. indotineae is discussed in this study.

High-frequency ultrasound evaluation of morphea: Retrospective analytical study.

BACKGROUND: To date, there are no accepted outcome measures to monitor morphea, and consensus on specific monitoring criteria for morphea remains elusive. A few studies have assessed the criterion validity of skin ultrasound in morphea. So, in this study, we approach ultrasound findings in morphea lesions. MATERIAL AND METHODS: This was a retrospective-analytical study conducted between December 2021 and May 2023. Patients were clinically evaluated at a dermatology outpatient clinic and then referred for high-frequency ultrasound (HF-US) evaluation and were selected to be included in this study. The lesions were confirmed by histopathology as well. Sonographic evaluations were performed on the lesion site and the symmetrical uninvolved other side. Dermal thickness and dermal echogenicities were recorded. Statistical analysis of group differences was performed by using the 2-tailed Student t-test. A p-value of less than 0.05 was considered statistically significant. RESULTS: Forty-one morphea lesions in the inflammatory phase of 27 patients were included in the study. The mean dermal thickness of morphea lesions was 1107.97 ± 414.3 and the mean dermal thickness of the control side was 1094.65 ± 331.06, The difference between these two variables was not statistically significant. The mean dermal density of lesions was 49.13 ± 18.97 and the mean dermal density of the control side was 52.22 ± 25.33. The difference between these two variables was not statistically significant. CONCLUSION: This study shows that HF-US indicated increasing dermal thickness and reducing the dermal density of the morphea lesions in the inflammatory phase confirmed with the histopathology.

Recalcitrant dermatophyte infections: identification and risk factors.

INTRODUCTION: Recalcitrant dermatophytosis is an emerging phenomenon that occurs worldwide, and Trichophyton indotineae is currently the prominent cause. MATERIALS AND METHODS: Skin specimens from patients with tinea infection were obtained by scrubbing and then sectioned into three fragments. Two fragments were subjected to direct microscopic examination and culture, while the third portion was utilized in the PCR method. RESULTS: Isolates were morphologically identified as Trichophyton mentagrophytes/interdigitale complex (n = 60 [83.33%]), Microsporum canis (n = 8 [11.11%]), Trichophyton rubrum (n = 3 [4.16%]), and Epidermophyton floccosum (n = 1 [1.38%]). Among 60 T. mentagrophytes complex isolates, 53 (88.33%) were classified as T. indotineae and seven as T. interdigitale genotype II. The disease duration was longer in the T. indotineae group (P = 0.035). Both Gradient PCR and skin-sampling methods yield similar results in terms of positive and negative cases (P = 1.0000). The time patients stopped their medication did not impact the positive case numbers (P = 0.803). Gender had no effects on the frequency (P = 0.699). Familial contamination, dermatologic disorder, and other underlying conditions did not differ in the two group infections (P > 0.05). Steroid usage is strongly associated with the emergence of tinea infection (P < 0.04). The duration of antifungal administration had a substantial effect on the emergence of resistant organisms (P = 0.05). CONCLUSIONS: Steroid usage, T. indotineae involvement, and prolonged exposure to antifungals were the solid and influential factors in recalcitrant involvement. Regarding quick and suitable diagnosis and treatment, which is essential in preventing recalcitrant cases, we suggest that direct skin sample PCR can meet the demands.

Efficacy and Tolerability of a Hyaluronic Acid-Based Extracellular Matrix for Labia Majora Rejuvenation and Augmentation: A Pilot Study.

A new injectable solution containing low-molecular-weight hyaluronic acid (HA) and a specific amino acid mixture was formulated with proper aesthetic performance for the main signs of facial skin photoaging. The present study aimed to investigate its new application for rejuvenating and augmenting labia majora using clinical and biometric assessments. Three sessions of intradermal injections were performed using 3 ml of test extracellular matrix (ECM) for 10 eligible post-menopause female subjects (age 53.6 ± 7.93 years). The effectiveness of the intervention was assessed by an independent physician using before-and-after pictures based on the physician's global assessment score. Objective biophysical skin assessments, including skin hydration, skin erythema, and melanin index, as well as elasticity parameters including firmness (R0), gross elasticity (R2), and net elasticity (R5), were also performed before the first injection and then on the 2nd and 12th weeks after the last session. Patients' satisfaction and all reported or observed adverse events were documented. At week 12, all the subjects reported an aesthetic improvement of 25% or more in rejuvenation and sagging of the labia major area. A statistically significant improvement was also detected in R0 and R5 at week 12 (p-values 0.005 and 0.022, respectively). Patient satisfaction surveys revealed a median score of 8 at both follow-up visits. The results showed a new indication of the tested HA ECM for providing a beneficial, durable, rejuvenating effect on the labia majora with a good safety profile.

Assessing effectiveness of adding niosomal atorvastatin 1% ointment to topical calcineurin inhibitor treatment in non-segmental vitiligo.

BACKGROUND: Treatment of vitiligo is still a big challenge for dermatologists. The efficacy of statins in the treatment of vitiligo is controversial. AIM AND OBJECTIVE: We studied possible therapeutic effect of topical 1% niosomal atorvastatin ointment combined with topical 0.1% tacrolimus in treatment of non-segmental vitiligo. METHODS: This is a triple blind, pilot, randomized placebo-controlled trial (RCT) that was performed in dermatology clinic. All the patients used topical 0.1% tacrolimus cream twice daily (BD). Moreover, the intervention group participants used topical 1% niosomal atorvastatin ointment, and control group participants were prescribed placebo ointment, BD. Patients were evaluated using vitiligo area surface index (VASI) score and patients' satisfaction at baseline and after 3 months treatment. RESULTS: The mean patient satisfaction in the intervention and control groups were 5 ± 1.4 and 3.5 ± 1.9; the difference between groups was not statistically significant (p = 0.9). We found statistically significant difference in VASI score before and after treatment in both intervention and control groups (p = 0.01 and p = 0.03, respectively). However, comparison of the VASI score between groups was not statistically significant (p = 0.62). We also found no significant correlation between VASI score and other variables. CONCLUSION: The result of this study indicates that adding of niosomal atorvastatin 1% ointment to topical calcineurin inhibitor has no additional effect on non-segmental type of vitiligo. Further large studies with different combinations are recommended before any conclusive result can be concluded on efficacy of statins in vitiligo.

Reply to: "Is oral collagen the elixir of youth?"

Following letter provides answers and explanations for the correspoundance titled "Is oral collagen the elixir of youth." They have admitted the strengths of our study and also have raised some questions about it, which we aim to provide answers and explanations.

Eligibility Criteria for Active Ulcerative Pyoderma Gangrenosum in Clinical Trials: A Delphi Consensus on Behalf of the UPGRADE (Understanding Pyoderma Gangrenosum: Review and Assessment of Disease Effects) Group.

At present, there are no standardized guidelines for determining patient eligibility for pyoderma gangrenosum (PG) clinical trials. Thus, we aim to determine which clinical features, histopathological features, or laboratory features should be included in active ulcerative PG clinical trial eligibility criteria for treatment-naïve patients and patients already treated with immunomodulating medications (treatment-exposed patients). This study employed 4 rounds of the Delphi technique. Electronic surveys were administered to 21 international board-certified dermatologists and plastic surgeon PG experts (June 2022-December 2022). Our results demonstrated that for a patient to be eligible for a PG trial, they must meet the following criteria: (i) presence of ulcer(s) with erythematous/violaceous undermining wound borders, (ii) presence of a painful or tender ulcer, (iii) history/presence of rapidly progressing disease, (iv) exclusion of infection and other causes of cutaneous ulceration, (v) biopsy for H&E staining, and (vi) a presence/history of pathergy. These criteria vary in importance for treatment-naïve versus treatment-exposed patients. Given the international cohort, we were unable to facilitate live discussions between rounds. This Delphi consensus study provides a set of specific, standardized eligibility criteria for PG clinical trials, thus addressing one of the main issues hampering progress toward Food and Drug Administration approval of medications for PG.

Is skin autofluorescence a novel non-invasive marker in diabetes? A systematic review and meta-analysis of case-control studies.

Background: The advanced glycation end product (AGE) is produced from the nonenzymatic reaction between glucose and macromolecules by aging. Accumulation of AGE causes functional and structural changes in body proteins that lead to impairment of tissue protein functions. We aimed to validate AGE measurement by skin autofluorescence (SAF) in diabetes mellitus (DM) compared to the nondiabetes population. Materials and Methods: We searched the PubMed, Cochrane, and Scopus databases from their inception till September 18, 2022, for casecontrol studies measuring AGE by SAF. Nonhuman studies, as well as review articles, study proposals, editorials, case reports, or congress posters, were excluded. We used a random effects model to assess the standard mean difference (MD) of age, body mass index (BMI), HbA1c, and SAF between diabetes and nondiabetes individuals. Results: Higher SAF in DM patients indicated more accumulation of AGE compared with the nondiabetic population. Furthermore, HbA1c was considerably higher in DM patients. The MD of age, male gender, and BMI were significantly different between the DM individuals, compared with nondiabetic subjects, which can lead to altered SAF level and AGE production. There was a remarkable heterogeneity between diabetes and nondiabetes when measuring age, gender, and BMI, as well as HbA1c and SAF level. Conclusion: This study could not confirm the validity of SAF as a surrogate marker in diabetes patients. Interestingly, metabolic load and high BMI can increase SAF, considerably. Altogether, SAF could be helpful in the future as a marker for metabolic syndrome or diabetes.

Assessment of efficacy of carboxytherapy in management of skin aging through evaluation of gene expression profile: a 2-split randomized clinical trial.

Skin aging is a continuous and irreversible process which results in impairment of the skin role as barrier against all aggressive exogenous factors. It mainly manifests by photoaging, laxity, sagging, wrinkling, and xerosis. Carboxytherapy is considered as a safe, minimally invasive modality used for rejuvenation, restoration, and recondition of the skin. In the current study, the efficacy of carboxytherapy in the treatment of skin aging was assessed through investigation of gene expression profile for Coll I, Coll III, Coll IV, elastin, FGF, TGF-ß1, and VEGF. Our study is a 2-split clinical trial in which carboxytherapy was performed on one side of the abdomen in 15 cases with intrinsically skin aging manifestations weekly for 10 sessions, while the other side of the abdomen was left without treatment. Two weeks after the last session, skin biopsies were taken from both the treated and control sides of the abdomen in order to assess gene expression profile by qRT-PCR. The analysis of gene expression levels for all of Coll I, Coll III, Coll IV, elastin, TGF-ß1, FGF and VEGF genes showed a statistically significant difference between the interventional and control groups. The findings for all of these seven genes showed increase in the interventional group, among which Coll IV, VEGF, FGF, and elastin showed the higher mean changes. Our study confirmed the effectiveness of carboxytherapy in treating and reversing the intrinsically aging skin.Clinical Trial Registration Code and Date of Registration: ChiCTR2200055185; 2022/1/2.

Tolerability and efficacy assessment of an oral collagen supplement for the improvement of biophysical and ultrasonographic parameters of skin in middle eastern consumers.

BACKGROUND: Topical skin care products often do not reach the deeper layers of the skin, and oral hydrolyzed collagen is one of the newest and most popular systemic supplementations for skin rejuvenation. However, there are limited information in case of Middle Eastern consumers OBJECTIVE: The purpose of this study was to evaluate the tolerability and efficacy of an oral collagen supplement for improvement of skin elasticity, hydration, and roughness in Middle Eastern consumers. METHODS AND MATERIALS: It was a 12-week, before-after clinical study, conducted on 20 participants (18 women and 2 men) aged 44.15 ± 5.36 years with skin type III-IV. Skin elasticity parameters (R0, R2, R5, and R7), skin hydration and friction, as well as the thickness and echo density of the dermis, were measured after six and 12 weeks daily intake of the study product, as well as 4 weeks after stopping its use (week 16). Participants' satisfaction was assessed on the basis of their answers to the standard questionnaire, and tolerability of the product was assessed by monitoring the adverse effects. RESULTS: A significant improvement was detected in R2, R5, and skin friction at week 12 (p-values 0.041, 0.012 and <0.01, respectively). At week 16, the values remained at an increased level, which indicates the persistence of the results. The increase of dermis density in week 16 was also significant (p-value = 0.03). Moderate overall satisfaction was reported with the treatment, and a few gastrointestinal complications were reported. CONCLUSION: The study demonstrated that oral collagen peptides could significantly improve the skin elasticity, roughness, and dermis echo density, and they also proved to be safe and well-tolerated.

Updates on Tinea Incognita: Literature review.

Background and Purpose: Tinea incognita (TI), or the other equivalent tinea atypica, is a term used to declare the atypical presentation of dermatophyte infections caused by the administration of steroids or other immunosuppressive medications which modulate the local and systemic immune response. It can mimic other dermatoses; hence making diagnostic challenges for dermatologists. Tina incognita may be misdiagnosed as many dermatoses. Based on previous studies, corticosteroids may cause different clinical manifestations of dermatophytes that might be very different from those that are commonly described. Materials and Methods: This narrative review was conducted using PubMed and Scopus databases. Search terms included "Tinea incognita" and "Atypical dermatophytosis". The search strategy included meta-analyses, randomized controlled trials, clinical trials, observational studies, reviews, and case reports. The search was restricted to articles written in the English language from 2006 to Feb 01, 2023. Moreover, duplicate articles and non-available full-text articles were excluded. The extracted data of the search results were retrieved in this study. The morphological patterns, prevalence, sight of infection, and causative agents were also described. Results: Prevalence of different patterns of TI were recorded as 50% (431 out of 862 cases) for eczema-like lesions followed by psoriasis-like and 6.61% (57 out of 862) for parapsoriasis-like pattern. Moreover, each of the rosacea-like and pyoderma-like lesions equally accounted for 4.98 % of cases (43 out of 862). In addition, the prevalence of causative agents was reported as follows: Trichophyton rubrum accounted for 247 isolates (40%) as the most prevalent, followed by Trichophyton mentagrophytes (n=152, 24%) and Microsporum canis (n=119, 19%). Conclusion: Tinea incognita is a great mimicker; hence, dermatologists should obtain a full medical history of the patients to make correct diagnoses. It is vital to encourage an exact identification of the etiological agent according to the internal transcribed spacer sequencing in some uncertain cases. This review highlights the importance of mycological tests and fast diagnosis of TI, especially in cases of atypical skin lesions, to choose appropriate treatment and avoid the spread of drug-resistant species.

Evaluation of the Effect of Artemisia Absinthium L. Eye-Cream on Infra-Orbital Dark Circle: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

BACKGROUND: The relative darkening of the lower eyelid skin, which is often linked with dark circles, may make you seem fatigued and older than your real age. Considering the recommendations in the sources of Persian medicine regarding Artemisia absinthium L., the purpose of this clinical trial is investigating the effectiveness of cream prepared from the aqueous extraction of A.absinthium to remove periorbital dark circles. MATERIALS AND METHODS: The eye cream is made with 20% of aqueous extract of A.absinthium in the base of the cream. It was standardized based on Artemisinin via HPLC method. For the clinical trial, 60 patients equally enrolled in two drug and placebo groups. Erythema and Pigmentation were evaluated via a mexameter instrument. RESULTS: The cream is standardized, including 1.29±0.02 µg/mg Artemisinin in the product. Finally, 21 and 24 patients reached the end of study in drug and placebo groups, respectively. In these groups, the difference in the mean (SD) DE, DL, Erythema and Melanin factors before and after the research were significant (p0.05). However, the rate of reduction of DE, Erythema, and Melanin and rise of DL is greater in the treatment group than in the placebo group. Furthermore, the mean value of DE and DL factors before the research were significantly different in two groups (p0.001), but after the research did not show a significant difference. The mean value of Erythema factor in the two groups before (p=0.25) and after (p=0.5) did not show a significant difference. The mean value of Melanin after the research between two groups showed a significant difference (p=0.01). CONCLUSION: The results show that the cream prepared from the herbal composition of Persian medicine improves Infra Orbital Dark circle around the eyes.

Efficacy and safety of date palm leaf-based ointment for treatment of cutaneous warts: A pilot clinical trial.

Despite the considerably high prevalence of cutaneous warts, no optimally effective and safe treatment is available. Leaves of date palm (Phoenix dactylifera L.; Arecaceae) have long been used in Iran's folk medicine as a remedy for warts. To assess the state-of-the-art evidence on using P. dactylifera L. for warts, we conducted a systematic review using CINAHL (via EBSCO), Embase, Medline (via PubMed), ProQuest, Scopus, and Web of Science. We conducted an open-label uncontrolled pilot clinical study to evaluate the efficacy and safety of a proprietary topical date palm leaf-based ointment for the treatment of various types of nongenital warts. This study consisted of an 8-week treatment phase and a 4-week follow-up phase. The assessed outcomes included complete clearance, patient satisfaction (on Likert scale), and the occurrence of any adverse effect. The systematic review demonstrated that the effects of date palm on warts have not been scientifically studied. Thirty patients entered the study with a mean age of 29.5 years (SD = 14.04); among which 17 were female and 13 were male. The patients presented diverse types of warts: verruca vulgaris 15 (50%), plantar 9 (30%), plane 2 (7%), periungual 2 (7%), and warts at multiple sites 2 (7%). In this trial, 19 patients (63.3%) experienced complete clearance and 5 patients (16.6%) experienced partial clearance. Eight patients (26.67%) dropped out during the study. 21 (70%) patients were very satisfied (score on Likert scale = 5) while 1 (3.3%) patient with partial clearance was somewhat satisfied (score on Likert scale = 4). No adverse effect was observed. The results of this pilot study indicate that the date palm leaf-based ointment is a promising treatment whose efficacy and safety should be further investigated in a randomized controlled clinical trial.

Pilot study of safety and efficacy of topical liposomal amphotericin B for cutaneous leishmaniasis caused by Leishmania major in Islamic Republic of Iran.

Background: Topical nanoliposomes containing 0.4% amphotericin B (Lip-AmB 0.4%) have shown promising safety results in preclinical and phase 1 clinical trials in healthy volunteers. Aims: To evaluate safety and efficacy of Lip-AmB 0.4% in cutaneous leishmaniasis patients. Methods: Fourteen patients with a total of 84 lesions received national standard treatment of weekly intralesional meglumine antimoniate with biweekly cryotherapy, or daily intramuscular meglumine antimoniate (20 mg/kg/day for 14 days), and topical Lip-AmB 0.4% twice daily for 28 days. Twenty-two patients with a total of 46 lesions (7 at most) were treated with topical Lip-AmB 0.4% alone twice daily for 28 days. Thirty patients with a total of 68 lesions received national standard treatment of weekly intralesional meglumine antimoniate (to blanch around the lesion) and biweekly cryotherapy. Results: Sixty-six patients with cutaneous leishmaniasis lesions completed the study. In the safety evaluation, 2 of the 36 patients evaluated reported a tolerable burning sensation and they preferred to continue treatment. Twelve (92%) of 14 patients with 84 lesions who received national standard treatment combined with Lip-AmB 0.4% completed the study with complete cure. In 1 of the patients with 4 lesions, 1 lesion showed complete cure and 3 showed partial cure. Among 22 patients with 46 lesions who received only topical LipAmB 0.4%, 19 completed the study and 18 showed complete cure (95% efficacy). In the 30 patients who received national standard treatment alone, 33 lesions in 15 patients showed complete cure (48.5%) on day 42 follow-up. Conclusion: Lip-AmB 0.4% alone or in combination with national standard treatment is safe with high-efficacy rate and warrants further investigation during phase 3 clinical trials.