Italian National Registry of Alopecia Areata: an epidemiological study of 699 Italian patients.

BACKGROUND: Alopecia areata (AA) is an organ-specific autoimmune disease that affects the hair follicles of the scalp and the rest of the body causing hair loss. Due to the unpredictable course of AA and the different degrees of severity of hair loss, only a few well-designed clinical studies with a low number of patients are available. Also, there is no specific cure, but topical and systemic anti-inflammatory and immune system suppressant drugs are used for treatment. The need to create a global registry of AA, comparable and reproducible in all countries, has recently emerged. An Italian multicentric electronic registry is proposed as a model to facilitate and guide the recording of epidemiological and clinical data and to monitor the introduction of new therapies in patients with AA. METHODS: The aim of this study was to evaluate the epidemiological data of patients with AA by collecting detailed information on the course of the disease, associated diseases, concomitant and previous events, and the clinical response to traditional treatments. Estimate the impact on the quality of life of patients. RESULTS: The creation of the National Register of AA has proven to be a valid tool for recording, with a standardized approach, epidemiological data, the trend of AA, response to therapies and quality of life. CONCLUSIONS: AA is confirmed as a difficult hair disease to manage due to its unpredictable course and, in most cases, its chronic-relapsing course, capable of having a significant impact on the quality of life of patients.

Circumscribed Morphea of the Scalp: An Entity to Be Considered in the Differential Diagnosis of Cicatricial Alopecia.

Introduction: Morphea, also known as localized scleroderma, could affect the head and neck region, mainly manifesting in a linear pattern. Localized scleroderma of the scalp presenting as a circumscribed alopecic patch has been described as an unusual clinical entity. We present a new case of circumscribed morphea of the scalp. Case Report: We present the case of a 33-year-old man with a single cicatricial alopecic patch of the scalp. The main clinical, trichoscopic, and histopathological findings are described. Conclusion: We suggest considering scalp morphea in the differential diagnosis of mono-lesional cicatricial alopecia involving the scalp.

Remission of Alopecia Universalis after 1 Year of Treatment with Dupilumab in a Patient with Severe Atopic Dermatitis.

Alopecia areata (AA), an autoimmune disease with a relapsing-remitting course, represents the second cause of non-scarring alopecia worldwide and is associated with several comorbidities, notably atopic dermatitis (AD). In particular, AD is related to its more severe forms alopecia totalis (AT) and alopecia universalis (AU) [Nat Rev Dis Primers. 2017;3:17011]. Considering that AA has been classified as T helper 1-driven disease, whereas AD is the prototypical T helper 2 (Th2)-driven skin disorder, recent studies suggest that these forms may underlie a different chemokine expression resulting in a Th2 skewing as a key pathomechanism that could explain this association [JAMA Dermatol. 2015 May;151(5):522-8]. Several reports showed that dupilumab, a fully human monoclonal antibody targeting the interleukin 4α receptor and thus downregulating Th2 response, led to an improvement of AA associated with AD; most of these patients were females with AT or AU, early-onset AD, and atopic comorbidities [Exp Dermatol. 2020 Aug;29(8):726-32]. We report here a case to further support this hypothesis.

Capryloyl glycine and soy isoflavonoids in hypertrichosis: An experimental and placebo-controlled clinical study.

BACKGROUND: The management of acquired hypertrichosis (HT) is based on the search of the causes and subsequent specific treatment. However, simultaneous hair removal is important. No single method for hair removal is appropriate for all patients and skin areas. Treatment options are actually limited and clinical results are often unsatisfactory. Ornithine decarboxylase 1 (ODC1), an enzyme present in hair follicles, is considered as a potential target to inhibit hair growth. Only eflornithine hydrochloride, an inhibitor of ODC1, showed to be partially effective in the management of acquired HT. AIMS: The aim of our study was to evaluate the potential inhibition of ODC1 activity by a cream containing 4% capryloyl glycine, an ODC1 inhibitor, and 1% glycine soy-fermented extract (soy isoflavonoids). Furthermore, we present the results of a placebo-controlled clinical study that evaluated the efficacy and tolerability of this cream. METHODS: The ODC1 activity was detected by measuring absorbance at 340 nm. In the presence of ODC1 inhibitors, absorbance decreases as a function of inhibition. Difluoromethylornithine (DFMO) was provided as an inhibitor control. ODC1 activity inhibition was expressed as percentage of control (untreated sample). All data were presented as mean ± standard deviation of three independent experiments. To determine if statistically significant differences between treatments were present, a t test analysis was performed. The differences between groups were considered significant at p < 0.05. Twelve Caucasian female adult patients, with HT located on the forearms, were enrolled. The study cream (product A) was applied twice/day for four months on the right forearm. A placebo cream (product B) was applied twice/day for four months on the left forearm. Clinical efficacy was evaluated by means of macrophotography. RESULTS: The cream significantly inhibited ODC1 activity (35.1 ± 0.5% inhibition, equivalent to a 64.9 ± 0.5% ODC1 activity). DFMO completely abolished the enzymatic activity (100 ± 5% inhibition, equivalent to 0 ± 5% ODC1 activity). All patients were considered evaluable. In 11 out of 12 patients (91.7%), who were treated with product A, an improvement was observed. No improvement was observed in patients treated with product B. The global assessment showed good efficacy in 7 patients (58.3%) and moderate efficacy in 5 patients (41.7%) treated with the product A. No efficacy was detected in patients treated with product B. CONCLUSIONS: The study cream showed to be effective in Caucasian, adult, female patients with hypertrichosis located on the forearms.

Comparison of clinical and sonographic scores in hidradenitis suppurativa and proposal of a novel ultrasound scoring system.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic, inflammatory disease that presents with nodules, abscesses and fistulae affecting the apocrine gland-bearing skin. Since few years, ultrasonography is used to better characterize HS skin lesions but comparison between clinical and sonographic scores has been made only in small series of patients. To assess concordance between clinical and sonographic scores in a larger cohort of HS patients. METHODS: We conducted a retrospective observational study on 140 HS patients comparing two clinical score systems, Hurley and HS-Physical Global Assessment (PGA), with two ultrasonographic scores, sonographic score of hidradenitis suppurativa (SOS-HS) and ultrasonographic HS-PGA, a novel ultrasound scoring system set up by our group. We used the weighted Cohen's Kappa statistic (k) to evaluate the agreement. RESULTS: Agreement between Hurley staging and SOS-HS was found in 61.4% of patients (weighted kappa 0.477), while agreement between clinical and ultrasonography HS-PGA scores was found in 35% of patients (weighted kappa 0.278), both findings suggesting a substantial disagreement. CONCLUSIONS: Our study demonstrated a relevant disagreement between clinical and ultrasonography scores. Ultrasonography discovered non-clinically evident HS lesions, notably fistulae. Taken together, the above findings may support the view, previously suggested in expert panel reports, on the higher sensitivity of ultrasonography compared to clinics in HS.

Vascularization and fibrosis are important ultrasonographic tools for assessing response to adalimumab in hidradenitis suppurativa: Prospective study of 32 patients.

Hidradenitis suppurativa (HS) is a debilitating skin disease presenting with nodules, abscesses, and fistulae preferentially in the main folds. Adalimumab is the only licensed biologic for moderate-to-severe HS. Ultrasound demonstrated good sensitivity to provide anatomic and functional information in HS; in particular assessing vascularization, related to inflammation, and fibrosis in HS lesions before and after adalimumab treatment with ultrasound and Color Doppler may integrate clinical evaluation with imaging. Patients with moderate-to-severe HS were enrolled in this observational prospective study. Clinical evaluation (according to Hurley classification and International Hidradenitis Suppurativa Severity Score System score) and ultrasound (according to US HS-PGA)/Color Doppler were performed at baseline and after 12 weeks of adalimumab. Ultrasound was used for assessing fibrosis and Color Doppler for vascularization. For each patient, the three most severe lesions among abscesses and fistulae were chosen for total 96 lesions. Thirty-two patients were included, 18 men (56%) and 14 women (44%) with mean age 41.2. Mean IHS4 was 22.4 at baseline and dropped to 14.7 at week 12. Based on US HS-PGA, 14 out of 32 patients fell down by one or more classes of severity. Interestingly, adalimumab led to overall decrease in vascularization, particularly in lesions with intense vascular flow, which were 78 (81.3%) at baseline and became only 25 (26.04%). Finally, marked increase in fibrosis was seen after adalimumab, notably in lesions without fibrosis, which were 81 (84.4%) at baseline and became 15 (15.6%). This study confirms the efficacy of adalimumab in HS and provides value for vascularization and fibrosis as important ultrasonographic tools integrating clinical scores.

Propylene glycol free 5% minoxidil lotion formulation: cosmetic acceptability, local tolerability, clinical efficacy and in-vitro skin absorption evaluations.

BACKGROUND: A new propylene glycol (PG)-free 5% minoxidil (Mnx) lotion has been recently commercialized. Aim of this study was to evaluate the acceptability/tolerability and clinical efficacy of 3-month application of this new PG-free Mnx lotion and the penetration of the active compound in a reconstructed human epidermis (RHE/Episkin) model in comparison with a PG Mnx 5% lotion. METHODS: Thirty subjects of both sex with a diagnosis of AGA were enrolled in the trial. Cosmetic acceptability and clinical efficacy were evaluated after 4, 8 and 12 weeks of treatment. Global tolerability was evaluated at week 12. Cosmetic acceptability evaluation was assessed using a 7-item questionnaire using a 10-point scale score. Global Tolerability was evaluated with a 4-grade scale. Clinical efficacy was evaluated with a 5-grade scale. Skin absorption of PG-free Mnx was evaluated and compared with a PG Mnx solution using the Episkin model. RESULTS: All subjects concluded the study. The 7-item questionnaire mean values were always <2 at each time-point evaluation, demonstrating high cosmetic acceptability/tolerability. No subjects reported burning, itching or redness sensations. Global Tolerability score mean±SD value was 1.7±0.4. Clinical efficacy scores were 0.4, 0.6 and 1.2 at week 4, 8 and 12, respectively. PG-free Mnx showed similar amount of absorbed dose in comparison with PG Mnx. CONCLUSIONS: This new PG-free lotion shows a very good cosmetic acceptability/tolerability profile. Clinical efficacy was also documented. The skin penetration of this formulation is comparable to the PG Mnx lotion, supporting the bioequivalence of the two products.

What Italians think about acne: results of a survey on 2327 acne patients and their mothers.

BACKGROUND: The psychological impact of acne is comparable to that experienced by patients with severe diseases; however, most of the people does not consider acne as a true disease. We evaluated beliefs, sources of information and knowledge about acne in Italian adolescents and their mothers. METHODS: This survey was carried out in 2327 acne patients and their mothers (4654 subjects) by means of a self-administered questionnaire. The questionnaire was based on ten questions: seven questions for the patients and three questions for their mothers. RESULTS: All the 2327 patients and their mothers completed the survey. Approximately 75% of patients declared that acne has a negative influence on their self-esteem and relationships; furthermore, 87% of patients stated that acne limits their social life. Finally, 65% of patients declared that they are under treatment, but only in 20% of cases the treatment was prescribed by a dermatologist. The mothers considered pollution, wrong diet and hyperseborrhea as the most important etiological factors. They considered the treatment suggested by a cosmetologist and contraceptive pill as the best one; only 8% of mothers reported that they regularly took their children to the dermatologist. CONCLUSIONS: In order to improve the treatment and the quality of life in acne patients, there is a need to improve awareness about this disease and its causes and to highlight the role and importance of dermatologists.

Hidradenitis suppurativa/acne inversa: a prospective bacteriological study and review of the literature.

BACKGROUND: Hidradenitis suppurativa is a chronic inflammatory disease of the hair follicle that usually involves specific anatomic areas which are partially occluded, have a higher density of eccrine and apocrine sweat glands and a higher pH. These characteristics could promote the superinfection of certain group of bacteria. We aimed to describe the bacteria that can be isolated from hidradenitis lesions and to establish a correlation between bacteriological results and clinical data. METHODS: We prospectively enrolled forty-six patients presenting purulent or seropurulent discharge. Sixty samples were performed using swabs, which were deeply introduced in the lesions. RESULTS: Fifty-two percent of cultures resulted positive and fifteen bacterial species were isolated. The more prevalent species were Proteus mirabilis and Staphylococcus aureus. Samples from advanced cases were more likely to yield a positive bacterial growth. CONCLUSIONS: In our study the rate of positive cultures increased in more severe stages of the disease, thus bacterial superinfection of established lesions may contribute to maintain chronic inflammation. We could not find statistically significant correlation with the sampled anatomic area or specific group of bacteria. Larger prospective studies should be performed.

Color Doppler as a tool for correlating vascularization and pain in hidradenitis suppurativa lesions.

BACKGROUND: Hidradenitis suppurativa (HS) is a debilitating, chronic-relapsing, inflammatory skin disease of apocrine gland-bearing skin, presenting with nodules, abscesses, and fistulae. Ultrasound is used to classify HS lesions but evaluation of vascularization, related to tissue inflammation, needs Color Doppler. The aim was to correlate vascularization of HS lesions with patients' reported pain. METHODS: Vascularization was assessed with Hitachi Arietta V-70 sonographer according to a four-category system ranging from absent (0), minimal (1), moderate (2) vascularization, and detectable vascular flow (3). Pain was scored with Numeric Rating Scale (NRS) from 0 to 10. RESULTS: Twenty-four patients were included, 13 men (54.2%) and 11 women with mean age of 37.2 (range: 19-61 years). Sixty-nine HS lesions were studied: none of the lesions with absence of vascularization was painful. Lesions with minimal vascularization had a mean NRS value of 3.1 (range: 0 to 7; standard deviation [SD]: 1.6). Lesions with moderate vascularization had a mean NRS value of 6.4 (range: 4-8; SD: 1.4). Lesions with intense vascular flow had a mean NRS value of 7.8 (range: 5-9; SD: 1.7). Correlation Spearman's rank coefficient calculated between the class of vascularization and the mean NRS value was 0.98, supporting high correlation between intensity of vascularization and local pain. CONCLUSION: The present study is the first one demonstrating correlation between vascularization of HS lesions assessed with Color Doppler and local pain. Color Doppler may be a dynamic diagnostic tool that can address the therapeutic approach and assess response to treatment in HS.

Efficacy and tolerability of 1% ciclopirox shampoo in the treatment of moderate-to-severe scalp seborrheic dermatitis: a multicenter, prospective, assessor-blinded trial.

BACKGROUND: Seborrheic dermatitis (SD) is a very common inflammatory skin disease. It occurs in 1-3% of the population. The most supported pathogenetic theory links SD to dandruff via a common etiology, yeasts of the genus Malassezia. Ketoconazole and ciclopirox (CPX) shampoo are considered as the first line treatment of SD of the scalp. CPX is a broad-spectrum, hydroxypyridone-derived, synthetic antifungal agent with anti-bacterial, anti-inflammatory, and anti-oxidant properties. The aim of this study was to assess the efficacy and tolerability of 1% CPX shampoo in SD of the scalp. METHODS: A total of 40 patients, 31 men and 9 women, mean age 33±6 years, with scalp SD of moderate-to-severe grade were enrolled, after their informed consent, in this 12-week prospective assessor-blinded trial. One-percent CPX shampoo (5 mL) was applied twice a week for 12 weeks. The primary efficacy parameter was the Total Dandruff Severity Score (TDSS), based on 4-point ordinal scales describing signs and symptoms (scaling, inflammation, and itching) of the disease, evaluated in an assessor-blinded fashion, at baseline and after 6 and 12 weeks. Secondary outcomes were the single items of the TDSS and the evaluation of local tolerability. RESULTS: At baseline the TDSS was 17±5. After 1% CPX TDSS was reduced to 10±5 at week 6 and to 6.6±4 at the end of study period (P=0.0001; ANOVA test). This difference represents a 62% reduction in comparison with baseline. At week 12, the reduction of scaling, inflammation and itching scores were -55%, -65%, and -69%, respectively. The product was very well tolerated. No side effects were reported or observed during the study. CONCLUSIONS: The study supports the use of 1% CPX shampoo in the treatment of SD of the scalp. CPX shampoo was able to reduce desquamation, inflammation and itching associated with scalp SD. Furthermore, 1% CPX shampoo was found to be safe and well tolerated.

The use of minoxidil in the treatment of male and female androgenetic alopecia: a story of more than 30 years.

Even if minoxidil has been known for over 30 years as "hair growth stimulator" the precise mechanism of its action is not completely elucitated. Minoxidil shortens telogen, accelerates telogen-exogen phase and causes the premature entry of resting hair follicles into anagen phase. Moreover, minoxidil increases hair follicle size. A large part of hair treatment scientific literature confirms the efficacy of topically applied minoxidil in humans. In particular, patients treated with minoxidil showed a significant increase in "non vellus" hair count starting from baseline. Preparation of minoxidil requires molecule stability and solubility. Today are available on the market minoxidil-based formulations having low-concentration of propylene glycol to obtain preparations with a better cosmetical acceptance and dermatological safety. The body of evidences indicates that minoxidil still represent a milestone in the treatment of androgenetic alopecia and that its story is going on.

Acneiform eruptions caused by vitamin B12: A report of five cases and review of the literature.

We describe five cases of acneiform eruption caused by vitamin B12 in five females aged 37, 32, 62, 29, and 21 years, respectively. The eruption appeared from 1 week to 5 months after the beginning of the therapy with i.m. or oral vitamin B12. Clinical picture was characterized by papules and pustules located on the face. In three patients, similar lesions were also present on the neck, shoulders, chest, and upper portion of the back. Comedones and cysts were absent. In two patients, serum vitamin B12 levels were very high. Histopathologic examination in one patient revealed an eosinophilic folliculitis. Spontaneous and complete remission was observed in all patients 3-6 weeks after vitamin B12 discontinuation.

Are topical retinoids teratogenic?

Retinoic acid is a physiological compound of human blood. Blood levels range from 1000 to 7000 pg/mL (usually 1500-5000 pg/mL). Results of studies on absorption of topical retinoic acid in laboratory animals, although rather conflicting, demonstrate that it induces plasma concentrations which are well below concentrations caused by non-teratogenic oral doses. In humans, minimal percutaneous absorption of tretinoin was observed after topical applications. Neither single dose nor long-term treatment with topical tretinoin affect the endogenous levels of retinoic acid or its metabolites. Topical application of tretinoin at doses used in acne unlikely induces systemic effects. Although some clinical cases of suspected tretinoin-related embryotoxicity have been described, three prospective cohort studies clearly demonstrated the safety of topical tretinoin as an embryotoxic agent.