Triple-combination clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel for moderate-to-severe acne in children and adolescents: Randomized phase 2 study.

BACKGROUND/OBJECTIVES: Topical clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel (IDP-126) is the first fixed-dose triple-combination formulation in development for acne. This post hoc analysis investigated efficacy and safety of IDP-126 in children and adolescents with moderate-to-severe acne. METHODS: In a randomized, double-blind phase 2 study (NCT03170388), participants ≥9 years of age with moderate-to-severe acne were eligible for randomization (1:1:1:1:1) to once-daily IDP-126, one of three dyad combination gels, or vehicle gel for 12 weeks. This post hoc analysis of pediatric participants (n = 394) included children and adolescents up to 17 years of age. Assessments included treatment success, inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability. RESULTS: At Week 12, treatment success rates were significantly greater with IDP-126 (55.8%) than with vehicle (5.7%; p < .001) or any of the dyad combinations (range: 30.8%-33.9%; p < .01, all). Lesion reductions with IDP-126 were also significantly greater than with vehicle (inflammatory: 78.3% vs. 45.1%; noninflammatory: 70.0% vs. 37.6%; p < .001, both) and 9.2%-16.6% greater than with any of the dyad combinations. Increases (improvements) from baseline in Acne-QoL domain scores were generally greater with IDP-126 than in any other treatment group. The most common treatment-related TEAEs across treatment groups were application site pain and dryness. Most treatment-related TEAEs were of mild-to-moderate severity. CONCLUSION: IDP-126 gel-a novel fixed-dose, triple-combination topical formulation for acne-demonstrated superior efficacy to vehicle and three dyad component gels and was well tolerated in children and adolescents with moderate-to-severe acne.

Characterization of wound microbes in epidermolysis bullosa: A focus on Pseudomonas aeruginosa.

The most common bacteria isolated from wound cultures in patients recorded in the Epidermolysis Bullosa Clinical Characterization and Outcomes Database (EBCCOD) are Staphylococcus aureus and Pseudomonas aeruginosa. Given the prevalence of P. aeruginosa in this patient population and prior research implicating P. aeruginosa's potential role in carcinogenesis, we sought to further analyze patients with recorded wound cultures positive for Pseudomonas aeruginosa in the EBCCOD. We provide a descriptive analysis of this subset of patients and highlight potential avenues for future longitudinal studies that may have significant implications in our wound care management for patients with epidermolysis bullosa.

Comparison of sulfur ointment and permethrin treatments in scabies.

Scabies is a contagious, parasitic skin disease that adversely affects the quality of life and, can cause systemic complications if it is not properly treated. Sulfur ointment and permethrin cream are among the most used topical agents in the treatment of scabies. In this study, we aimed to compare the efficacy of sulfur ointment and permethrin cream in the treatment of scabies. In this single-center study, patients who were diagnosed with scabies in the dermatology outpatient clinics of Karabuk University Training and Research Hospital between April, 2021 and September, 2021 were investigated retrospectively. Age, gender, date of diagnosis, topical agent used for scabies treatment, and response to the treatment at the control examination in the second week were recorded. The patients were divided into two groups those receiving 5% permethrin cream or 10% sulfur ointment, and the treatment efficacy of both agents was compared. This study showed that 10% sulfur ointment was significantly more effective in treating scabies than 5% permethrin cream (p < 0.001). Moreover, younger patients with scabies responded better to both treatments. 10% Sulfur ointment can be considered a safe and effective topical option in the treatment of scabies. The resistance to 5% permethrin cream, which is the most commonly used agent for scabies, can be a concern as an unexpected low success rate was obtained in this study.

Topical calcipotriol combined with urea 20% versus intralesional injection of triamcinolone acetonide, 5-fluorouracil, and methotrexate in the treatment of nail psoriasis: A comparative study.

There is no consistently effective treatment for psoriatic nails. Topical and intralesional modalities have been recently investigated and showed promising efficacy and safety. To compare the efficacy and safety of intralesional injection of 5-fluorouracil (5-FU), methotrexate (MTX), triamcinolone acetonide (TA) versus topical calcipotriol plus urea 20% in the treatment of nail psoriasis. This study included 60 patients with nail psoriasis who were randomly assigned to 4 groups, each containing 15 patients. The first 3 groups received intralesional injection of 0.1 ml of 5-FU (group A), MTX (group B), and TA (group C) into the nail matrix and bed monthly for 3 months. Group D received a topical combination of calcipotriol/urea 20% twice daily for 3 months. Therapeutic response was assessed every month for 3 months using the target nail psoriasis severity index (NAPSI). The mean percentage of improvement was significantly higher in topical calcipotriol/urea combination (57.1 ± 26.4) than intralesional TA (44.2 ± 32.7), intralesional MTX (37.7 ± 14.2), and intralesional 5-FU (29.6 ± 14). Adverse effects were mild and insignificant in the studied groups. Topical calcipotriol/urea combination seems to be more effective and safe than intralesional injections of 5-FU, MTX, and TA.

Intralesional full-concentration (25 mg/ml) methotrexate in the treatment of plantar warts: A pilot study.

Plantar warts continue to represent a therapeutic challenge due to treatment resistance and high recurrence rates. Intralesional methotrexate, a cytotoxic chemotherapeutic agent with in-vitro anti-viral properties has been used for many dermatological indications. Two previous studies evaluated intralesional injection of diluted methotrexate (in 0.5, 1, and 2 mg/ml dilutions) in the treatment of warts and found it poorly effective. The concentrations used in these studies were much lower than those used for other indications. The current, open-label, prospective, pilot study aimed to evaluate the safety and efficacy of the intralesional injection of full concentration (25 mg/ml) methotrexate in the treatment of plantar warts. Twenty patients with plantar warts, 10 (50%) males, and 10 (50%) females, with mean ± SD age of 28.45 ± 8.66 years (range, 18-46 years) received biweekly sessions of intralesional methotrexate (25 mg/ml) until complete clearance or for a maximum of 6 sessions. Complete clearance of warts was achieved in 2 (10%), 6 (30%), and 7 (35%) patients after 4, 5, and 6 sessions, respectively. Another 8 (40%) patients showed partial improvement after 6 sessions. The response rate did not correlate significantly with the number of warts. Nine (45%) patients did not report any side effects. Pain and bruises were reported by 8 (40%) and 6 (30%) patients, respectively. These findings suggest that biweekly sessions of full (25 mg/ml) concentration of methotrexate are a safe and effective treatment for plantar warts. It may be considered an alternative line of treatment for resistant cases.

Imiquimod-enhanced immunotherapy with diphencyprone for patients with alopecia areata.

Topical immunotherapy with dyphencyprone (DPCP) is widely used in patients with alopecia areata (AA). It can produce a contact dermatitis that is believed to decrease Th1 response, predominant in AA. It has been shown that imiquimod (IMQ), a topical immunomodulator drug, can produce sensitization to DPCP in patients that do not show signs of contact dermatitis when exposed to DPCP. Nevertheless, there is no evidence as to whether it can improve DPCP efficacy in already sensitized patients. We present a series of 9 patients, (7 females [77%] and 2 males [22%]) with a mean age of 38.4 years (range, 19-60 years), successfully sensitized to DPCP, that were treated with a combination of DPCP and IMQ. The mean SALT (Severity of Alopecia Tool) score before adding IMQ was 43.3 (range, 10-60), and the mean number of months of DPCP use prior to the addition of IMQ was 6.8 (range 0-10). After adding IMQ to their DPCP treatment, 77% of the patients had further improvement, with a mean SALT reduction of 13.3 (range, [-50] - 40), and a mean duration of response of 5.2 months. No adverse effects were reported. According to this data, we believe that the combination of DPCP and IMQ can be a promising way of improving the efficacy of contact immunotherapy in AA, and requires further study.

Patient satisfaction with calcipotriol/betamethasone dipropionate cutaneous foam for the treatment of plaque psoriasis: The LION real-life multicenter prospective observational cohort study.

Topical treatment is the mainstay for mild or moderate psoriasis, but patients are generally little satisfied. Calcipotriol/betamethasone dipropionate (Cal/BD) cutaneous foam has shown to improve signs and symptoms in plaque psoriasis patients. This study assessed patient's satisfaction with Cal/BD foam in a real-life Italian dermatological clinical practice. A multicenter, 4-week observational prospective cohort study enrolled, in 17 Italian dermatology clinics, adult patients with plaque psoriasis on the body and/or scalp. Treatment satisfaction was assessed by 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9), preference over previous treatments by Patient Preference Questionnaire (PPQ), and change in disease state by Psoriasis Area Severity Index (PASI). Overall 256 patients were eligible, with a mean (SD) age of 55.6 (15.4) years, 59.4% were males. Psoriasis severity was mild in 52.0% of patients, moderate in 43.3%, and severe in 4.7%. Scalp involvement was present in 36.7% of patients. Previous antipsoriatic treatments had been received by 80.5% of patients. TSQM-9 median (25th-75th percentile) scores were 83.3 (66.7-88.9) for effectiveness, 77.8 (66.7-88.9) for convenience, and 78.6 (64.3-92.9) for global satisfaction. Mean (SD) PASI value decreased from 7.3 (4.8) to 2.1 (2.7) after 4 weeks. More than 90% of patients previously treated for psoriasis evaluated the Cal/BD foam more effective, easier to use and better tolerated compared to previous topical treatments at PPQ. This observational study provides real-life evidence of a high level of satisfaction with effectiveness and convenience of the Cal/BD foam in a cohort of plaque psoriasis patients, with an objective improvement in PASI.

Erythema-directed digital photography and colorimeter scores correlate with rosacea erythema evaluation in patients under treatment with topical ivermectin.

Inflammatory rosacea is clinically characterized by persistent erythema and inflammatory lesions. Its severity is generally based on clinical observation that may be cumbersome. The aim of this study was to assess if erythema-directed digital photography (EEDP) and colorimeter (COL) correlate and are concordant with clinical evaluation of erythema degree of rosacea under topical treatment. Thirty naïve patients with mild/moderate inflammatory rosacea were instructed to apply ivermectin cream for 8 weeks. Erythema degree was performed at baseline, and at 2, 4, 6, and 8 weeks by clinician erythema assessment based on 5-point severity scale (from 0 = no erythema to 4 = fiery redness), and by instrumental evaluation by EDDP using the same 5-point scale of clinical assessment and by COL using a 5-point scale (from 0 = <1 units = no erythema to 4 > 12 units = fiery redness). Concordance and correlation analysis were performed using Cohen's Kappa coefficient and Correlation Coefficient test respectively. At baseline a statistically significant concordance/correlation value between EDDP and COL was observed. At 2 weeks, the statistical concordance/correlation value between instrumentals were both increased, along with a slight significant concordance between clinical assessment and erythema-directed digital photography. At 4, 6 and 8 weeks, a statistically significant increase of concordance/correlation value among all the considered parameters from baseline was found. The results of our study showed that at baseline and during the early treatment stage both EDDP and COL were able to appreciate more accurately the erythema grade compared to clinical observation supporting the use of non-invasive techniques for a more objective evaluation of erythema in rosacea.

Pregnancy and breastfeeding in hidradenitis suppurativa: A review of medication safety.

Hidradenitis suppurativa (HS) is a chronic inflammatory disease that disproportionately affects women of childbearing age. Pregnancy influences HS severity for many women, thus diligent continued management throughout pregnancy and postpartum may be required. Herein, we provide an updated review of pregnancy and lactation safety data for HS medications, including topical antiseptic washes, topical and systemic antibiotics, biologic and nonbiologic immunomodulators, immunosuppressants, adjunct medical therapies, and pain medications, to help guide risk-benefit discussions between providers and HS patients.

Topical beta-blockers in dermatologic therapy.

An increasing use of beta-blockers in dermatology has been described over the last 10 years, despite the fact that their use in diseases other than infantile hemangiomas is off-label. This review discusses the emerging role of topical beta-blockers in the treatment of infantile hemangioma, but also pyogenic granuloma, Kaposi sarcoma, wounds and nail paronychia. Data in literature demonstrate that topical beta-blockers are a safe and valid therapeutic option in numerous cutaneous diseases. Side effects are mainly restricted to the application site. Further studies and randomized trials may contribute to reinforce the role of topical beta-blockers in the dermatological armamentarium.

Comparison of effectiveness of topical tacrolimus 0.1% vs topical halobetasol propionate 0.05% as an add-on to oral hydroxychloroquine in discoid lupus erythematosus.

In recent years, calcineurin inhibitors have been used as the first line alternative to topical corticosteroids in the treatment of discoid lupus erythematosus (DLE). We aim to evaluate the efficacy and safety of topical tacrolimus 0.1% vs topical halobetasol propionate 0.05% in patients with DLE. This comparative study was carried out in the Department of Dermatology and Venereology, Chittagong Medical College Hospital (CMCH), Bangladesh between the period of July 2018 and June 2019. The change of DLE activity assessed with the cutaneous lupus erythematosus disease area and severity index was used as a primary outcome measure. The effective sample was 40 patients in each group. Both groups were similar in terms of baseline demographic and clinical characteristics. After 8 weeks of treatment, the mean total erythema score decreased significantly in both groups (in tacrolimus treated group [TTG] from 12.53 ± 8.05 to 8.03 ± 5.69, [P < .001] and in halobetasol propionate treated group [HTG] from 11.83 ± 7.17 to 7.30 ± 4.56 [P < .001]), as well as the mean total scale/hypertrophy score (in TTG from 8.08 ± 5.30 to 4.33 ± 3.21; [P < .001] and in HTG from 7.40 ± 4.73 to 3.68 ± 2.01, [P < .001]. The magnitude of reduction was significantly better in HTG [P = .032]). The mean total activity score decreased significantly in both groups (in TTG from 22.95 ± 13.40 to 14.33 ± 8.89, [P < .001] and in HTG from 22.15 ± 11.95 to 13.7 ± 7.22, [P < .001]). The present study demonstrated that tacrolimus 0.1% ointment and halobetasol propionate 0.05% ointment had a comparable efficacy in DLE patients; however, halobetasol showed significantly better improvement regarding scaly, hypertrophic lesions.

Outcomes and adverse effects of ablative vs nonablative lasers for skin resurfacing: A systematic review of 1093 patients.

It is generally believed that ablative laser therapies result in prolonged healing and greater adverse events when compared with nonablative lasers for skin resurfacing. To evaluate the efficacy of ablative laser use for skin resurfacing and adverse events as a consequence of treatment in comparison to other modalities, a PRISMA-compliant systematic review (Systematic Review Registration Number: 204016) of twelve electronic databases was conducted for the terms "ablative laser" and "skin resurfacing" from March 2002 until July 2020. Studies included meta-analyses, randomized control trials, cohort studies, and case reports to facilitate evaluation of the data. All articles were evaluated for bias. The search strategy produced 34 studies. Of 1093 patients included in the studies of interest, adverse events were reported in a total of 106 patients (9.7%). Higher rates of adverse events were described in nonablative therapies (12.2% ± 2.19%, 31 events) when compared with ablative therapy (8.28% ± 2.46%, 81 events). 147 patients (13.4%) reported no side effects, 68 (6.22%) reported expected, transient self-resolving events, and five (0.046%) presented with hypertrophic scarring. Excluding transient events, ablative lasers had fewer complications overall when compared with nonablative lasers (2.56% ± 2.19% vs 7.48% ± 3.29%). This systematic review suggests ablative laser use for skin resurfacing is a safe and effective modality to treat a range of pathologies from photodamage and acne scars to hidradenitis suppurativa and posttraumatic scarring from basal cell carcinoma excision. Further studies are needed, but these results suggest that ablative lasers are a superior, safe, and effective modality to treat damaged skin.

Primary cutaneous lymphomas in children: A prospective study from the Spanish Academy of Dermatology and Venereology (AEDV) Primary Cutaneous Lymphoma Registry.

BACKGROUND/OBJECTIVES: Primary cutaneous lymphomas are rare in pediatric patients. The clinical and histopathological manifestations may differ from those in adults. Due to their low frequency and the insidious clinical picture, the diagnosis is usually delayed. The Spanish Primary Cutaneous Lymphoma Registry was initiated in 2016 as a multicenter registry that would allow better insight into the epidemiological, clinical, histopathological, and treatment response characteristics of patients with primary cutaneous lymphomas. METHODS: We conducted a prospective observational cohort study of primary cutaneous lymphomas in pediatric patients participating in the Spanish Academy of Dermatology and Venereology (AEDV) Primary Cutaneous Lymphoma Registry. RESULTS: At the time of the analysis, 10 patients under 18 years of age out of 799 all-age cases (1.25%) had been included in the registry (7 males, 3 females). The mean age at diagnosis was 9.7 years (SD: 4.8). Seven (70%) had mycosis fungoides, 2 of them had the folliculotropic variant; and 3 (30%) had primary cutaneous marginal zone B-cell lymphoma. CONCLUSIONS: Primary cutaneous lymphomas are extremely rare in pediatric patients and usually have a good prognosis. Therefore, a high level of suspicion is necessary for the diagnosis. We suggest management by experienced physicians and follow-up into adulthood.

Clinical characteristics and management of clinically amyopathic juvenile dermatomyositis across four academic centers.

BACKGROUND/OBJECTIVES: Clinically amyopathic juvenile dermatomyositis (CAJDM) is an uncommon but important subset of patients with juvenile dermatomyositis, characterized by pathognomonic cutaneous findings without clinically evident muscle weakness. With limited data available and lack of standardized management guidelines for CAJDM, we sought to describe common features, including early indicators that may be associated with progression of muscle disease, and review the course and treatment of these patients. METHODS: A retrospective chart review of patients with CAJDM was conducted at four North American academic centers between the years 2000 and 2015. RESULTS: Twenty-nine patients were included, of whom 21 (72%) were female. After a median follow-up of 4 years (IQR 1.8-5.8 years), 5 of the 29 (17%) patients with CAJDM evolved into classic juvenile dermatomyositis. Median time to develop weakness was 12 months (IQR 8-19 months) after diagnosis. The skin disease of CAJDM patients who did not develop weakness was often found to be recalcitrant with 58% of them requiring multiple systemic therapies to control their cutaneous disease. CONCLUSION: These results highlight the need for long-term monitoring for the development of myositis in CAJDM and for prospective studies on treatment of recalcitrant skin disease.

Efficacy and safety of a new formulation kit (shampoo + lotion) containing anti-inflammatory and antioxidant agents to treat hair loss.

Androgenetic alopecia (AGA) and telogen effluvium (TE) are common causes of hair loss, with limited options for treatment. The aim of this study was to determine the efficacy and safety of a new formulation kit (Pielus Anti-hair loss lotion and shampoo) containing anti-inflammatory and antioxidant agents in patients with TE and/or AGA. This was a prospective, single-arm, open-label study with 35 women and 10 men, median age of 44 years, with clinical diagnosis of TE and/or AGA. They used the combination of shampoo and lotion daily for 90 days. There was nonoccurrence of adverse events. Phototricogram showed increase in the average number of anagen hairs at T90 (P < .001). Scalp microphotography showed increase in total follicular units, total of hairs, and median hair per follicle unit at T90. There was an increase in diameter (P = .003) and in median maximum load and resistance to traction in T90 (P = .040). Combing and washing test demonstrated a decrease in the number of shed hairs before washing (P = .005), after washing (P = .01) and in total (P < .001). The use of shampoo+ lotion daily was safe and effective to attenuate hair loss in men and women with TE and/or AGA.

Topical sirolimus for treatment of a solitary angiokeratoma.

Angiokeratomas are benign vascular neoplasms that arise as solitary or multiple lesions, most commonly treated with excision, electrodessication, cryotherapy, or laser therapies. This case presents a young female whose solitary angiokeratoma was treated with topical 1% sirolimus cream, improving the appearance, symptoms, and size of the lesion. Topical sirolimus cream may be a noninvasive treatment option for angiokeratomas with fewer risks than standard therapy that may be feasible and preferable for some patients.

COVID-19 with dermatologic manifestations and implications: An unfolding conundrum.

The novel coronavirus SARS-CoV-2 has caused Coronavirus Disease 2019, widely known as COVID-19, now a pandemic with extraordinary infectivity, mortality, and fomite adhesiveness. We delineate cutaneous manifestations of COVID-19, some of which may represent adverse cutaneous drug reactions, and skin changes associated with COVID-19 lifestyle alterations in patients and health care workers. We review COVID-19 from both a dermatologic and public health perspective.

Female pattern hair loss: A comprehensive review.

Female pattern hair loss is a common form of hair loss in women that increases in incidence with age. The etiology is unknown with numerous factors identified that influence its onset. Female pattern hair loss may be viewed as a marker for an increased risk of cardiovascular and metabolic disease. New treatments include microneedling, low-level laser therapy, and autologous fat transfer. This article focuses on the pathophysiology, diagnosis, systemic associations, and current treatments for female pattern hair loss, which is the most common cause of alopecia in women.

Topical cidofovir for the treatment of recalcitrant viral warts and molluscum contagiosum in Jacobsen syndrome.

Jacobsen syndrome is caused by a terminal deletion on the long arm of chromosome 11 and can be associated with immunodeficiency. Patients with Jacobsen syndrome can be predisposed to cutaneous viral infections that are difficult to treat. We report successful use of topical 1% cidofovir as treatment of recalcitrant verruca vulgaris in one patient and molluscum contagiosum in another patient with Jacobsen syndrome. Topical cidofovir appears to be a good treatment option in this cohort and should be considered early for treatment-resistant cutaneous viral infections.

Improvement in disease severity and pruritus outcomes with crisaborole ointment, 2%, by baseline atopic dermatitis severity in children and adolescents with mild-to-moderate atopic dermatitis.

BACKGROUND/OBJECTIVES: Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis (AD). This pooled post hoc analysis of two phase 3 trials (NCT02118766, NCT02118792) assessed improvement and time to improvement in Investigator's Static Global Assessment (ISGA) and Severity of Pruritus Scale (SPS) outcomes in pediatric patients with mild-to-moderate AD. METHODS: Patients aged ≥2 years were randomly assigned 2:1 to receive twice-daily crisaborole or vehicle for 28 days. Patients aged 2-17 years were pooled for this analysis. Proportions of patients and time to achieving ISGA success (clear [0] or almost clear [1] with ≥2-grade improvement from baseline), ISGA clear/almost clear, ≥1-grade improvement in ISGA, SPS success (SPS score ≤1 with ≥1-grade improvement), or ≥1-grade improvement in SPS score were analyzed and stratified by baseline ISGA. RESULTS: At first postbaseline assessment (day 8), significantly higher proportions of crisaborole- than vehicle-treated patients achieved ISGA success, ISGA clear/almost clear, ≥1-grade ISGA improvement, SPS success, or ≥1-grade improvement in SPS regardless of baseline ISGA. Differences were significantly greater over time for all outcomes for patients with moderate baseline ISGA and numerically greater for those with mild baseline ISGA. Median times to ISGA and SPS outcomes were shorter for crisaborole versus vehicle. CONCLUSION: Improvement in ISGA and SPS outcomes were observed with crisaborole in pediatric patients with mild-to-moderate baseline AD.