Joseph F. Fowler Jr. MD FAAD
Colloidal oatmeal suspensions are currently available in bath soaps, shampoos, shaving gels, and moisturizing creams, and several studies have been conducted that demonstrate the efficacy and safety of colloidal oatmeal for the treatment of inflammatory skin conditions. The diverse chemical polymorphism of oats translates into numerous clinical utilities for atopic dermatitis (AD) and eczema. Avenanthramides are the principle polyphenolic antioxidants in oats, and they have been shown to assuage inflammation in murine models of contact hypersensitivity and neurogenic inflammation and also reduce pruritogen-induced scratching in a murine itch model. Moreover, avenanthramides are a potent antioxidant. This paper will discuss various studies that have found colloidal oatmeal compounds to be beneficial in the treatment of AD and also as adjunctive treatments for AD.
J Drugs Dermatol. 2014;13(10):1180-1183.
Tracey C. Vlahovic DPMa and Warren S. Joseph DPM FIDSAb
OBJECTIVE: To evaluate efficacy, safety, and tolerability efinaconazole topical solution, 10% in diabetic patients with onychomycosis
METHODS: A post-hoc analysis of 112 patients, aged 29-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at week 52.
RESULTS: Mycologic cure rates (OC) were significantly greater with efinaconazole (56.5% and 56.3% in diabetic and non-diabetic patients respectively) compared to vehicle (P=0.016 and P<0.001, respectively). The primary end point, complete cure, was also greater for efinaconazole (13.0% and 18.8%, respectively vs 3.7% and 4.7%). Treatment success (percent affected target toenail ≤10%) for efinaconazole was 40.8% and 47.7%, respectively vs 18.5% and 18.2% with vehicle. There was no statistically significant difference between the diabetic and non-diabetic populations for any efficacy endpoint. Adverse events associated with efinaconazole were local site reactions and clinically similar to vehicle.
CONCLUSIONS: Once daily efinaconazole topical solution, 10% may provide a useful topical option in the treatment of diabetic patients with onychomycosis.
J Drugs Dermatol. 2014;13(10):1186-1190.
Georgia Schuller-Levis MD,a William Levis MD,b and Israel Dvoretzkyc
Prior studies have identified local heat therapy as a treatment for recalcitrant warts. We have employed a thermal pad that raises local temperature to 42-43ºC for at least 2 hours in a proof of concept study of three patients with recalcitrant warts. The recalcitrant warts cleared in all three patients beginning in the fourth and fifth weeks after daily treatment with the pads. There were no adverse events. We conclude that the timing of clearance following use of these thermal pads is likely via direct viral killing and immunologic mechanisms. Further controlled trials are underway.
J Drugs Dermatol. 2014;13(10):1194-1196.
Joseph F. Fowler MD,a Ole Graff MD,b Abbas G. Hamedanib
Severe chronic hand eczema (sCHE) is a persistent, disfiguring disease that responds poorly to conventional treatment and causes substantial physical and psychological disability. The objective of this study was to evaluate efficacy and safety of oral alitretinoin in sCHE in a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing alitretinoin with placebo. Efficacy was assessed every 4 weeks during treatment and 4 weeks after end of treatment (EOT, 24 weeks); responders were assessed every 4 weeks for a further 48 weeks after EOT. The study was conducted at academic and private dermatology centers. The participants were 596 patients with sCHE refractory to potent topical corticosteroids. Patients were treated with daily oral alitretinoin 30 mg or placebo for up to 24 weeks. Primary endpoint was proportion of responding patients based on Physician Global Assessment (PGA) of “clear” or “almost clear” at EOT. Key secondary endpoints: Patient Global Assessment (PaGA), change in modified Total Lesion Symptom Score (mTLSS), time to response (TTR), extent of disease at EOT, and duration of response (DOR). At EOT, 40% of alitretinoin-treated patients were responders vs 15% placebo-treated patients (odds ratio [OR] = 3.78; P < .001); a greater proportion of alitretinoin-treated patients achieved a PaGA of “cleared” or “almost cleared” (OR = 4.05; P < .001). A greater decrease in mTLSS occurred from baseline to EOT in alitretinoin- vs placebo-treated patients (treatment difference −24% P < .001). Median TTR for responders at EOT was shorter with alitretinoin vs placebo (65 vs 117 days; P < .001). Greater decreases in extent of disease at EOT were observed with alitretinoin vs placebo (treatment difference −22%; P < .001). The most common treatment-emergent adverse event was headache. Alitretinoin significantly improved signs/symptoms of sCHE, was well tolerated in patients refractory to potent topical corticosteroids, and may provide benefit to this population.
J Drugs Dermatol. 2014;13(10):1198-1204.
Leslie Baumann MD,a Deysi K. Duque MS,a and Michael J. Schirripa PhDb
BACKGROUND: Vitamin C is commonly used to treat aged skin. It has shown regenerative effects on skin wrinkles, texture, strength, and evenness of tone through its roles as an antioxidant, tyrosinase inhibitor, and inducer of collagen synthesis. Available vitamin C formulations on the anti-aging skin care market vary by their pH, packaging, and vehicle, which may decrease absorption, and therefore, the efficacy of the product.
OBJECTIVE: The purpose of this study was to assess the subjective efficacy, wearability, tolerance and overall preference of two professional vitamin C topical serums and sunscreens in Caucasian females using a split face method.
METHODS: A virtual split-face study of 39 Caucasian women compared two popular vitamin C and SPF product combinations – C-ESTA® Face Serum and Marini Physical Protectant SPF 45 (Jan Marini Skin, San Jose, CA; Products A) and CE Ferulic® and Physical Fusion UV Defense SPF 50 (Products B; SkinCeuticals Inc, Garland, TX). The products were assigned to each subject’s left or right side of the face, and subjects rated and compared products through 5 online surveys at baseline, 24 hours, days 3, 7, and 14.
RESULTS: Over 86% of the 35 subjects who completed the study preferred the smell and 83% preferred the feel and application of vitamin C Serum A over Serum B. Seventy-one percent of subjects preferred the feel and application of Sunscreen A over Sunscreen B. Results also showed a significant skin texture improvement and skin tone with Products A vs Product B. Products A trended higher for multiple additional categories.
CONCLUSIONS: Products A exhibited superior anti-aging benefits than Products B. Subjects preferred the smell, feel, and application of Products A and experienced significantly less irritation than Products B. Overall, Products A were preferred over Products B with subjects willing to pay more for Products A over Products B.
J Drugs Dermatol. 2014;13(10):1208-1213.
Karen E. Burke,a Xueyan Zhou,a Yongyin Wang,f Joel Commisso,b Carl L. Keenb
Robert M. Nakamura,a Gerald F. Combs Jr.,d and Huachen Weia,e
Previous studies in mice have shown that topical L-selenomethionine (SeMet) can prevent UVB-induced skin cancer when applied continuously before, during, and after the radiation exposure. With topical application of SeMet, selenium levels were shown to increase in the skin and liver, as well as in tumor tissue. Thus, possibly, the timing of SeMet application could affect the degree of inhibition of UVB-tumorigenesis (or maybe even enhance tumorigenesis at some stage). The goal of this research was to determine whether topical SeMet best inhibits UV-induced skin cancer if (a) begun before and continued during and after UVB exposure, (b) if begun before UVB-exposure and discontinued when tumors are first clinically detected, or (c) if begun only after tumors are first detected and continued thereafter. Groups of ten Skh: 1 hairless, non-pigmented mice were treated topically with vehicle lotion, or with SeMet (0.05%) in that vehicle lotion applied either (a) before, during, and after UV exposure, (b) before UV radiation and continued only until the first tumor was detected, or (c) only after the first tumor was detected. In all cases, UV irradiation was discontinued at the time of detection of the first tumor. Optimal inhibition of skin cancer was achieved by application of topical SeMet before, during, and after exposure; significant protection was also attained with application only after the onset of tumors. Notably, statistically significant protection was not seen with SeMet application only prior to tumor detection. These results suggest that even beginning SeMet supplementation late in the process of tumorigenesis can help protect from UV-induced photodamage and skin cancer.
J Drugs Dermatol. 2014;13(10):1214-1223.
Sahar Y. Naseer MS,a Liza Gill BS,b Jay Shah MD,b and Animesh A. Sinha MD PhDa
Pemphigus vulgaris is a chronic autoimmune blistering disorder of the skin. As with many autoimmune diseases, a female predominance in pemphigus vulgaris is well established. The genetic and physiological basis for this gender bias is not well understood. Moreover, it is unclear whether the affect of gender extends beyond disease susceptibility to influence disease presentation. To address this issue, we performed a comprehensive analysis of 72 male and 125 female pemphigus vulgaris patients across a set of defined demographic (HLA type, ethnicity) and clinical (age at disease onset, anti-desmoglein antibody levels, site of lesions, and history of autoimmune disease) factors. We find that male patients are more likely to present with disease onset before age 40 than females. Additionally, we find that males have increased cutaneous involvement and display greater co-expression of anti-Dsg1 and anti-Dsg3 antibodies, while females tend to have mucosal predominance and stronger personal and family histories of autoimmunity. We do not find any differences in the distribution of HLA type or ethnicity between male and female pemphigus vulgaris patients. Our findings establish that gender does influence disease presentation in pemphigus vulgaris, supporting a role for genetic and hormonal factors in immune dysregulation and perpetuation of the autoimmune phenotype.
J Drugs Dermatol. 2014;13(10):1225-1230.
Julian Mackay-Wiggan MD MS,a Jackleen Marji MD PhD,a John G. Walt MBA,b Angela Campbell,a Carol
Coppola,a Bibhas Chakraborty PhD,c David A. Hollander MD MBA,b and Scott M. Whitcup MDb
BACKGROUND: Limited options are available for the treatment of brittle nail syndrome.
OBJECTIVE: To assess the efficacy and safety of topical cyclosporine emulsion (CsAE) versus emulsion (vehicle) alone in the treatment of brittle nail syndrome.
RESULTS: Twenty-four patients were randomized to topical CsAE emulsion or emulsion (vehicle) for 24 weeks. Four fingernails of each patient were included; the 2 most severe brittle nails and the second most normal nail were treated with the same medication. The fourth nail, the most normal nail, remained untreated and was used to assess nail growth. The prespecified primary endpoint was change from baseline in Physician Global Assessment (PGA) score (0 to 5 scale) at each follow-up visit. Safety evaluations were conducted at each visit.
RESULTS: In the intent-to-treat population (n=12 for each treatment arm), the PGA score for treated nails improved from baseline (CsAE, 0.7 to 1.4; emulsion, 0.7 to 1.5; P<0.05 for each), with no significant between-group differences. Untreated nails did not improve in overall appearance (0.0 to 0.3 grade; P>0.05). Statistically and clinically significant improvement from baseline was reported for nail length/appearance in both CsAE and vehicle groups.
LIMITATIONS: Sample size was relatively small. The difference in PGA between treated and untreated nails was not analyzed. Baseline disease severity may have been too mild, limiting detection of efficacy.
CONCLUSIONS: Both CsAE and emulsion vehicle applied topically appeared to improve signs and symptoms of brittle nail syndrome and were well tolerated. These findings warrant corroboration in a larger population and inclusion of comparison with an inactive control and a higher concentration of CsAE, the former which may help in distinguishing the efficacy of vehicle emulsion from CsAE.
J Drugs Dermatol. 2014;13(10):1232-1239.
Hector Fernández-Llaca MD,a Pablo de la Cueva MD,b Jesús Luelmo MD,c Jose Carlos Armario-Hita MD,d
M Luz Samaniego,e and Carmen García-Calvo MDf [Representing the RECOR Study Group.],
BACKGROUND: Cardiovascular morbidity and mortality have been demonstrated to be greater in psoriasis patients than in the general population. Our study aimed to assess the 10-year cardiovascular risk in patients with moderate to severe psoriasis compared with those suffering from other dermatological diseases, using the calibrated Framingham risk score and the Systematic Coronary Risk Evaluation (SCORE) risk charts.
METHODS: A cross-sectional, multicentre study was made of 477 patients, of whom 238 had moderate to severe psoriasis (cases) and 239 were diagnosed with another dermatological disease (controls).
RESULTS: The proportion of patients with intermediate to high 10-year cardiovascular risk using the Framingham equation was significantly higher among psoriasis patients (38.5%; 80/208) than among the controls with other dermatological diseases (23.4%; 50/214, P<.05). No significant differences were observed between the 2 groups with respect to cardiovascular risk using the SCORE risk charts (P=.591). The case group included a greater proportion of obese and morbidly obese patients, as well as patients with higher triglyceride and low density lipoprotein cholesterol levels (P<.05); while high density lipoprotein cholesterol levels were significantly more favorable in patients in the control group (P<.05).
CONCLUSIONS: Cardiovascular risk was greater in patients with moderate to severe psoriasis than in patients with other dermatological conditions, suggesting that early detection and tailored management of risk factors is essential to reducing cardiovascular morbidity in these patients.
J Drugs Dermatol. 2014;13(10):1240-1247.
Yau-Li Huang MD,a,b Shyue-Luen Chang MD,a,b Mei-Ching Lee MD,a,b
Chih-Hsiang Chang,a,b Sindy Hu MD MS,a,b and Michael H Gold MDc
BACKGROUND: Occipital scars from donor strip harvesting during hair transplantation are an important cosmetic concern. Scalp laxity has an important role, due to the more frequent use of dense packing and megasession transplantation, which requires more grafts and creates a wider, longer donor scar.
OBJECTIVE: To determine if the use of a simple, objective measurement of occipital scalp laxity could reduce scar length by allowing for adjustment of donor strip harvesting during hair transplantation.
METHODS AND MATERIALS: This retrospective study included data from 39 patients who underwent hair transplantation with >2000 follicular units: 25 patients underwent measurement of occipital scalp laxity (measurement group); the other 14 did not (control group). We measured and calculated preoperative scalp parameters for hair transplantation, including follicular unit density at occipital scalp, length and width of the donor strip, and estimated total number of grafts. All patients underwent standard follicular-unit hair transplantation, at which time the actual total number of grafts was determined.
RESULTS: Mean occipital follicular unit density in the measurement group was 74.16 follicles per cm2, which did not significantly differ from the controls (73.29; t=0.410, d.f.=37, P>0.05). The mean length of the occipital surgical wound was significantly shorter in the measurement group than in the controls (19.16 vs 27.50 cm, respectively; t=10.412, d.f.=37, P<0.05). The difference between the estimated and actual total number of grafts was significant in the measurement group (2139.44 vs 2397.64, respectively; paired t=3.095, d.f.=48, P<0.05) but not in the control group (2277.71 vs 2296.71, respectively; paired t=0.175, d.f.=26, P>0.05). Accuracy in estimating the total number of grafts was poor for the measurement group, as the number of actual grafts significantly exceeded estimates.
CONCLUSION: Use of data from a simple, objective method to measure occipital scalp laxity simplified adjustment of strip harvesting, allowed for use of wider strips, and resulted in smaller donor wounds and scars from hair transplantation; however, accuracy in estimating the total number of grafts was reduced.
J Drugs Dermatol. 2014;13(10):1248-1252.
Anthony Chiaravalloti MDa and Michael Payette MD MBAb
IMPORTANCE: Hailey-Hailey disease, or familial benign chronic pemphigus, is a rare genodermatosis that can be challenging for both patients and dermatologists as the disease can significantly impact patients’ quality of life and is often difficult to control. In recalcitrant cases, multiple treatment modalities are often needed to obtain benefit. Unfortunately, most of the available evidence pertaining to treatment is scattered across case reports and retrospective analyses.
OBJECTIVE: To review successful treatments of Hailey-Hailey, synthesize the evidence, and provide recommendations for therapy.
Findings: The best evidence exists for treatment with topical steroids and topical antimicrobials. Refractory disease has shown the most benefit with addition of oral antibiotics, excisional procedures and botulinum toxin A. Other therapies are described but with much less supporting evidence.
CONCLUSIONS: Herein we review the literature to identify successful treatments for Hailey-Hailey disease. We have outlined the treatments with the most evidence. The difficult nature of treating this disease requires that clinicians approach each patient differently. The literature shows that no one regiment works for all patients.
J Drugs Dermatol. 2014;13(10):1254-1257.
Yan Li MD, Sisi Yu MS, Jing Xu MS, Ruina Zhang MS, and Junying Zhao BS
BACKGROUND: Current studies have demonstrated the efficacy and safety of laser intervention in the treatment of onychomycosis. The objective of this study was to compare the efficacy of long-pulsed Nd:YAG 1064 nm laser for treatment of toenails onychomycosis with fingernails onychomycosis.
METHODS: One hundred and twelve affected fingernails or toenails in 37 patients with onychomycosis were randomized into Group 1 (22 patients with 50 affected fingernails) and Group 2 (15 patients with 62 affected toenails). These patients were further classified into three subgroups (Grade II, III, and IV) according to Scoring Clinical Index of Onychomycosis. All the affected nails were treated with long-pulse Nd:YAG 1064 nm laser intervention, once weekly, for continuous weeks, and were followed up for 24 weeks.
RESULTS: The response rates at weeks 8, 16, and 24 were 0, 0 and 52%, respectively, for Group 1, and 10, 32 and 71% for Group 2. The inter-group difference in efficacy was statistically significant (P<0.05). Even in the same subgroup, the response rate of Group 2 was higher than that of Group 1.
CONCLUSIONS: The efficacy of long-pulsed Nd:YAG 1064 nm laser intervention against affected toenails is superior to that against fingernails. It is also effective for treatment of onychomycosis with different severity.
J Drugs Dermatol. 2014;13(10):1258-1263.
Amer N. Kalaaji, MDa and Warren Wallo, MSb
Xerosis is a common skin condition, occurring most often in the winter and in low relative humidity, which results in loss of moisture, cracking, and desquamation. Many emollient creams and lotions are available for use as preventive moisturizers. However, few controlled experiments have been published comparing the efficacy of active moisturizing products versus the vehicle used to deliver the products to the skin. Therefore, we conducted this randomized, double-blind, controlled clinical study to objectively compare a commercially available moisturizing product against its own vehicle. The active colloidal oatmeal moisturizer used in this study showed significant benefits versus its vehicle control in several dermatological parameters used to measure skin dryness.
J Drugs Dermatol. 2014;13(10):1265-1268.
Andrew S. Dorizas MD,a Amer H. Nassar MD,a and David J. Goldberg MDb,c
OBJECTIVE: We determine if the use of Multispectral Digital Skin Lesion Analysis for the evaluation of nevi in children and possible detection of malignancies.
EVIDENCE REVIEW: Evidence gathered from a pivotal study involving 1,383 patients with 1,831-pigmented lesions. The isolated use of the pediatric population within this study was used to determine the specificity and sensitivity of such a device with comparison to a dermatologists evaluation.
FINDINGS: For all lesions from the assessed pediatric population the biopsy ratio was equivalent for the Multispectral Digital Skin Lesion Analysis device as for the dermatologists when performing as independent reviewers. Furthermore analyzed data suggests that dermatologists who incorporate the Multispectral Digital Skin Lesion Analysis device perform better than they would independently or if they were to follow the device blindly without incorporating their own judgment.
CONCLUSION AND RELEVANCE: An approach that integrates automated imaging technology like the Multispectral Digital Skin Lesion Analysis device, along with another diagnostic aid, with the end result being cost-effective, easy to use by even non-experts and comforting for the pediatric patient is likely to compete to be the new gold standard in successful early diagnosis and management of melanoma.
J Drugs Dermatol. 2014;13(10):1269-1273.