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194 participants with mild to moderate atopic dermatitis were randomly assigned to receive vehicle cream or 0.1%, 0.3%, or 1.0% PAC‐14028 cream twice daily.

PAC‐14028, a transient receptor potential vanilloid subfamily member 1 (TRPV1) agonist, appears to be a safe and effective topical treatment for patients with mild to moderate atopic dermatitis, according to data published in the British Journal of Dermatology.  

Researchers in this double‐blind, multicenter, vehicle‐controlled, 8‐week, phase IIb trial randomly assigned 194 participants with mild to moderate atopic dermatitis into groups receiving vehicle cream or 0.1%, 0.3%, or 1.0% PAC‐14028 cream twice daily. The primary efficacy end point was success rate defined as percentage of participants with an Investigator’s Global Assessment (IGA) score of 1 or 0 at week 8. Secondary end points included Eczema Area and Severity Index (EASI) 75/90 and Scoring of Atopic Dermatitis (SCORAD).  

At week 8, IGA success was achieved by 14.58% of participants in the vehicle cream group compared with 42.55% in the 0.1% PAC-14028 group (P =.0025 vs vehicle), 38.30% in the 0.3% PAC‐14028 group (P =.0087 vs vehicle), and 57.45% in the 1.0% PAC‐14028 group (P <.001 vs vehicle). Statistically significant differences between treatment groups and vehicle cream were particularly observed for 2-grade IGA success rate improvements from baseline (4.2% for vehicle cream; 21.3% for 0.1% PAC‐14028, P =.0121; 27.7% for 0.3% PAC‐14028, P =.0017; and 38.3% for 1.0% PAC‐14028, P <.001). Trends towards improvement were seen in EASI 75/90, SCORAD index, pruritus visual analogue scale, and sleep disturbance score for all treatment groups, with significant improvements observed in sleep disturbance score from week 3 of treatment in the 1.0% PAC‐14028 cream group (P <.05 vs vehicle). There were no significant safety issues reported.

Study investigators concluded that PAC‐14028 cream is an effective, favorably tolerable treatment option for mild to moderate atopic dermatitis. They noted that “[b]ased on these results, a phase III programme is underway to assess the efficacy and safety of PAC‐14028 topical cream 1.0% in adolescent and adult patients with mild‐to‐moderate AD (NCT02965118).”

Disclosures: Study funding was provided by AmorePacific Corporation.

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Reference

Lee YW, Won CH, Jung K, et al. Efficacy and safety of PAC‐14028 cream – a novel, topical, nonsteroidal, selective TRPV1 antagonist in patients with mild‐to‐moderate atopic dermatitis: a phase IIb randomized trial [published online January 8, 2019]. Br J Dermatol. doi: 10.1111/bjd.17455

The investigators sought to determine how the natural environment or diet protects potentially at-risk populations from such allergic conditions as atopic dermatitis.

A detailed microbiome analysis conducted in a group of children from rural South African communities has revealed differences in the gut microbiota of toddlers with atopic dermatitis (AD) linked to their diet. Results were published in the Journal of Allergy and Clinical Immunology.

The investigators sought to determine how the natural environment or diet protects potentially at-risk populations from such allergic conditions as AD, thus helping to elucidate the causes of the current global increase in atopic diseases. They characterized the gut microbiota of South african black (Xhosa) children from the remote rural Mqanduli district of the Eastern Cape in association with AD. Patients with AD were recruited from the Dermatology Department of the Nelson Mandela Academic Hospital in Umtata, Eastern Cape, South Africa. Control, nonallergic, non-food-sensitized participants were recruited from areas surrounding 10 district community health clinics.

A total of 83 children were recruited for this study: 36 participants with AD and 47 control patients without AD. The fecal microbiota of these children were analyzed and compared with respect to the presence of AD, other clinical variables, and their diet.

AD was significantly associated with food sensitization (P =.0001), but not with allergic rhinitis (P =.14) or wheezing (P =.73). Moreover, children with AD had a significantly higher daily consumption of total sugar (P =.007) and saturated fat (P =.003) than control patients.

Notably, having been breastfed at all, as well as the duration of exclusive breastfeeding and total breastfeeding, was not associated with an individual’s AD status (P =.73, P =.67, and P =.72, respectively).

The relative abundance of Prevotella copri was significantly decreased in children with AD compared with those without the disorder (1.45±3.94 vs 0.38±0.53, respectively; P <.00001). Further, children with high sugar content in their diet had significantly lower P copri levels than those with lower median sugar intake (0.43±0.52 vs 1.04±3.32, respectively; P <.0001).

The investigators concluded that based on the decreased prevalence of P copri in the participants with AD, these bacteria may play a protective role against the development of this disorder. Additional studies are warranted to evaluate the underlying mechanism of this association relative to gut microbiota.

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Reference

Mahdavinia M, Rasmussen HE, Botha M, et al. Effects of diet on the childhood gut microbiome and its implications for atopic dermatitis [published online December 19, 2018]. J Allergy Clin Immunol. doi: 10.1016/j.jaci.2018.11.034

Differentiating between allergic and irritant reactions can have direct implications on managing care for patients with dermatitis.

Thermography is an effective, reliable method to distinguish between allergic contact dermatitis and irritant contact dermatitis, according to the results of a study conducted at the University Hospital Zurich, in Switzerland. Findings from the analysis were published in the journal Allergology International.

When diagnosing allergic vs irritant contact dermatitis, the key factor is the distinction between allergic and irritant reactions, which can have direct implications on patient management. With the knowledge that patch testing of contact allergens is a useful, traditional tool, the investigators sought to evaluate a new method for the noncontact infrared reading of patch tests. In addition, secondary study objectives included a possible link between the intensity of the patch test reaction and changes in temperature.

A total of 420 positive reactions from patients were included in the study. Positive reactions were assessed by an independent patch test reader and classified as an allergic (+ to +++) or an irritant reaction. Concurrently, a forward-looking infrared (FLIR) camera attachment for an iPhone was used to acquire infrared thermal images of the patch tests, with all images analyzed via use of the FLIR ONE app.

The results of the study showed that allergic patch test reactions were exemplified by increases in temperature of 0.72°C±0.67°C compared with the surrounding skin. In contrast, irritant reactions were associated with a temperature rise of only 0.17°C±0.31°C. The mean difference in temperature between the two groups was highly statistically significant at P <.0001 and thus was used to predict an individual’s type of contact dermatitis.

The investigators concluded that the study results suggest that infrared imaging has the potential of becoming an innovative, useful, promising tool for standardized examinator independent assessment of patch tests. Findings demonstrated that allergic patch test reactions are significantly warmer than irritant reactions.

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Reference

Anzengruber F, Alotaibi F, Kaufmann LS, et al. Thermography: high sensitivity and specificity diagnosing contact dermatitis in patch testing [published online December 28, 2018]. Allergol Int. doi: 10.1016/j.alit.2018.12.001

The primary outcomes were extent of repigmentation, color match, and pattern of repigmentation at 24 weeks.

In patients with vitiligo and a short duration of clinical stability (DS) of 3 to 6 months, use of a novel combination of noncultured epidermal cell suspension (NCES) and noncultured dermal cell suspension (NDCS) is associated with an excellent response compared with the use of NCES alone, according to results of a single-center, randomized clinical trial (ClinicalTrials.gov identifier: NCT03013049). This study was conducted in the Department of Dermatology, Venereology, and Leprology, Postgraduate Institute of Medical Education and Research, Chandigarh, India. Findings from the study were published in JAMA Dermatology.

In this pilot study, the investigators sought to evaluate the efficacy of transplantation of NCES plus NDCS vs NCES alone in patients with vitiligo and DS for 3 months to 6 months or DS for >12 months. Overall, 40 patients with focal, segmental, or generalized vitiligo of 3 to 6 months’ duration or >12 months’ duration were enrolled in the study. According to DS, 2 groups containing 20 patients each were recruited for the study (DS in group 1: 3-6 months; DS in group 2: >12 months). Each of these groups was then further randomly assigned to 2 subgroups, A and B.

Patients in subgroups 1A and 2A received NCES alone, whereas patients in subgroups 1B and 2B received NCES plus NDCS. The main study outcomes included the extent of repigmentation, color match, and pattern of repigmentation at 24 weeks. The mean participant age was 24.9±4.0 years; 60% of the patients were women.

In group 1 (DS for 3-6 months), >75% repigmentation at 24 weeks was reported among all 10 patients in subgroup 1B (NCES+NDCS) compared with 3 of 10 patients in subgroup 1A (NCES alone; 100% vs 30%, respectively; P =.003), which was statistically significant. In contrast, in group 2 (DS for >12 months), >75% repigmentation at 24 weeks was observed in 6 of 10 patients in subgroup 2A and in 7 of 10 patients in subgroup 2B (NCES; 60% vs 70%; P >.99), which was not statistically significant.

The investigators concluded that the use of combined NCES and NDCS is a novel technique that can be used successfully in patients with vitiligo who have a short duration of disease stability (ie, 3-6 months). Future studies with larger sample sizes and longer follow-up periods are warranted to monitor the long-term stability of achieved repigmentation and to further examine the implication of dermal mesenchymal stem cells in individuals with active vitiligo.

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Reference

Thakur V, Kumar S, Kumaran MS, Kaushik H, Srivastava N, Parsad D. Efficacy of Transplantation of combination of noncultured dermal and epidermal cell suspension vs epidermal cell suspension alone in vitiligo: a randomized clinical trial [published online January 2, 2019]. JAMA Dermatol. doi: 10.1001/jamadermatol.2018.4919

Further research is needed to analyze the mechanisms that are needed for an effective intervention program.

Improving health literacy for patients with psoriasis may lead to improved self-management skills, self-efficacy, and quality of life, according to a study published in the British Journal of Dermatology.

Researchers of this cross-sectional study evaluated the relationship between health literacy, psoriasis severity, medical comorbidities, psoriasis knowledge, quality of life in relation to dermatology, and self-efficacy in patients with moderate to severe psoriasis who participated in the Norwegian Climate Helio therapy program. Questionnaire packets were mailed to 1275 adults who participated in the therapy program between 2011 and 2017.

Of the 825 patients (mean age, 53.3 years) who completed the questionnaires, 47.4% were women, 14.3% were using biological medicines, 35.5% had a history of depression, 66.8% reported joint pain. In regards to the first 5 scales in the health literacy questionnaire, “actively managing my health” (mean score=2.78, SD=0.51) had the highest score and “appraisal of health information” (mean score=2.54, SD=0.54) had the lowest score. In regards to the last 4 scales in the health literacy questionnaire, “understanding health information well enough to know what to do” (mean score=3.56, SD=0.62) had the highest score and “navigating the healthcare system” (mean score=3.10, SD=0.71) had the lowest score.

After bivariate associations were calculated for demographic data, men had a lower score on “actively managing my health” (β=0.1; P =.01), while education level predicted “ability to find good health information” (β=-0.13; P =.01) and “ability to understand health information well enough to know what to do” (β=0.12; P =.01). After bivariate associations were calculated for clinical variables, fewer comorbidities were related to higher scores in “having social support for health” (-β=0.12; P =.01) and “ability to navigate the healthcare system” (-β=0.10; P =.001). Self-efficacy was significantly associated with all health literacy scales, the Dermatology Life Quality Index significantly predicted higher health literacy scores in all scales other than “actively managing health” and “critical appraisal”, and psoriasis knowledge significantly predicated higher health literacy scores in all scales other than “actively managing health” and “social support for health.”

Limitations of this study include the questionnaires only being paper-based and in Norwegian, which could limit response rates, and that all answers are self-reported without clinical verification. Further research is needed to analyze the mechanisms that are needed for an effective intervention program.

The researchers concluded that “improving [health literacy] may be a useful strategy for reducing disparities in self-management skills, self-efficacy and [quality of life]” in patients with moderate to severe psoriasis.

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Reference

Larsen MH, Strumse YAS, Borge CR, Osborne R, Andersen MH, Wahl AK. Health literacy – a new piece of the puzzle in psoriasis care? [published online December 31, 2018]. Br J Dermatol. doi: 10.1111/bjd.17595

The primary outcome of the study included identifying somatic mutations linked with cherry angiomas.

A study recently published in JAMA Dermatology has identified 5 genetic factors contributing to cherry angiomas, supporting the role of genetics in its pathogenesis. Hot spot variants of R183 and Q209 suggest a common genetic family between cherry angiomas and other vascular anomalies.

This single-center case series utilized cherry angioma tissue samples from 10 participants whose ages ranged from 26 to 79 years; 60% were women. Samples were paraffin-embedded, formalin-fixed, and sequenced across a collection of 323 cancer-related genes. A large portion of mutations (215 out of 234) were excluded due to poor mapping quality, germline, or evidence of intronic mutations. The primary outcome of the study included identifying somatic mutations linked with cherry angiomas. A functional impact score was assigned to each mutation, with the majority of scores ranging from -2 to 4 and higher scores correlating with higher likelihood of either a driver or functional mutation.

There were 5 samples in which 19 somatic missense mutations with high functional impact scores (≥3.5) were identified, occurring in GNA11 (Q209H) and GNAQ (Q209R, R183G, and Q209H). Vascular entities associated with these genetic hot spots include uveal melanoma, blue nevi, hepatic small-vessel neoplasms, Sturge-Weber syndrome, port-wine stains, and anastomosing and congenital hemangiomas. GNAQ/GNA11-wild-type and -mutant samples did not differ in terms of the number of structural variants, though structural variants were higher in female participants (P =.002).

Limitations to this study included a lack of separation of specific angioma cell variants from others as well as a small sample size. Future studies should include additional samples as well as the prospective biopsy of several lesions on one participant.

The study researchers concluded that there is “a possible role for GNAQ– and GNA11-mediated signaling in [cherry angioma] pathogenesis, a finding consistent with the genetic underpinnings of vascular anomalies. We observed both R183 and Q209 hot spot variants among [cherry angiomas], suggesting that [cherry angiomas] are possibly on a shared genetic spectrum with vascular entities, such as congenital and anastomosing hemangiomas, capillary malformations, port-wine birthmarks, and Sturge-Weber syndrome, and melanocytic growths, such as blue nevi, melanoma associated with blue nevus, and uveal melanoma.”

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Reference

Klebanov N, Lin WM, Artomov M, et al. Use of targeted next-generation sequencing to identify activating hot spot mutations in cherry angiomas [published online January 2, 2019]. JAMA Dermatol. doi: 10.1001/jamadermatol.2018.4231

Of the 3 interventions, only patients who received the polyherbal combination tablets showed a significant decrease in facial redness of 40% compared with baseline.

A 4-week regimen of 4000 mg turmeric polyherbal combination tablets was found to be superior to turmeric alone and placebo in improving facial redness, according to a study recently published in the Journal of Integrative Medicine.

In this prospective, single-center, grader-blinded, double-blind randomized pilot study, generally healthy patients aged 25 to 60 years (N=28) completed the trial at the Department of Dermatology, University of California, Davis from August 2016 and July 2017. Participants were each given a bottle of 240 tablets and instructed to take 4 tablets orally twice daily. The tablets contained one of 3 possible interventions: placebo (n=9), turmeric (n=10), and turmeric polyherbal supplements (n=9). Facial redness was assessed by clinical grading and image-based analysis at baseline and at 4 weeks.

Of the 3 interventions, only patients who received the polyherbal combination tablets showed a significant decrease in facial redness of 40% compared with baseline (P =.03). There were no statistically significant changes in facial redness in either the placebo or turmeric tablet groups. A positive correlation was found between facial redness intensity and distribution that trended toward decrease only in the polyherbal combination group, although this trend was not significant (P =.1).

Limitations of this study included short study duration, although facial redness can be detected at an earlier stage than clinical changes. Participants were advised to avoid all turmeric-containing foods in their diets during the study course, but intake of other herbs would have been difficult to monitor.

These findings suggest that the antioxidant and anti-inflammatory properties of the turmeric-containing polyherbal tablet play a role in the factors related to facial erythema. Further studies are warranted to quantify the effects of turmeric polyherbal formulations.

Disclosure: One author declared affiliations with the pharmaceutical industry. Please refer to reference for a complete list of authors’ disclosures.

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Reference

Vaughn AR, Pourang A, Clark AK, Burney W, Sivamani RK. Dietary supplementation with turmeric polyherbal formulation decreases facial redness: a randomized double-blind controlled pilot study [published online November 22, 2018]. J Integr Med. doi: 10.1016/j.joim.2018.11.004

Cosentyx is a human interleukin-17A antagonist

According to pooled data from four Phase 3 studies, treatment with secukinumab (Cosentyx; Novartis) was associated with improvement in mobility, self-care, and usual activities (e.g., work, study, housework, family or leisure activities) when compared with placebo in patients with moderate-to-severe plaque psoriasis.

In the ERASURE, FIXTURE, FEATURE, and JUNCTURE trials, psoriasis patients who reported problems in these quality of life measures (through the EQ-5D-3L questionnaire) were randomized to receive secukinumab 300mg or placebo and were assessed at weeks 4, 8, and 12. Results showed that at week 4, the percentage of patients reporting no problems in mobility (60.7%), self-care (71.4%), or change in usual activities (63.8%) was higher in the secukinumab group than in the placebo arm (38.5%, 40.9%, and 31.1%, respectively); similar trends were observed at week 8 and 12.

“Moderate-to-severe plaque psoriasis can impact every aspect of a person’s life,” stated Steven R. Feldman, MD, PhD, Wake Forest School of Medicine. “These findings suggest that helping patients feel better through improved quality of life and ability to function should be a goal as important as skin clearance in psoriasis management.”

Cosentyx, a human interleukin-17A antagonist, is FDA-approved for the treatment of: moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy; adults with active psoriatic arthritis; and adults with active ankylosing spondylitis.

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For more information visit Novartis.com.