Efficacy of Avène Hydrotherapy on Chronic Pruritus in Patients with Plaque Psoriasis.

INTRODUCTION: Pruritus is a prevalent symptom, described as one of the most bothersome of psoriasis. Specific itch management remains a challenge, for which hydrotherapy could be used as adjunct care to medical treatment. Therefore, we assessed the immediate and longer-term benefit of 3 weeks of Avène thermal spring water hydrotherapy on chronic pruritus in patients in addition to their usual psoriasis and/or pruritus management. METHODS: Twenty-six patients suffering from chronic pruritus due to psoriasis were evaluated before and after 3 weeks of hydrotherapy with a 3 and 6 month follow-up. A control group (18 patients) did not undergo hydrotherapy and continued to follow their usual skin management. Pruritus was assessed according to the numeric rating scale (NRS, pruritus intensity), the visual dynamic pruritus score (vDPS, change in pruritus intensity), and the 5-D itch scale (pruritus characteristics). Psoriasis severity was measured using the psoriasis area and severity index (PASI) score. The "itchy quality of life" (ItchQoL) scale was used to assess quality-of-life (QoL) impact related to itch. Pruritus and psoriasis gene and protein biomarkers were measured in lesional and nonlesional skin. RESULTS: Pruritus measurements (NRS, vDPS, and 5-D itch scale) indicated an immediate and long-lasting positive effect of hydrotherapy compared with control patients. The psoriasis area and severity index (PASI) was decreased by 40.0% by hydrotherapy, which was sustained over 6 months. The ItchQoL also improved directly after hydrotherapy, which was still much improved even 6 months later. Analysis of gene and/or protein biomarkers revealed a significant decrease of inflammation biomarkers (IL-8, IL-1α, IL-1RA, and RANTES), of psoriasis biomarkers (PI3, S100A7, and IL-17), and of pruritus biomarkers (IL-31, TRPV1, and CGRP1). CONCLUSIONS: These findings demonstrated an immediate and long-lasting improvement of pruritus in patients with psoriasis who underwent Avène thermal spring water hydrotherapy, indicating that this would be a good complementary therapy in the management of this disease. TRIAL REGISTRATION: NCT03023254.

The usefulness of a dermocosmetic containing Myrtus communis extract and azelaic acid for maintenance phase of adult female acne: Results from a randomized exploratory investigator-blinded comparative study.

BACKGROUND: Acne is a very common condition. Currently, there are relatively few studies available to help guidance-based decisions for its long-term management, especially studies with cosmetic care products. We have developed a skin care product dedicated to adult female acne. OBJECTIVES: Evaluate the efficacy and tolerance of the test product containing Myrtus communis extract and azelaic acid compared with a light moisturizing cream (LCM) in adult females in the acne maintenance phase. METHODS: A clinical study was conducted as a Brazilian, multicentre, randomized, investigator-blinded trial in adult females with clear or almost clear facial acne after anti-acne treatment. The test group (26 subjects) applied the test product and the comparative product group (27 subjects) applied LCM. Both groups applied the products twice daily on the whole face. Subjects were evaluated every 4 weeks over 16 weeks. Efficacy was evaluated according to acne relapse; Investigator's Global Assessment (IGA); acne lesions counting; AcneQoL questionnaire; Subject Global change Assessment (SGA) of acne severity; and the number of Post-Inflammatory Hyperpigmentation (PIH) and Post-Inflammatory Erythema (PIE) lesions. Tolerance was assessed according to a 5-point scale. RESULTS: Over 16 weeks, the number of acne relapse was more than double in the comparator compared to the test product group (eight subjects vs. three subjects respectively). There was no statistical difference in the evolution of the mean IGA from baseline between the two groups; however, 85% of subjects were assessed as clear or almost clear in the test product group and 67% in the comparative group. CONCLUSIONS: This study demonstrated the effectiveness topical application of the test product compared to LCM on acne severity in the maintenance phase of adult female acne. Efficacy results after 16 weeks suggested a trend to limit acne relapses and a benefit of the test product in maintaining long-term remission.

Tolerability and Efficacy of a Medical Device Repairing Emollient Cream in Children and Adults with Mild to Moderate Atopic Dermatitis.

INTRODUCTION: Regular emollient application is recommended for managing atopic dermatitis (AD). Although many emollients are available, only AD-tested medical device repairing emollient creams (MDRECs) can be recommended for treating and preventing AD skin lesions. Here, we evaluated the tolerability and benefit of a new MDREC in an open-label study in infants, young children, and adults with mild to moderate AD. METHODS: Subjects (or their parents or guardians) were instructed to apply the MDREC to AD lesions or areas of dry skin twice daily for 3 weeks. Investigators assessed tolerability and AD severity at days 1, 8, and 22. Subjects assessed AD severity weekly, recorded any adverse events, and reported their satisfaction with the MDREC at day 22. RESULTS: Sixty-one subjects (19 infants, 22 children, and 20 adults) were included and 59 completed the study. At inclusion, 49% of the infants and young children and 15% of the adults were experiencing flares of AD. At day 22, the local tolerability of the MDREC was judged by the investigators as excellent in all the children and in 18 of the 20 adult subjects (90%). All adverse events were mild and transient. Investigator- and subject-assessed AD severity progressively decreased at each assessment for each age subgroup. CONCLUSION: This study shows that the MDREC was well tolerated when applied to AD skin lesions in infants, young children, and adults and suggests this product can be used daily to control the signs and symptoms of AD. FUNDING: Laboratoires Dermatologiques Ducray, Pierre Fabre Dermo-Cosmétique.

Correction to: Efficacy and Tolerability of a Medical Device Repairing Emollient Cream Associated with a Topical Corticosteroid in Adults with Atopic Dermatitis: An Open-label, Intra-individual Randomized Controlled Study.

The original article can be found online.

Tolerability and efficacy of a medical device repairing emollient cream in adults with chronic hand dermatitis.

BACKGROUND: Emollients are recommended for managing chronic hand dermatitis (CHD). Medical device repairing emollient creams (MDRECs) are suitable for treating CHD-associated skin lesions, unlike most cosmetic emollient products that can only be used on healthy skin. OBJECTIVES: The aim of this study was to examine the tolerability and benefit of a MDREC, Dexyane MeD® , in adults with CHD. METHODS: In an open-label study, adults aged 18-65 years with mild-to-moderate CHD were instructed to apply the MDREC on both hands twice daily for 3 weeks. Investigators assessed tolerability and CHD severity on days 1, 8, and 22. Subjects assessed CHD severity weekly and completed the Dermatology Life Quality Index on days 1, 8, and 22. Differences from baseline were compared by Wilcoxon matched-pairs signed-rank test or paired t test. Satisfaction with the MDREC was assessed by subjects. RESULTS: Forty subjects were included and completed the study. Tolerability was good to excellent for all subjects. Subjects and investigators reported decreased severity of CHD at days 8 and 22 compared with Day 1 (P < 0.001), and subjects reported decreased pain and pruritus (P < 0.001). Quality of life improved, and most subjects were satisfied with the MDREC's characteristics and application. CONCLUSIONS: The MDREC was well tolerated and may help manage mild-to-moderate CHD.

Efficacy and Tolerability of a Medical Device Repairing Emollient Cream Associated with a Topical Corticosteroid in Adults with Atopic Dermatitis: An Open-label, Intra-individual Randomized Controlled Study.

INTRODUCTION: Medical device repairing emollient creams (MDRECs) are designed to repair and protect the skin barrier. In this study, we examined the added clinical benefit and tolerability of a MDREC when used in association with a moderately potent topical corticosteroid (TCS) for adults with atopic dermatitis (AD). METHODS: This was an intra-individual randomized controlled trial in adults with moderate to severe AD (EudraCT no. 2014-002,194-10). Symmetrical lesions on each arm of the subjects were randomized to treatment for 10 days with twice-daily TCS (desonide) cream alone or with combined TCS + MDREC. Subjects were then included in a following 2-week maintenance phase if the AD on at least one test area had sufficiently improved so that the treatment was no longer needed. During the maintenance phase, treatment with the TCS cream was stopped, but twice-daily application of the MDREC was continued on the same test area previously assigned to receive it. The primary outcome measure was the change in local Scoring Atopic Dermatitis (SCORAD) index between day 1 and 3 based on investigators' assessment. Secondary measures of lesion severity included changes in the local patient-oriented SCORAD index, pruritus intensity according to subjects' assessments, and global assessments by subjects and investigators. RESULTS: The study included 54 subjects. The change in investigator-observed local SCORAD index between day 1 and 3 was - 14.4% with TCS alone and - 24.5% for TCS + MDREC (p = 0.0005). Between baseline and the end of the treatment phase, all secondary measures of lesion severity decreased more with the combined TCS + MDREC treatment than with the TCS cream alone. The MDREC also reduced the relapse of AD lesions during the maintenance phase. Tolerability was very good, and the product was well accepted by subjects. CONCLUSION: These results support using the MDREC in association with TCS during AD flares and as a maintenance therapy after treatment with TCS has stopped. FUNDING: Laboratoires Dermatologiques Ducray, Pierre Fabre.

Effects of a New Emollient-Based Treatment on Skin Microflora Balance and Barrier Function in Children with Mild Atopic Dermatitis.

BACKGROUND/OBJECTIVES: The use of emollients is widely recommended for the management of atopic dermatitis (AD), especially between flares. An imbalance of skin microflora is suspected of playing a key role in exacerbations of AD. Our aim was to evaluate the effect of a new emollient balm on clinical parameters (SCORing Atopic Dermatitis [SCORAD], xerosis, pruritus), skin barrier function (transepidermal water loss and loricrin, filaggrin, corneodesmosin, and involucrin expression], skin microflora biodiversity, and Staphylococcus aureus and Staphylococcus epidermidis balance in children with mild AD. METHODS: Fifty-four children (1-4 yrs old) were enrolled in this randomized, controlled study. Subjects applied a hygiene product and the emollient balm (emollient group, n = 28) or the hygiene product only (control group, n = 26) twice a day for 28 days. RESULTS: We found improvement in favor of the emollient group in SCORAD (p < 0.001), pruritus (p = 0.06), and xerosis (p = 0.06) after 28 days of application. Moreover, transepidermal water loss decreased in the emollient group by 34% (p = 0.06) and involucrin expression by 37% (p = 0.001) at day 28 from baseline in association with improvement in barrier function, whereas other barrier-specific proteins did not vary. S. aureus increased significantly in the control group only (6.5 times, p = 0.01), whereas S. epidermidis remained stable in both groups. The Shannon index (H' = 2.3) did not vary with treatment in either group. CONCLUSION: Twice-daily application of a new emollient balm in children with mild AD protected the skin from S. aureus proliferation and preserved microflora biodiversity.

An innovative oat-based sterile emollient cream in the maintenance therapy of childhood atopic dermatitis.

Although emollients are recommended in the management of atopic dermatitis (AD), regimens for emollient maintenance therapy are awaiting validation. We conducted an international, multicenter, open-label trial to assess the effects of a 3-month maintenance treatment regimen with a sterile, preservative-free emollient cream containing oat plantlets in children (ages 6 mos-6 yrs) with moderate AD. After a 14-day run-in stabilization phase using a topical corticosteroid (TCS) treatment of medium potency, 108 children with a SCORing Atopic Dermatitis (SCORAD) index of 20 or less were included in the study. Emollient was applied twice daily for 3 months. Rescue TCS treatment was used only in cases of flare-ups. The SCORAD index, Patient-Oriented SCORAD (PO-SCORAD) index, number of flares, TCS use, and tolerance were assessed at months 1, 2, and 3 (M1, M2, M3). AD severity improved, with a highly significant decrease in the SCORAD and PO-SCORAD indexes at M2 and M3 (p < 0.001). Changes from baseline to M3 were 48.6 ± 73.6% for SCORAD and 29.6 ± 125.3% for PO-SCORAD. The number of flares and TCS use significantly decreased by M3 (both p < 0.001). Very good tolerance was recorded in 100% of children at M2 and M3. Notwithstanding the limitations inherent in open-label trials, twice daily application of the oat-based sterile emollient cream led to a significant improvement of clinical symptoms, evidenced by parallel changes in the SCORAD and PO-SCORAD indexes and fewer flare-ups. Clinical benefit and less TCS use were maintained at M3. Tolerance was very good.

Clinical and biochemical assessment of maintenance treatment in chronic recurrent seborrheic dermatitis: randomized controlled study.

INTRODUCTION: Few studies have investigated the long-term effects of a maintenance regimen in the prevention of relapses in scalp seborrheic dermatitis (SD), in particular following biomarker changes. MATERIALS AND METHODS: A new shampoo containing beta-glycyrrhetinic acid (18ßGA) in addition to cyclopiroxolamine (CPO) and zinc pyrithione (ZP) was tested in 67 subjects suffering from SD with moderate to severe erythema and itching in a biphasic study. After a first common intensive treatment phase (investigational product thrice a week × 2 weeks), subjects randomly received the investigational product once a week × 8 weeks (maintenance) or a neutral shampoo (discontinuation) in a comparative, parallel group maintenance phase. Efficacy was assessed clinically (overall clinical dandruff score, erythema, overall efficacy, self-evaluation), biochemically and microbiologically by quantitative polymerase chain reaction (qPCR), high performance liquid chromatography (HPLC) or enzyme-linked immunoabsorbent assay (ELISA) analysis of scale samples (Malassezia species (restricta and globosa), cohesion proteins (plakoglobins), inflammation (Interleukin (IL)-8, IL-1RA/IL-1α) and pruritus (histamine, cathepsin S) markers). RESULTS: During the intensive treatment phase, SD improved significantly (p < 0.0001) with a decrease in clinical signs as well as Malassezia species, cohesion proteins, inflammation and pruritus markers. During the maintenance phase, the improvement persisted in the 'maintenance' group only, with a significant intergroup difference. A consistently positive relationship was found between dandruff, itching, erythema and Malassezia populations, histamine levels and IL-1RA/IL-1α ratio. CONCLUSION: The effectiveness of this maintenance regimen was objectively demonstrated at the clinical, biochemical and microbiological level. Correlations between clinical signs and biomarkers could provide clues to explain the resolution of SD and confirm the interest of biomarkers for SD treatment assessment.