Published Clinical Studies

The Importance of Skincare for Neonates and Infants: An Algorithm

Lawrence A. Schachner MD FAAD FAAPa, Anneke Andriessen PhDb, Latanya Benjamin MD FAAP FAADc, Alanna F. Bree MDd, Peter A. Lechman MD MBA FAAPe, Ayleen A. Pinera-Llano MDf, Leon Kircik MD FAADg, Adelaide Hebert MD FAADh

The skin of neonates and infants undergoes a maturation process from birth and is susceptible to barrier disruption. The current algorithm follows a US-based consensus paper on skincare approaches using gentle cleansers and moisturizers in neonatal and healthy infant skin. When applied from birth onwards, gentle cleansers and moisturizers containing barrier lipids help maintain the protective skin barrier.

A Cohort Study on a Ceramide-Containing Cleanser and Moisturizer Used for Atopic Dermatitis

C. W. Lynde, A. Andriessen

Atopic dermatitis (AD) is a chronically relapsing inflammatory skin disorder. In this cohort study, we evaluated the effectiveness of a twice-daily regimen of a ceramide-containing cleanser and moisturizer in men, women, and children with AD (N=151). The treatment period was 6 weeks. Participants were evaluated at baseline (day 0) and at the end of treatment (day 42) using clinical photographs, the SCORAD (SCORing of Atopic Dermatitis) index, and quality of life (QOL) assessment. Participants were randomly selected and were allocated to 1 of 2 groups: group 1 with participants 12 years and older (n=118) and group 2 with participants younger than 12 years (n=33). At day 42, SCORAD scores for group 1 showed significant improvement (t115=18.33, P=.0001). Skin condition in group 2 was evaluated by the participants’ guardians. At day 42, SCORAD scores for group 2 showed significant improvement (t27=5.38, P=.0001). Similar effects were observed for itching, with scores that improved from very itchy to itching only when the skin was wet (t27=5.38, P=.0001). No adverse events were reported during the 6-week evaluation period. The study results indicate that the ceramide-containing cleanser and moisturizer regimen substantially improved skin condition and clinical outcomes related to AD severity as well as QOL aspects.

The Effect of Ceramide-Containing Skin Care Products on Eczema Resolution Duration

Z. D. Draelos

Eczema is a common dermatologic condition that affects children as well as adults and is related to a defective skin barrier, which is most commonly caused by damage to the intercellular lipids from improper selection of skin cleansers and moisturizers. A new concept in skin care is the incorporation of ceramides into therapeutic cleansers and moisturizers. Ceramides are important components of the intercellular lipids that are necessary to link the protein-rich corneocytes into a waterproof barrier that is capable of protecting the underlying skin tissues and regulating body homeostasis. This study evaluated the effect of both a multilamellar vesicular emulsion (MVE) ceramide-containing liquid cleanser and moisturizing cream plus fluocinonide cream 0.05% compared with a bar cleanser plus fluocinonide cream 0.05% in the treatment of mild to moderate eczema. The addition of an MVE ceramidecontaining liquid cleanser and moisturizing cream to a high-potency corticosteroid enhanced the treatment outcome of mild to moderate eczema compared with the use of a bar cleanser and high-potency corticosteroid in reducing disease duration, time to disease clearance, and symptoms. Thus, skin care product selection can have an important clinical effect on the clearance of mild to moderate eczema.

An Investigation of the Skin Barrier Restoring Effects of a Cream and Lotion Containing Ceramides in a Multi-vesicular Emulsion in People with Dry, Eczema-Prone, Skin: The RESTORE Study Phase 1

The purpose of this study was the provide evidence of the benefits of a cream and equivalent lotion containing skin lipids in a multi-vesicular emulsion for the management of dry skin.Compared to three reference emollient creams the test cream and test lotion were the only products capable of sustaining clinically meaningful improvements in skin moisturization for 24 hours.

Efficacy of Ceramide-Containing Formulations on UV-Induced Skin Surface Barrier Alterations

The impact of ultraviolet radiation on skin cancer and photaging has been extensively studied. However, the direct impact of UVR on skin barrier integrity under clinical settings remains poorly explored. Due to their benefits in reducing inflammation and promoting skin barrier repair, ceramide-containing formulations can provide added photoprotection benefits. In this study, the efficacy of a ceramide-containing sunscreen and moisturizer were evaluated in preventing UV-induced skin surface barrier changes.

Evidence of Barrier Deficiency in Rosacea and the Importance of Integrating OTC Skincare Products into Treatment Regimens

Addressing barrier dysfunction by use of moisturizer and cleanser formulations that restore skin hydration, normalize skin pH, restore the microbiome, and skin lipids can assist in improving rosacea signs and symptoms. In addition to occlusives and humectants, barrier restoring ingredients such as ceramides, hyaluronic acid, and niacinamide were considered beneficial.

Moisturizers and Ceramide-containing Moisturizers May Offer Concomitant Therapy with Benefits

C. Lynde, A. Andriessen, B. Barankin, G. De Gannes, W. Gulliver, R. Haber, C. Mccuaig, P. Rajan, S. Skotnicki, R. Thomas, J. Toole, R. Vender

An expert panel of 11 Canadian dermatologists, including an international clinical scientist, used the following modified Delphi process: 1) A systematic literature review for acne treatment, dry skin, irritation, depletion of ceramides in acne, and benefits of moisturizers and ceramide-containing moisturizers was conducted; 2) panel members gave their opinion on the resulting statements, taking into account their treatment practices; 3) a panel meeting was held during the 2011 Canadian Dermatology Update to determine final statements; 4) the panel reviewed the final document. Results: The panel reached the following consensus (11/11): 1) A very important reason for nonadherence to acne treatment is dry skin and irritation; 2) skin barrier dysfunction may contribute to acne; 3) dry skin and irritation commonly results from topical acne treatment; 4) dry skin and irritation commonly results from systemic retinoid therapy; 5) moisturizers can improve dryness and irritation resulting from acne treatment; 6) ceramide-containing moisturizers may enhance adherence and complement existing acne therapies; 7) adjunctive therapy with moisturizers should be considered in acne-treated patients. Conclusion: The panel proposes that adjunctive therapy with moisturizers, particularly ceramide-containing moisturizers, should be considered in acne-treated patients.

Multivesicular Emulsion Ceramide-containing Moisturizers: An Evaluation of Their Role in the Management of Common Skin Disorders

J. Zeichner, Q. Del Rosso

Proper stratum corneum function plays a pivotal role in maintenance of skin health, and improper function leads to skin disease. The stratum corneum is comprised of corneocytes surrounded by intercelluar lipids including ceramides, free fatty acids, and cholesterol. Ceramide predominant moisturizers have become a mainstay of treatment of skin disease. New technologies for delivery of ceramides include multivesicular emulsions, which deposit ceramides in a timerelease manner for a continuous rather than burst effect. Here, the authors review the available data on the use of multivesicular emulsion ceramide moisturizers in various skin diseases.

An Investigation of the Skin Barrier Restoring Effects of a Cream Containing Ceramides in a Multi Vesicular Emulsion in People with Dry, Eczema-Prone, Skin: The Restore Study

Danby SG, Andrew PV, Kay L, Pinnock A, Chittock J, Brown K, Cork MJ

• Disruption of the skin barrier leads to skin dryness and is an
underlying cause of eczema (dermatitis)1
• Management of dry skin conditions involves the regular and
liberal use of moisturisers (emollients)2
• Moisturisers exhibit very different properties, yet there is
limited evidence that one moisturiser is better than another3
• In 2018 the UK National Health Service (NHS) prescribed 8
million moisturising creams at a cost of £50 million (GBP), of
which 52% were simple emollient creams (see table)4
• The CeraVe cream and lotion contain humectants and skin
lipids with slow-release multi-vesicular emulsion (MVE)
technology to deliver longer-lasting skin hydration

Cohort Using a Ceramides Containing Cleanser and Cream with Salicylic Acid for Dry, Flaking, and Scaling Skin Conditions

Ronald B.Vender MD FRCPC, Anneke Andriessen PhD, Benjamin Barankin MD FRCPC, Anatoli Freiman MD FRCPC, Dimitrios Kyritsis MD FRCPC, Loukia-Maria Mistos MD FRCPC, Jennifer Salsberg MD FRCPC, Laetitia Amar MD

The skin of subjects with dry, flaking, and/or scaling conditions is characterized by decreased water and skin lipids con-tent among other findings. It is well understood that daily use of gentle cleansers and moisturizers may help to restore and maintain an optimal skin barrier function. A cohort study of patients with dry skin was developed to evaluate efficacy of daily use of a ceramide containing cleanser and cream that also has salicylic acid.

Ceramide- and Keratolytic-containing Body Cleanser and Cream Application in Patients with Psoriasis: Outcomes from a Consumer Usage Study

James Q. Del Rosso, DO

Ceramides are epidermal lipids that play an essential role in stratum corneum function, including maintaining physiologic permeability barrier properties. The role of ceramides in the maintenance and repair of epidermal barrier function is believed to be valuable in the treatment of psoriasis. Normalization of corneocyte desquamation and the incorporation of agents that promote desquamation to reduce hyperkeratosis are also regarded as key factors in psoriasis management.

An Investigation of the Skin Barrier Restoring Effects of a Cream containing Ceramides in a Multi Vesicular Emulsion in People with Dry, Eczema-prone, Skin: The Restore Study Phase 2. Annual Meeting of The American Academy of Dermatology 2020

Danby SG, Andrew PV, Kay LI, Pinnock A, Chittock J, Brown K, Cork MJ

The skin of atopic dermatitis (AD) patients is characterised by abnormal stratum corneum (SC) lipid levels. Consequently, the lamellar matrices are disrupted and skin barrier function is diminished, increasing skin sensitivity to irritants and allergens. The objective was to investigate whether a cream containing skin lipids (ceramides, triglycerides and cholesterol) in a multi-vesicular emulsion can reinforce the skin barrier. An observer-blind intrasubject-controlled study in 34 people (aged 20-89), prone to AD, with dry skin was conducted. Each participant underwent 4 weeks treatment with the test cream on one forearm and lower leg and a reference emollient cream on the other (randomized). Skin properties were determined before and after treatment. Lipid structure was assessed using FTIR spectroscopy.

Evaluation of the Efficacy of an Exfoliating Cleanser and Urea-Containing Cream on Keratosis Pilaris using Clinical and 3D Image-Based Analysis. Annual Meeting of The American Academy of Dermatology 2020

Petra Staubach, Nada Baalbaki, Iqra Iqbal, Margarita Yatskayer, Gene Colon

Individuals with keratosis pilaris (KP) can be affected emotionally, often trying to conceal, the evident keratin plugs and follicular erythema associated with the condition. Hyperkeratotic skin can benefit from topical formulations that hydrate to soften keratin and promote desquamation. Herein, we describe the efficacy evaluations for a daily ceramide-containing regimen including an exfoliating cleanser and cream with urea in women with KP on their upper arms or outer thighs. A 3D image-based analysis was employed to assess the texture of skin with KP for the first time. This study included 45 women ages 18-50 years with moderate tactile and visual roughness additional mild to moderate follicular erythema on the upper arms or outer thighs diagnosed as KP by a dermatologist. Clinical efficacy was evaluated by expert dermatologist grading for skin texture, follicular erythema and dryness additional self-assessment questionnaires at baseline, week 2, week 4 and week 8. Images were captured using a 2D Nomad Cam® and 3D imaging system Primos Lite®. Objective and subjective tolerance assessments were also performed at each study visit.

Evaluation of a Ceramide-Containing Lotion on Skin Hydration and Cellular Morphology Assessed by Reflectance Confocal Microscopy (RCM). Annual Meeting of The American Academy of Dermatology 2020

Nathalie De Carvalho, MD, Beatriz Santanna, Izabella Martorelli, Nada Baalbaki, Gene Colon

Ceramides are important components of intercellular lipids, necessary to link corneocytes into a waterproof barrier and enhance skin hydration. Skin hydration has impact on cell morphology at the surface and deeper layers of epidermis. The objective was to Evaluate the morphology of dry skin before and after treatment with a ceramide-containing moisturizer using in vivo Reflectance Confocal Microscopy (RCM). Thirty female patients from 18 to 45 years old, presenting dry skin (corneometry value ≤ 40 a.u.), were instructed to apply a ceramide-containing lotion twice daily to one forearm whereas the other was kept untreated for comparison. Subjects submitted to corneometer and RCM evaluations at baseline, day 7 and day 28. RCM features analysed were: corneal and epidermal thickness, irregularity of stratum corneum, size and morphology of epidermal folds, and morphology of keratinocytes in granular layer.

Anti-Pruritic Efficacy of Itch Relief Lotion and Cream in Patients With Atopic History: Comparison With Hydrocortisone Cream

Matthew J. Zirwas and Sylvia Barkovic

To evaluate the speed of onset and duration of relief of two ceramide-containing formulations with 1% pramoxine hydroxide (CeraVe® Itch Relief Lotion and Cream,Valeant Pharmaceuticals North America LLC, Irvine, CA) in patients with atopic history, including those with active flare and the comparative efficacy of CeraVe Itch Relief Cream to hydrocortisone 1% cream and night-time itch relief with continued use.

The Effect of a Ceramide-Containing Product on Stratum Corneum Lipid Levels in Dry Legs

Zoe D. Draelos MD, Nada H. Baalbaki PhD, Shelby Cook MS, Susana Raab BA MBA, Gene Colon Esq

Roughly equimolar concentrations of ceramides, cholesterol, and free fatty acids arranged in lamellar sheets form the intercellular lipid barrier in the stratum corneum (SC). Intercellular lipid deficiencies, specifically ceramides, and barrier disruption are associated with many dermatologic conditions, including dry skin. This study explored the relationship between the improvement in the signs of dry skin and the amounts of ceramides in the SC by combining clinical observations with a biochemical analysis to quantify the level of SC intercellular lipids. The efficacy of a multiamellar vesicular emulsion (MVE), ceramide-containing moisturizing cream was evaluated in a randomized, investigator-blinded, split-leg study on female subjects with dry, itchy skin. The cream increased skin hydration and demonstrated an immediate and sustained reduction in the visible signs of dry skin and subject perceived sensory discomfort. Additionally, ceramide, cholesterol and free fatty acid levels in the SC significantly increased after 4 weeks of moisturizer application. Thus, the clinical effect of the ceramide-containing moisturizing cream on dry, itchy skin was accompanied by an increase in SC intercellular lipid levels.

A Consensus About the Importance of Ceramide Containing Skincare for Normal and Sensitive Skin Conditions in Neonates and Infants

Lawrence A. Schachner, Anneke Andriessen, Latanya Benjamin, Alanna F. Bree, Peter A. Lechman, Ayleen A. Pinera-Llano, Leon H. Kircik

Neonates and infants are susceptible to skin barrier disruption as their skin anatomically and functionally is still developing. The process of skin acidification plays a vital role in barrier maturation and the activation of enzymes involved in the extracellular processing of stratum corneum lipids. The current consensus paper explores challenges, and current treatment approaches in neonatal and infant normal and sensitive skin and the role of ceramides containing moisturizers.

Dermatology in Contemporary Times: Building Awareness of Social Media’s Association With Adolescent Skin Disease and Mental Health

In a panel discussion, two experts provided insights into the psychosocial and social media impact of inflammatory skin conditions in adolescent patients. Results reported an association between poor sleep, social impairment, and mental health disorders, including body dysmorphic disorder (BDD) and depression in adolescents with acne or AD.