Efficacy of Pseudo-Ceramide-Containing Steroid Lamellar Cream in Patients with Mild to Moderate Atopic Dermatitis: A Randomized, Double-Blind Study.

INTRODUCTION: Atopic dermatitis (AD) is a chronic inflammatory skin disorder involving decreased barrier function of the stratum corneum. This decrease, caused by a reduction in ceramide, the primary component of intercellular lipids in the stratum corneum, leads to a disturbance in the lamellar structure. METHODS: We developed a formulation (test cream) containing a steroid and synthetic pseudo-ceramide (SLE: N-(3-hexadecyloxy-2-hydroxypropyl)-N-2-hydroxyethyl hexadecanamide) that forms a lamellar structure on the skin after its application and drying. The formulation or control cream (a formulation containing a steroid but not pseudo-ceramide that does not form a lamellar structure) was applied twice daily for 2 weeks to the lesional area of 34 participants with mild to moderate AD symptoms. RESULTS: The test cream showed a periodic structure with an interface space of approximately 8.2 nm in transmission electron microscopy and small- and wide-angle X-ray scattering, similar to the lamellar structure in the human stratum corneum. In the double-blind test, the anti-inflammatory effects of the test cream (n = 17) were comparable to those of the control cream (n = 17). In the test cream group, a significant increase in the stratum corneum moisture content (p < 0.01) and significant decrease in transepidermal water loss (p < 0.05) were observed at weeks 1 and 2 after application compared with those before application. No such change was observed in the control group. CONCLUSION: The results indicate that, even with a relatively short application period of 2 weeks, the test cream not only suppressed inflammation of the lesional area, but also improved the inherent barrier function of the stratum corneum, suggesting its potential as a treatment option for patients with AD.

Effects of a moisturizer containing pseudo-ceramide and a eucalyptus extract on sweating function in adult atopic dermatitis: a double-blind, randomized, controlled left-right comparison clinical trial.

BACKGROUND: Many patients with atopic dermatitis (AD) have a decreased ability to sweat. Several factors can cause decreased perspiration, such as weak tight junctions of sweat ducts, reduced acetylcholine receptor function, and inhibition of perspiration by histamines. Parakeratosis of AD skin also decreases sweating by occluding sweat pores. Increased ceramide levels in the stratum corneum reduce parakeratosis by improving stratum corneum functions. Furthermore, ceramides and/or ceramide derivatives may affect claudin-3 and acetylcholine receptors. OBJECTIVE: In this study, we investigated the efficacy of a moisturizer containing pseudo-ceramide and a eucalyptus extract to increase ceramide levels in the epidermis to improve the sweating ability of patients with AD. METHODS: Nineteen patients with AD applied moisturizers with or without pseudo-ceramide and a eucalyptus extract on the cubital fossa of either arm twice a day for 4 weeks. Skin conditions and sweating ability, measured as the response to acetylcholine stimulation, were evaluated prior to the start of the study (Week 0) and at the end of Weeks 2 and 4. RESULTS: Both moisturizers improved the visually evaluated skin symptoms and skin hydration. However, only the moisturizer containing pseudo-ceramide and the eucalyptus extract significantly improved cutaneous barrier function and significantly increased the ceramide level in the stratum corneum. That moisturizer also increased the sweating volume and shortened the latency time for sweating, an indicator of sweating ability, but the other moisturizer did not. CONCLUSION: Based on these results, the moisturizer containing pseudo-ceramide and a eucalyptus extract helps recover the sweat function of AD patients.

Efficacy of Heparinoid Cream Containing Pseudo-Ceramide for Remission of Atopic Dermatitis.

PURPOSE: Atopic dermatitis (AD) is characterized by chronic inflammation, which frequently recurs, is exacerbated, and enters remission. A maintenance remission period is important for AD patients. We developed a formulation for use during AD remission, containing heparinoid and pseudo-ceramide that forms a lamellar structure. We evaluated the allergen permeability and examined the formulation's efficacy in maintaining remission in patients with AD. MATERIALS AND METHODS: Seventeen AD patients applied a cream containing 0.3% heparinoid and pseudo-ceramide (test cream group, n = 10), or a general cream containing 0.3% heparinoid (control cream group, n = 7) to their arm for four weeks after inducing remission with the application of a steroid cream for two weeks. RESULTS: The lamellar structure of the test cream was confirmed with small- and wide-angle x-ray scattering analysis and observation by transmission electron microscopy. The test cream inhibited the penetration of V8 protease significantly compared to the control cream in vitro. According to AD severity score by dermatologists, the effects remission maintenance of the test cream group were comparable to those of the control cream group. However, the test cream group had a significantly increased skin hydration value compared to the control cream group. A significant decrease in transepidermal water loss, an indicator of skin barrier function, was shown in the test cream group compared to the control cream group. CONCLUSION: The cream with lamellar structures containing heparinoid and pseudo-ceramides may inhibit allergen penetration. Moreover, skin properties improved during the remission period; thus, the formulation we developed was suitable for use during the AD remission period.

Efficacy of a moisturizer containing a pseudo-ceramide and a eucalyptus extract for Japanese patients with mild atopic dermatitis in the summer.

BACKGROUND: Skin moisturizing is advocated to take care of the skin of patients with atopic dermatitis (AD). However, many patients stop using moisturizers in the summer because of excessive sweating and high humidity. OBJECTIVES: To examine the efficacy of a moisturizing gel containing a pseudo-ceramide and a eucalyptus extract, which enhances epidermal ceramide synthesis of patients with mild AD in the summer. METHODS: We performed a single-blinded 4-week clinical trial of body care on 44 Japanese subjects who had mild AD. They had not applied any moisturizer on their body in the summer. Twenty-seven subjects used the moisturizing gel containing a pseudo-ceramide and a eucalyptus extract twice a day and the 17 other subjects did not use any moisturizer. Prior to and at the end of weeks 2 and 4, the skin conditions of each subject were evaluated. RESULTS: During the test period, the atmospheric temperature increased and skin dryness and scaling significantly improved with or without application of the moisturizing gel. However, the improvement in dryness of the treated group was significantly higher than that of the nontreated group. Erythema and itchiness were significantly improved only in the treated group. The skin hydration on the forearm increased significantly only in the treated group. Accompanying those improvements, the quality of life of the subjects, evaluated by Skindex-16® , was significantly improved. CONCLUSION: The usage of a moisturizer containing a pseudo-ceramide and a eucalyptus extract is effective for care of the skin of AD subjects even in the summer.

Efficacy of the combined use of a facial cleanser and moisturizers for the care of mild acne patients with sensitive skin.

Acne is a common skin disease that involves the seborrheic area of the face and results from the obstruction of hair follicles followed by inflammation. Careful face washing helps to improve and prevent acne; however, intensive washing has a risk of inducing skin barrier impairment and dry skin, especially in sensitive skin. We hypothesized that skin care combining mild skin cleansing and intensive moisturizing ("combination skin care") may be effective in the care of acne in subjects with dry skin and/or sensitive skin. We developed a combination skin care with a weakly acidic foaming facial skin cleanser based on a mild detergent, an aqueous lotion with eucalyptus extract and a moisturizing gel containing pseudo-ceramide and eucalyptus extract. To optimize an ideal facial skin care system for mild acne on sensitive skin, we performed a 4-week clinical trial with 29 post-adolescent Japanese women with mild acne with dry and sensitive skin. The acne significantly decreased after this trial accompanied by the improvement of dry skin, a significantly increased endogenous ceramide level in the stratum corneum and an elongated alkyl chain length of the non-hydroxy acyl sphingosine type ceramide. No adverse events due to the test samples were observed. Based on diagnosis by a dermatologist, 97% of the subjects found the combination skin care to be "useful" or "slightly useful". Based on these findings, the combined use of a facial skin cleanser and moisturizers is safe and effective for the care of acne in post-adolescent Japanese women with sensitive skin.