Journal of Clinical and Aesthetic Dermatology

Skinfix 2018

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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S7 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY January 2018 • Volume 11 • Number 1 • Supplement T H E I M P O R TA N C E O F S K I N B A R R I E R M A I N T E N A N C E A N D R E PA I R by dermatologist investigators and study subjects. Study 3: Moderate-to-severe hand xerosis/ history of chronic hand dermatitis. This was a single-center, open-label, uncontrolled, one-week study that included adult subjects (N=35) with moderate-to-severe hand xerosis, characterized by dryness and cracking, with a history of chronic hand dermatitis including from occupational causes. 35 The objective of this study was to evaluate whether a moisturizer cream containing sweet almond oil 7% and colloidal oatmeal 2% (HR cream; Skinfix Hand Repair Cream) could alleviate the associated signs and symptoms. Methodology. Subjects applied HR cream at least three times per day to the hands, with avoidance of hand washing, touching, wiping, or toweling of hands for at least 15 minutes after application. At baseline, prior to application, signs and symptoms of disease severity and corneometry readings were captured on the dorsal hands. The first dose of HR cream was applied under supervision, with a second corneometry reading performed 15 minutes after application. All participants completed daily study diaries. At Week 1 (end of study), Global Improvement Assessment (GIA) scores were recorded, individual signs and symptoms of disease were assessed, corneometry testing was repeated, and safety and tolerability were evaluated. Enrolled subjects. Thirty-six subjects with moderate or severe xerosis and a history of chronic hand dermatitis were enrolled. 35 One subject discontinued early due to reasons unrelated to study medication. The mean subject age was 42.9 years, with the majority female (57.1%) and Caucasian (74.3%). Conventional inclusion and exclusion criteria methods were incorporated. Assessments. The primary efficacy parameter was the GIA score comparison to baseline (6-point scale: 0=moderate or greater worsening, 1=slight worsening, 2=no change, 3=slight improvement, 4=moderate improvement, 5=marked improvement). Individual signs of scaling, cracking, erythema, dryness, and pruritus were assessed using a 10-point rating scale (0=clear, 1–3=mild, 4–6=moderate, and 6–9=severe). Corneometry measurements were completed as described above. Safety outcomes included documentation of any AEs and adverse changes related to skin tolerability, including application site reactions. Study outcomes. All subjects experienced global improvement at Week 1. The average GIA score across both hands at Week 1 was 4.40, with a score of 4 defined as moderate improvement and a score of 5 defined as marked improvement compared to baseline (P<0.001). Mean GIA scores were 4.40 for both the left hand (P<0.001) and right hand (P<0.001); the minimum recorded GIA score was 3 (slight improvement) and the maximum score was 5 (marked improvement). Individual signs of scaling, cracking, erythema, and dryness, and the symptom of pruritus all showed statistically significant improvements after one week compared to baseline (p<0.001). Average severity score percent reductions in dryness, scaling, skin cracking, erythema, and pruritus were 76.1, 75.7, 92.0, 61.0, and 88.3 percent, respectively. Marked improvements in corneometry readings were noted after application of HR cream at both the 15 minute post-baseline and Week 1 measurements. Significant corneometry improvements were observed in 91.4 percent of subjects at Week 1, with a mean increase of 110.9 percent versus baseline (both hands average, p<0.001). Satisfaction with HR cream after one week of use was reported based on individual assessment questions in 80 to 90 percent of subjects. For example 80 percent reported that HR cream worked quicker and more effectively than other previously used products, and 80 percent noted that HR cream healed their hand eruption. HR cream was well tolerated with no worsening of stinging, tightness, or tingling of the skin; 2.9 percent noted worsening of burning sensation. Author commentary on clinical relevance. This study demonstrates that HR cream is beneficial in reducing signs and symptoms associated with chronic xerosis of the hands that is moderate to severe in intensity, including patients with a history of chronic hand dermatitis. This is likely to offer the additional benefit of reducing the common reflex to apply a TCS, even when clinical manifestations are predominantly xerotic in nature with minimal visible inflammation. The efficacy results suggest that the combination of sweet almond oil and colloidal oatmeal collectively provide barrier protectant, anti-inflammatory, and anti-pruritic effects. HR cream is adaptable for long term use. REFERENCES 1. Del Rosso JQ, Levin J. The clinical relevance of maintaining the functional integrity of the stratum corneum in both healthy and disease-affected skin. J Clin Aesthet Dermatol. 2011;4(9):22–42. 2. Elias PM. The epidermal permeability barrier: from Saran Wrap to biosensor. In: Elias PM, Feingold KR, eds. Skin Barrier. New York: Taylor & Francis; 2006:25–32. 3. Harding CR. The stratum corneum: structure and function in health and disease. Dermatol Ther. 2004;17:6–15. 4. Braff M, Di Nardo A, Gallo RL. Keratinocytes store the antimicrobial peptide cathelicidin in lamellar bodies. J Invest Dermatol. 2005;124:94–100. 5. Cook M, Danby SG, Vasilopoulos Y, et al. Epidermal barrier dysfunction in atopic dermatitis. J Invest Dermatol. 2009;129:1892–1908. 6. Dirschka T, Tronnier H, Fölster-Holst R. Epithelial barrier function and atopic diathesis in rosacea and perioral dermatitis. Br J Dermatol. 2004;150:1136–1141. 7. 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Ceramide-dominant barrier repair lipids alleviate childhood atopic dermatitis: changes in barrier function provide a sensitive indicator of disease activity. J Am Acad Dermatol. 2002;47:198–208. 13. Thiboutot D, Del Rosso JQ. Acne vulgaris and the epidermal barrier: is acne vulgaris associated with inherent epidermal abnormalities that cause impairment of barrier functions? do any topical acne therapies alter the structural and/or functional integrity of the epidermal barrier? J Clin Aesthet Dermatol. 2013;6(2):18–24. 14. Del Rosso JQ. The use of moisturizers as an integral component of topical therapy for rosacea: clinical results based on the assessment of skin characteristics study. Cutis.

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