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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S6 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 inflammation as compared to HC 1% reducing TEWL primarily via the anti-inflammatory activity of the TCS (hydrocortisone). Safety outcomes. No adverse events (AEs) to either study medications were observed over the study duration. Statistically significant reductions in all cutaneous tolerability parameters were noted as compared to baseline (p<0.05) with no significant differences observed between study groups (p>0.05). QoL outcomes. Overall, the DLQI responses exhibited no significant differences in response at both follow-up time points (p>0.05). Author commentary on clinical relevance. This study demonstrated that application of Eczema Balm effectively and safely reduces signs and symptoms of mild and moderate AD/ED with results comparable to a low potency TCS (hydrocortisone). EB may be incorporated to assist in flare reduction of AD/ED and as a component of maintenance therapy between flares in patients with atopic skin and in those with phenotypically xerotic skin who are prone to eczematous dermatitis. Study 2: Keratosis pilaris. Keratosis pilaris (KP) is a common chronic, refractory skin disorder seen in children, adolescents, and adults. KP presents as small focal keratotic papules with varying degrees of perifollicular erythema, and is often associated with atopic skin; sites of predilection are the face, buttocks, posterior-lateral arms, and anterior thighs. 34 An OTC cream, formulated using multiple natural ingredients for treatment of KP (KP cream; Skinfix Renewing Cream), was evaluated in adult subjects with mild or moderate KP symmetrically affecting the arms or thighs. 23 The major ingredients of the KP cream are lime pearl extract (source of alpha- hydroxy acids), willow bark extract (source of salicylic acid), bisabolol, shea butter, and natural emollient oils. Objective. The objective of the study was to evaluate the efficacy of KP cream in adult subjects with KP involving the arms or thighs. 23 Methodology. The study was a single- center, randomized, investigator-blinded, split-body (subject as own control), two-week trial. KP cream was randomly assigned for twice daily application to one side (arm or thigh) affected with KP with the alternate KP-affected side remaining untreated. Study assessments were completed at baseline and Week 2. Subjects were instructed to apply a dime sized amount of KP cream to one assigned treatment site twice daily (morning and evening) for two weeks. The alternate symmetric site remained untreated over the duration of the study. Enrolled subjects. This study enrolled adults (age range 18–60 years; mean age 34.7 years) of both sexes (90% female) with clinically evident mild or moderate KP with symmetric involvement of arms or thighs (N=30). Subjects with severe erythema in the treatment area at baseline were excluded. Thirty-one subjects were enrolled with one subject withdrawing for reasons unrelated to study treatment. Assessments. At baseline and end of study (Week 2), the symmetric study sites were independently evaluated by two board certified dermatologist investigators. Visual evaluations were conducted for overall lesions (goose-bumpy skin), elevation of lesions from surface, extent of scaling, erythema, and skin texture (roughness) at each designated site utilizing a 4-point scale. At Week 2, a questionnaire was completed by all study subjects. Study outcomes. Clinical grading of study parameters showed that KP cream produced statistically significant improvements from baseline in overall lesions (p<0.001), scaliness (p=0.027), and skin roughness (p=0.006); no significant improvements were noted in elevation of lesions from the surface or in erythema. The untreated side experienced a significant decrease in overall lesions from baseline (p=0.011) but no improvements were observed in other parameters (Figure 2). KP cream produced significantly greater improvements from baseline compared to no treatment in overall lesions (p=0.004), scaliness (p=0.003), and skin roughness (p=0.012), with no significant differences observed in elevation of lesions or in erythema between sides (Figure 2). No safety concerns or AEs were reported during the study. The majority of subjects (60-80%) reported statistically significant favorable outcomes, with KP cream decreasing skin roughness/bumpiness (p<0.001 – p=0.010) and soothing pruritic skin (p<0.001). Author commentary on clinical relevance. KP is often persistent, subject to periods of increased spiny focal hyperkeratosis, and is notoriously refractory to many different topical treatments. This study supports effective and safe use of an OTC topical cream specifically formulated for use in KP. The OTC study cream decreased the tactile roughness/ bumpiness on the arms and thighs within two weeks based on independent evaluations FIGURE 2: Mean percent change from baseline clinical grading of keratosis pilaris: KP cream-treated side vs. untreated side

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