Kamedis™, a provider of advanced botanical solutions for chronic skin disorders, today announced the first U.S. clinical study designed to determine the efficacy of traditional Chinese botanicals in commercial dermatologic treatments. The double-blind, randomized, controlled study of Kamedis Calm Eczema Therapy Cream is evaluating the specific role of the product's patented combination of six Chinese botanical extracts in the mitigation of eczema symptoms.
Kamedis Calm Eczema Therapy Cream utilizes an exclusive formulation of Chinese Rhubarb, Great Burnet, Tree of Heaven, Baikal Skullcap, Cnidium Fruit and Licorice extracts in conjunction with conventional active and inactive ingredients. The barrier-based non-steroidal emulsion acts by adhering to the injured tissue, eliminating exogenous and contaminated factors related to dermatitis, protecting the skin from further irritation, and maintaining a moist skin environment. These effects facilitate natural healing of impaired skin barrier functions. Previous studies have demonstrated a 50% reduction of eczema flare-ups in two weeks.
The new clinical trial involves 108 children and adults with mild to moderate atopic dermatitis in six different geographies across the U.S. Subjects are randomized into three groups using Kamedis Eczema Therapy Cream, the Kamedis product without the Chinese botanical formulation, and a competitive OTC brand, respectively.
The protocol calls for measuring improvement on the Investigator's Global Assessment (IGA) scale at day 28; trends in the change of Scoring Atopic Dermatitis (SCORAD) and Eczema Area Severity Index (EASI) at days 0, 7, 14 and 28; changes in the Dermatology Life Quality Index (DLQUI) or Children's Dermatology Life Quality Index (CDLQI) at day 28; and various other secondary efficacy and safety outcomes.
The IGA, SCORAD, EASI and other symptom assessments will be performed by participating physicians. The quality of life questionnaires will be completed by the subjects.
The study also includes a patient satisfaction questionnaire at the end of the trial to examine issues such as the impact of the treatment on the family and comparison with past treatments.
Results are expected in late 2018.
About Kamedis
Kamedis develops effective, dermatologist-tested, botanical skincare products for a variety of chronic skin conditions including eczema, acne, dandruff, psoriasis, dry skin and itchy/irritated skin. Launched in Israel in 2003 and now sold worldwide, the company's products are based on extensive scientific research and development that included testing hundreds of traditional Chinese medicine botanicals and their combinations. The botanicals are produced in an ISO 13485 and ISO 9001-certified manufacturing facility ensuring quality and production consistency of botanical extracts. The unique extraction technique is developed to maximize formulation potency. All final products have been validated by dermatologists, are backed by dozens of clinical trials, and have received strong endorsement from consumers.
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