Efficacy of Topical Botanical Treatment of Children With Mild to Moderate Atopic Dermatitis

Objective: The study was conducted to determine the efficacy of the botanical combination incorporated in Kamedis Eczema Therapy Cream (the test product) for children with mild to moderate atopic dermatitis. Design: The study was designed as an interventional, multi-center, double-blind, randomized, controlled study. Setting: Children subjects were a sub-population of the 108 combined population of adults and children evenly randomly divided into three treatment groups: test product, vehicle, and comparator. The vehicle used was the identical test product without the botanical combination while the comparator was a leading OTC brand in the US market. All three groups used the same Kamedis body wash followed by one of the three randomized treatment creams for the affected areas. Participants: Thirty-nine (39) children subjects with uncomplicated, stable, mild to moderate atopic dermatitis were recruited and qualified for the study, 24 female and 15 male, ages varying between 3 and 18. Measurements: Investigators assessed the severity of each subject using the Investigator Global Assessment (IGA), affected Body Surface Area (BSA) extent evaluated parameters at each of the visit days 0, 7, 14, and 28. Subjective symptoms of pruritus and insomnia were evaluated by the patient or their legal guardian. The SCORAD and EASI indexes were calculated based on the collected parameters. Results: The test product demonstrated an improvement in all evaluated and calculated clinical parameters over the vehicle at the end of the treatment duration, proving the validation that the test product is much more effective and beneficial than the vehicle. The test product reached 40% of 'clear' IGA subjects out of the enrolled subjects and 60% out of the 'clear' and 'almost clear' IGA subjects comparing to 8% and 38%, respectively, with the vehicle, presenting a clear advantage over the vehicle. The BSA improvement comparison analysis of the test product over the vehicle yielded P value of less than 0.05, which is statistically significant. The SCORAD and EASI indexes also showed an advantage of the test product versus the vehicle at week 4. Conclusion: The study results validate that the botanical combination is the key factor for the efficacy and improvement of the AD symptoms within this population of children. J Drugs Dermatol. 2019;18(10):1038-1045.

Validation of Botanical Treatment Efficiency for Adults and Children Suffering from Mild to Moderate Atopic Dermatitis

Objective: The study was conducted to determine the efficiency of the botanicals combination incorporated in the Kamedis Eczema Therapy Cream (the tested product) for adults and children suffering from mild to moderate Atopic Dermatitis. Design: The study designed as an interventional, multi-center, double-blind, randomized, controlled study. Setting: Subjects were evenly randomly divided into three treatment groups: tested product, vehicle, and comparator. The vehicle used was the identical tested product without the botanical combination while the comparator was a leading OTC brand in the US market. All three above groups used a similar Kamedis wash for the body and face following by one of the three randomized treatment creams for the affected areas on the face and body. Participants: One hundred and eight (108) subjects with uncomplicated, stable, mild to moderate atopic dermatitis recruited and qualified for the study; 71 females and 37 males, age 3 to 73. Measurements: The investigator assessed the severity of each subject using the Investigator Global Assessment (IGA) and affected body surface area (BSA) at each of the visit days 0, 7, 14, and 28. Results: The tested product demonstrated an improvement in IGA and BSA over the vehicle at every visit across treatment time, proving the validation that the botanical product is much more effective and beneficial than the same product without the botanicals. The tested product as well as the comparator reached exactly the same percentage, 34%, of 'clear' IGA subjects of the enrolled subjects, presenting advantage over the vehicle. The BSA improvement comparison analysis of the tested product over the vehicle yielded statistically significant P value of 0.0369. Conclusion: The study results approve and validate that the botanical combination is the key factor for the efficacy and improvement of the AD symptoms within this study population. J Drugs Dermatol. 2019;18(6):557-561.