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TOPIC SKIN Face and Body Cream Clinical Study

ABSTRACT:

- 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.

- 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%, or '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.

Atopic dermatitis (AD) is a common chronic inflammatory skin disease with a lifetime prevalence of 10-20% in children and 1-3% in adults.1 AD usually starts in early infancy and is typified by pruritus, erythematous papulovesicular lesions, xerosis (dry skin), and lichenification of the skin.2 In severe cases, intense pruritus (itching) and scratching may lead to secondary infection.1 AD is usually associated with other atopic diseases as asthma and other allergic reactions.

TOPIC SKIN Face & Body Cream is a barrier-based non-steroidal homeopathic formula emulsion based on botanicals, which is especially formulated to manage the symptoms of various dermatoses such as atopic dermatitis, contact dermatitis, nummular dermatitis, hand dermatitis, radiation dermatitis, and burns. This 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.

BSA raw data collected per each visit in weeks duration. 

BSA improvement per each visit in weeks duration. 

Visual improvement after 28 days (A) before treatment on day 0 (B) following treatment on day 28.

 

 

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