Deganit Barak-Shinar1,2, Lawrence J Green1,2. 1. Dr. Barak-Shinar is Vice President of Clinical, Regulation and Quality Assurance at Kamedis Ltd. in Tel-Aviv, Israel. 2. Dr. Green is Associate Clinical Professor of Dermatology at The George Washington University School of Medicine in Washington, DC.
Abstract
Objective: The aim of this study was to evaluate the safety and efficacy of an herbal and zinc pyrithione shampoo and a scalp lotion (Kamedis Derma-Scalp Dandruff Therapy, Kamedis Ltd., Tel Aviv, Israel) for the treatment of scalp seborrheic dermatitis and dandruff. Design: This was an interventional, open-label, safety and efficacy study. Setting: This open-label study was conducted at Consumer Product Testing Company Inc. in Fairfield, New Jersey. At the baseline visit (Day 0), an examination of the scalp was conducted by a board-certified dermatologist. The entire scalp was evaluated for evidence of seborrheic dermatitis using the Adherent Scalp Flaking Score with a 10-point scale. Only subjects with evidence of moderate-to-greater seborrheic dermatitis or moderate-to-greater dandruff were deemed qualified for inclusion in the study. Participants: Fifty subjects were recruited and included in the study. Measurements: Study subjects were evaluated by the same dermatologist for erythema and flaking at Days 0, 14, 28, and 42 using a five-point scale for each parameter. At each time point, a total severity score was calculated based on the findings of the evaluations. Following the scalp evaluation, each subject had a standardized digital photograph taken of his or her scalp. Each subject was also asked to answer a satisfaction questionnaire regarding the product treatment enhancement and characteristics. Results: A reduction in both parameters evaluated was seen at all time points. Statistical significance was achieved at each time point when compared with the baseline visit. In addition, the subjects expressed a high degree of satisfaction with the treatment. No adverse events were reported during this study. Conclusion: The study showed that the herbal zinc pyrithione shampoo and scalp lotion provided improvement in the main symptoms of seborrheic dermatitis.
Objective: The aim of this study was to evaluate the safety and efficacy of an herbal and zinc pyrithione shampoo and a scalp lotion (Kamedis Derma-Scalp Dandruff Therapy, Kamedis Ltd., Tel Aviv, Israel) for the treatment of scalp seborrheic dermatitis and dandruff. Design: This was an interventional, open-label, safety and efficacy study. Setting: This open-label study was conducted at Consumer Product Testing Company Inc. in Fairfield, New Jersey. At the baseline visit (Day 0), an examination of the scalp was conducted by a board-certified dermatologist. The entire scalp was evaluated for evidence of seborrheic dermatitis using the Adherent Scalp Flaking Score with a 10-point scale. Only subjects with evidence of moderate-to-greater seborrheic dermatitis or moderate-to-greater dandruff were deemed qualified for inclusion in the study. Participants: Fifty subjects were recruited and included in the study. Measurements: Study subjects were evaluated by the same dermatologist for erythema and flaking at Days 0, 14, 28, and 42 using a five-point scale for each parameter. At each time point, a total severity score was calculated based on the findings of the evaluations. Following the scalp evaluation, each subject had a standardized digital photograph taken of his or her scalp. Each subject was also asked to answer a satisfaction questionnaire regarding the product treatment enhancement and characteristics. Results: A reduction in both parameters evaluated was seen at all time points. Statistical significance was achieved at each time point when compared with the baseline visit. In addition, the subjects expressed a high degree of satisfaction with the treatment. No adverse events were reported during this study. Conclusion: The study showed that the herbal zinc pyrithione shampoo and scalp lotion provided improvement in the main symptoms of seborrheic dermatitis.
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