A Single Arm No-treatment Self-controlled Trial Pilot Study Evaluating the Clinical Efficacy and Safety Profile of 20% Cassia Alata Cream Against Tinea Versicolor

Tinea (pityriasis) versicolor is a common superficial fungal infection. A variety of topical antifungals are used in its treatment. In Jamaica, many people use crushed leaves of the Cassia alata plant (Senna alata) as a traditional remedy. Rare investigators have described its activity against the causative fungus, Malassezia spp. Aim: We wish to confirm the efficacy of the extract, devise dosing regimen, document potential side effects Study Design/Methodology: A single-arm arm no-treatment self-controlled trial pilot study evaluating the clinical efficacy and safety profile of 20% Cassia alata cream against tinea versicolor. Therapeutic efficacy reported as clinical and microbiological resolution of tinea versicolor in treated area will be assessed and compared with non-treated areas. Side effects and ease of use will be evaluated for and reported. Assessment will occur at baseline, 1 week, 4 weeks, 8 weeks and 12 weeks. Demographics will be tabulated and categorical variables generated. Associations of the presence/absence of these variables within both groups will be evaluated for using chi-squared tests. Results will be analyzed using SPSS version 26. Location: Dermatology Division (Room 13 Dept of Pathology) at University Hospital of the West Indies. Data Storage: Unique study ID, locked room and password protected computer belonging to the principal investigator. Only approved study investigators will have access. Time frame: 24 months months Confidentiality Statement: This study requires approval by the Ethics Committee, will require an informed consent and will comply with ethical rules governing research using human subjects, patient confidentiality and non-coercion as detailed within the proposal.