A Study of the Clinical Efficacy and Safety of 100% Cassia Alata Extract Against Tinea Versicolor

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the effects of Cassia alata extract in treating tinea versicolor (ring worm skin condition) to placebo consisting of alcohol, green food colouring and glycerin in adult Jamaicans ages 18 to 89 years. The main questions the study aims to answer are:• Does the use of this extract heal the kills the ring worm fungus and clears up the rash faster compared to placebo • Does the use of this extract have significant side effects ie Is it safe compared to placebo. Participants will be asked to apply a small portion about 1 ml of the extract or placebo to the skin rash twice daily at least 8 hours and attend dermatology clinic every 4 weeks for 12 weeks.

Detailed Description
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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: Prospective single-blinded (participant) two-arm (parallel) randomized placebo controlled pilot study examining for efficacy of a 100% Cassia alata extract to a placebo solution. Therapeutic efficacy reported as clinical and microbiological resolution of tinea versicolor will be assessed. 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 23. Location: Dermatology Outpatient Clinic and/or Dermatology Ward Procedure Rooms 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: 12 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.

Official Title
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A Single-blinded, Parallel-arm, Randomized Placebo-controlled Pilot Study Evaluating the Clinical Efficacy and Safety Profile of 100% Cassia Alata Extract Against Tinea Versicolor

Conditions
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Tinea Versicolor

Intervention / Treatment
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* Drug: Cassia alata extract
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-89 of either sex Clinical features suggestive of tinea versicolor AND Microscopic confirmation using skin scraping stains with chlorazol black preparation AND or Wood's lamp fluorescence No treatment for versicolor in the preceding 4 weeks No contraindications to the application of C.alata extract in solution including No history of allergy to C. alata No history of preservative allergy No history of allergy to adhesives/tapes Exclusion Criteria: Age <18 or >89 years Pregnant females History of hypersensitivity to C. alata or preservative Treatment within 4 weeks prior to enrollment Lesions which do not meet the diagnostic criteria of tinea versicolor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>a solution consisting of alcohol base, green food colouring and glycerin | Drug: Placebo<br>* 1 ml placebo solution<br>|
| Active Comparator: Treatment<br>Cassia alata extract | Drug: Cassia alata extract<br>* 1 ml Cassia alata extract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion Clearance | Proportion of participants with no visible lesions on which treatment applied | 12 weeks | 
| Fungal load | Change in the fungal load on skin scrapping | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| painful skin reaction | Proportion of participants with painful lesion on which treatment applied | 12 weeks | 
| Blistering skin lesion | Proportion of participants with blistering of lesion on which treatment applied | 12 weeks | 
| Itching or Redness | Proportion of participants with icthing or redness of lesion on which treatment applied | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tinea Versicolor,, Cassia alata extract