Randomized Placebo-controlled Study of the Clinical Efficacy and Safety of 100% Cassia Alata Extract Against Tinea Versicolor

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of The West Indies

Criteria

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 ( "spaghetti and meat-ball" appearance of fungal elements) +/- Wood's lamp fluorescence (microscopy is more sensitive and hence is the primary diagnostic requirement but where observed, fluorescence is an additional parameter which may be monitored for clearance) 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

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Exclusion Criteria:

• Age <18 or >89 years Pregnant females History of hypersensitivity to C. alata or preservative Treatment within 4 weeks prior to enrollment (a 4 week washout period will be offered to those interested in enrollment) Lesions which do not meet the diagnostic criteria of tinea versicolor