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

CREC-MN.29, 2021/2022

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.

2023-02-15

2023-12-31

2024-06-30

Not yet recruiting

Early phase I

60

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-02-21