RecruitingPhase 1NCT05730244

A Study of the Clinical Efficacy and Safety of 20% Cassia Alata Extract Against Tinea Versicolor

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


Sponsor

The University of The West Indies

Enrollment

20 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to establish the efficacy of Cassia alata extract as a cream form in treating tinea versicolor (liver spots/shifting clouds). The main questions the study aims to answer are:• Does the use of this extract help resolve tinea versicolor better than no treatment? Does the use of this cream have significant side effects i.e, is it safe? Participants will be asked to treat a designated area while leaving additional areas untreated. 1-2 finger tip units of cream will be applied to the treatment site twice daily at least 8 hours apart. Participants will attend the trial clinic every 4 weeks for 12 weeks.


Eligibility

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria6

  • 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 cream including
  • No history of allergy to C. alata
  • No history of preservative allergy

Exclusion Criteria5

  • 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

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Interventions

DRUG20% Cassia alata cream

Thin layer of cassia alata cream to cover treatment area. 1 finger tip unit will cover roughly 4 x 4 inch area. Number of FTU determined by investigators depending on rough size of area to be treated


Locations(1)

University of the West Indies, Mona

Kingston, Other, Jamaica

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NCT05730244


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