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

November 14, 2025 updated by: The University of The West Indies

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Jamaica
    • Other
      • Kingston, Other, Jamaica, 007
        • Recruiting
        • University of the West Indies, Mona
        • Contact:
        • Sub-Investigator:
          • Chelsea Roye, MBBS
        • Sub-Investigator:
          • Jheanelle Foster, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Participants with tinea versicolor who will have a treatment site selected. We will leave untreated areas to serve as "internal controls". Participants will apply cream to the designated areas but leave non-designated untreated. At follow up visits we will do fungal scrapings, visual examination and Wood's lamp evaluation of treatment and non-treatment areas
Drug: 20% 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion Clearance
Time Frame: 12 weeks
Proportion of participants with no visible lesions on which treatment applied. We will visually compare to baseline images and untreated skin
12 weeks
Fungal load
Time Frame: 12 weeks
Change in the fungal load on skin scraping. We will looks for decrease in positivity and density in treated skin compared with baseline and untreated control skin
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local skin reactions
Time Frame: 12 weeks
Proportion of participants with new skin reactions (burning, pain, pruritus, blisters, color change)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of The West Indies

Investigators

  • Principal Investigator: Jonathan D Ho, MBBS, D.Sc, The University of the West Indies, Mona Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC-MN.29, 2021/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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