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

February 17, 2023 updated by: The University of The West Indies

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

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.

Study Overview

Status

Not yet 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: 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.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Locations

  • Jamaica
    • Other
      • Kingston, Other, Jamaica, 007
        • University of the West Indies, mona

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

Genders Eligible for Study

All

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 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

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
12 weeks
Fungal load
Time Frame: 12 weeks
Change in the fungal load on skin scrapping
12 weeks

Secondary Outcome Measures

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

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 (Anticipated)

February 15, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

June 30, 2024

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 (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

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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