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Tinea VersicolorPhase 1NCT05730244

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

A Phase 1 study testing 20% Cassia alata cream in people with Tinea Versicolor and Pityriasis Versicolor, run by The University of The West Indies at 1 site in Jamaica.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Tinea Versicolor, Pityriasis Versicolor
What is being tested?
20% Cassia alata cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteJamaica
Study dates
1 Mar 2025to 30 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marvin Reid, MB Bs PhD contact

8763812939

marvin.reid@uwimona.edu.jm

Jamaica1 site, 1 recruiting

  • University of the West Indies, Mona

    Kingston, Other, 007

    Marvin Reid, MB BS, 8769271884, marvin.reid@uwimona.edu.jm

    Chelsea Roye, MBBS

    Recruiting

Other trials in Jamaica

About this study

Official title: 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.

Read the 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.

Being tested
20% Cassia alata cream
Keywords
Tinea Versicolor,, Cassia alata extract, Pityriasis versicolor
Medical subject headings
Tinea Versicolor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 20% Cassia alata creamDrug

    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

Study groups in NCT05730244
Study groupRoleWhat they receive
TreatmentExperimentalParticipants 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
Receives: Drug: 20% Cassia alata cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lesion Clearance

    Proportion of participants with no visible lesions on which treatment applied. We will visually compare to baseline images and untreated skin

    Measured: 12 weeks

  2. Fungal load

    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

    Measured: 12 weeks

Secondary outcomes (1)

  1. Local skin reactions

    Proportion of participants with new skin reactions (burning, pain, pruritus, blisters, color change)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2023
  2. Study start1 Mar 2025
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A self-controlled trial pilot study evaluating the clinical efficacy and safety profile of 20% Cassia alata cream against tinea versicolor. Single group, all with tinea versicolor. Selected area treated, untreated areas serve as internal control. Assessment using background spontaneous clearance data and internal control comparison from non-treated areas
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05730244
Sponsor's protocol ID
CREC-MN.29, 2021/2022
Status last verified
Nov 2025
First submitted
6 Feb 2023
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kallini JR, Riaz F, Khachemoune A. Tinea versicolor in dark-skinned individuals. Int J Dermatol. 2014 Feb;53(2):137-41. doi: 10.1111/ijd.12345. Epub 2013 Dec 10.

    PubMed 24320140

  • Gupta AK, Lyons DC. Pityriasis versicolor: an update on pharmacological treatment options. Expert Opin Pharmacother. 2014 Aug;15(12):1707-13. doi: 10.1517/14656566.2014.931373. Epub 2014 Jul 3.

    PubMed 24991691

  • Palanichamy S, Nagarajan S. Antifungal activity of Cassia alata leaf extract. J Ethnopharmacol. 1990 Jul;29(3):337-40. doi: 10.1016/0378-8741(90)90043-s. No abstract available.

    PubMed 2214817

  • Agarwal SK, Singh SS, Verma S, Kumar S. Antifungal activity of anthraquinone derivatives from Rheum emodi. J Ethnopharmacol. 2000 Sep;72(1-2):43-6. doi: 10.1016/s0378-8741(00)00195-1.

    PubMed 10967452

  • Barros Cota B, Batista Carneiro de Oliveira D, Carla Borges T, Cristina Catto A, Valverde Serafim C, Rogelis Aquiles Rodrigues A, Kohlhoff M, Leomar Zani C, Assuncao Andrade A. Antifungal activity of extracts and purified saponins from the rhizomes of Chamaecostus cuspidatus against Candida and Trichophyton species. J Appl Microbiol. 2021 Jan;130(1):61-75. doi: 10.1111/jam.14783. Epub 2020 Jul 29.

    PubMed 32654270

  • Zhang D, Fu Y, Yang J, Li XN, San MM, Oo TN, Wang Y, Yang X. Triterpenoids and Their Glycosides from Glinus Oppositifolius with Antifungal Activities against Microsporum Gypseum and Trichophyton Rubrum. Molecules. 2019 Jun 12;24(12):2206. doi: 10.3390/molecules24122206.

    PubMed 31212847

  • Damodaran S, Venkataraman S. A study on the therapeutic efficacy of Cassia alata, Linn. leaf extract against Pityriasis versicolor. J Ethnopharmacol. 1994 Mar;42(1):19-23. doi: 10.1016/0378-8741(94)90018-3.

    PubMed 8046939

  • Thamlikitkul V, Bunyapraphatsara N, Dechatiwongse T, Theerapong S, Chantrakul C, Thanaveerasuwan T, Nimitnon S, Boonroj P, Punkrut W, Gingsungneon V, et al. Randomized controlled trial of Cassia alata Linn. for constipation. J Med Assoc Thai. 1990 Apr;73(4):217-22.

    PubMed 2203870

  • Kaneko T, Makimura K, Onozaki M, Ueda K, Yamada Y, Nishiyama Y, Yamaguchi H. Vital growth factors of Malassezia species on modified CHROMagar Candida. Med Mycol. 2005 Dec;43(8):699-704. doi: 10.1080/13693780500130564.

    PubMed 16422299

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 20% Cassia alata cream in people with Tinea Versicolor and Pityriasis Versicolor, run by The University of The West Indies at 1 site in Jamaica.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marvin Reid, MB Bs PhD (8763812939, marvin.reid@uwimona.edu.jm), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lesion Clearance (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05730244, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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