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

NCT05730244 | Recruiting Phase 1

• 1 other identifier: CREC-MN.29, 2021/2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tinea Versicolor; Pityriasis Versicolor

Keywords

Tinea Versicolor,; Cassia alata extract; Pityriasis versicolor

Outcome Measures

Primary Outcomes (2)

• Lesion Clearance

  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

  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 Outcomes (1)

• Local skin reactions

  12 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

20% Cassia alata cream DRUG

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

Treatment

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

University of the West Indies, Mona

Kingston, Other, 007, Jamaica

RECRUITING

Related Publications (9)

• 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.

  PMID: 24320140 BACKGROUND

• 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.

  PMID: 24991691 BACKGROUND

• 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.

  PMID: 2214817 BACKGROUND

• 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.

  PMID: 10967452 BACKGROUND

• 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.

  PMID: 32654270 BACKGROUND

• 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.

  PMID: 31212847 BACKGROUND

• 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.

  PMID: 8046939 BACKGROUND

• 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.

  PMID: 2203870 BACKGROUND

• 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.

  PMID: 16422299 BACKGROUND

MeSH Terms

Conditions

Tinea Versicolor

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jonathan D Ho, MBBS, D.Sc

  The University of the West Indies, Mona Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marvin Reid, MB Bs PhD

CONTACT

8763812939; marvin.reid@uwimona.edu.jm

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: March 1, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

JA (1)