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

Tinea Versicolor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05730244
• Other study ID #: CREC-MN.29, 2021/2022
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 15, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2023
• Source: The University of The West Indies
• Contact: Marvin Reid, MB Bs PhD
• Phone: 8763812939
• Email: marvin.reid[@]uwimona.edu.jm
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinea
• Tinea Versicolor

Intervention

Drug:
• Cassia alata extract
1 ml Cassia alata extract
• Placebo
1 ml placebo solution

Locations

Country	Name	City	State
Jamaica	University of the West Indies, Mona	Kingston	Other

Sponsors (1)

Lead Sponsor	Collaborator
The University of The West Indies

Country where clinical trial is conducted

Jamaica, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion Clearance	Proportion of participants with no visible lesions on which treatment applied	12 weeks
Primary	Fungal load	Change in the fungal load on skin scrapping	12 weeks
Secondary	painful skin reaction	Proportion of participants with painful lesion on which treatment applied	12 weeks
Secondary	Blistering skin lesion	Proportion of participants with blistering of lesion on which treatment applied	12 weeks
Secondary	Itching or Redness	Proportion of participants with icthing or redness of lesion on which treatment applied	12 weeks