A Study of the Clinical Efficacy and Safety of 100% Cassia Alata Extract Against Tinea Versicolor
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Lesion Clearance [12 weeks]
Proportion of participants with no visible lesions on which treatment applied
- Fungal load [12 weeks]
Change in the fungal load on skin scrapping
Secondary Outcome Measures
- painful skin reaction [12 weeks]
Proportion of participants with painful lesion on which treatment applied
- Blistering skin lesion [12 weeks]
Proportion of participants with blistering of lesion on which treatment applied
- Itching or Redness [12 weeks]
Proportion of participants with icthing or redness of lesion on which treatment applied
Eligibility Criteria
Criteria
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
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No treatment for versicolor in the preceding 4 weeks
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No contraindications to the application of C.alata extract in solution including
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No history of allergy to C. alata
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No history of preservative allergy
-
No history of allergy to adhesives/tapes
Exclusion Criteria:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of the West Indies, Mona | Kingston | Other | Jamaica | 007 |
Sponsors and Collaborators
- The University of The West Indies
Investigators
- Principal Investigator: Johnathan Ho, MB BS Dr Sc, Univeristy of the West Indies
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- CREC-MN.29, 2021/2022