Clinical trial NCT05730244: A Study of the Clinical Efficacy and Safety of 100% Cassia Alata Extract Against Tinea Versicolor
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Tinea Versicolor
Keywords: Tinea Versicolor,
Cassia alata extract
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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
* 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

Primary outcomes:
measure: Lesion Clearance
timeFrame: 12 weeks
measure: Fungal load
timeFrame: 12 weeks
Secondary outcomes:
measure: painful skin reaction
timeFrame: 12 weeks
measure: Blistering skin lesion
timeFrame: 12 weeks
measure: Itching or Redness
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kingston
country: Jamaica
facility: University of the West Indies, Mona
state: Other
Study officials:
affiliation: Univeristy of the West Indies
name: Johnathan Ho, MB BS Dr Sc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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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.
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.
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.