Pityriasis Versicolor, Tinea Versicolor
Conditions
Keywords
Tinea Versicolor,, Cassia alata extract, Pityriasis versicolor
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.
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.
Interventions
DRUG20% Cassia alata cream
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
Sponsors
The University of The West Indies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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 cream including * No history of allergy to C. alata * No history of preservative allergy
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Clearance | 12 weeks | Proportion of participants with no visible lesions on which treatment applied. We will visually compare to baseline images and untreated skin |
| Fungal load | 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local skin reactions | 12 weeks | Proportion of participants with new skin reactions (burning, pain, pruritus, blisters, color change) |
Countries
Jamaica
Contacts
Primary ContactMarvin Reid, MB Bs PhD
Outcome results
None listed