Health Trials

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

ConditionsTinea VersicolorPityriasis Versicolor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-89
SponsorThe University of The West Indies

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age <18 or >89 years

Pregnant females

History of hypersensitivity to C. alata or preservative

Treatment within 4 weeks prior to enrollment

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 groups

20 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Lesion Clearance

Proportion of participants with no visible lesions on which treatment applied. We will visually compare to baseline images and untreated skin

Time frame
12 weeks
2

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

Time frame
12 weeks

Secondary outcomes

1

Local skin reactions

Proportion of participants with new skin reactions (burning, pain, pruritus, blisters, color change)

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of The West Indies

Lead sponsor

Source ClinicalTrials.gov
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