Senna Alata Leaf Decoction as a Treatment for Tinea Imbricata
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|ClinicalTrials.gov Identifier: NCT03745183|
Recruitment Status : Completed
First Posted : November 19, 2018
Last Update Posted : November 19, 2018
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Background: Tinea imbricata ("tokelau") is a rare form of tinea corporis which is caused by Trichophyton concentricum. It is endemic among the T'boli tribe in Sarangani, Philippines . Temporary remissions, despite antifungal treatment, can be attributed to factors such as genetic susceptibility, widespread poverty, poor hygienic conditions and overcrowding. Limited access to commercial antifungal medications makes the treatment of tinea imbricata a pressing public health concern.
Senna alata grows abundantly in the areas where the T'boli tribe resides. Anecdotal reports about its efficacy as a treatment for tinea imbricata exist and need to be further validated.
Objective: This study aims to assess the efficacy and safety of a community-prepared Senna alata leaf decoction in the treatment of tinea imbricata.
Methods: This study is a preliminary open label, before and after clinical trial. Enrolled patients were taught how to make Senna alata leaf decoction and were asked to apply it as a leave-on body wash once a day for 28+/-3 days. Disease severity, pruritus visual analogue scale scores (VAS) and potassium hydroxide smear (KOH) of the skin scrapings were evaluated before and after treatment. Two separate assessors evaluated post treatment severity based on standard photographs. Diagnostic concordance was determined using Cohen's kappa statistics. Wilcoxon paired signed-rank test was used to analyzed before and after clinical parameter scores. Adverse drug events were recorded.
|Condition or disease||Intervention/treatment||Phase|
|Tinea Imbricata||Other: Senna alata leaf decoction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study is a preliminary open label, single arm, before and after clinical trial, that utilized Akapulko (Senna alata),a medicinal plant, leaf decoction in the treatment of tinea imbricata. Enrolled, who were recruited during the outreach mission were taught how to make a community-prepared akapulko decoction and were asked to apply it as a leave-on body wash once a day for 28+/-3 days.|
|Masking:||None (Open Label)|
|Official Title:||Senna Alata Leaf Decoction as a Treatment for Tinea Imbricata in an Indigenous Tribe in Southern Philippines :a Pilot Study|
|Actual Study Start Date :||November 2014|
|Actual Primary Completion Date :||January 15, 2015|
|Actual Study Completion Date :||January 15, 2015|
Experimental: Senna alata leaf decoction
The participants were instructed to take a bath once a day using a syndet bar and to towel dry their skin before applying the akapulko decoction. Fresh decoction was prepared by the patients every day. After a bath, the patient applied the fresh cooled decoction by hand on the whole body especially on the affected areas and left it to dry. Approximately one glassful (350ml) of akapulko decoction should be consumed for one whole body application. The total duration of daily application should be 4 weeks (28 days +3) until the next outcome assessment.The patients were given illustrated, laminated instructional materials and a tabulated checklist of instructions on how to prepare and apply the decoction which served as a monitoring sheet of each patient.
Other: Senna alata leaf decoction
Preparation of the akapulko decoction
- Improvement in disease severity [ Time Frame: Before and after the treatment period of 1 month ]
Disease severity was measured by body surface area of involvement, erythema and scaling . After which, their composite scores were combined and graded no disease, mild, moderate and severe.
Body surface area of involvement grading Score Characteristic 0 No lesions
- Lesions occupy an aggregate surface area less than or equal to 5cm x 5cm
- Aggregate surface area greater than 5cm x 5cm but less than 10cm x 10cm
- Aggregate surface area of greater than 10cm x 10cm
Erythema grading Score Characteristic 0 No erythema
- Nearly imperceptible erythema
- Moderate erythema (pinkish skin)
- Intense erythema
Scaling grade Score Characteristic 0 No scaling
- Fine white scales
- Moderate scales
- Large scales
Composite Scores Category Score No disease 0 Mild For composite score of 1-3 Moderate For composite score of 4 -6 Severe For composite score of 7- 9
- Adverse Events [ Time Frame: Before and after the treatment period of 1 month ]Presence of adverse drug effects were noted. Subjects were instructed to report to the research assistants or to the local health center in case any of these adverse drug events occurred for proper management. Participants with mild to severe adverse drug effects were withdrawn from the study and provided appropriate management by the investigators.
- Improvement in pruritus visual analogue scale scores [ Time Frame: Before and after the treatment period of 1 month ]The visual analogue scale is a 10-cm long line oriented horizontally or vertically used to indicate the patient's intensity of pruritus by crossing the line at the point the corresponds to the patient's pruritus severity. The patients' pruritus was assessed using the VAS scale in which the patients were instructed to select a point along the 10-cm line for his/her assessment, with "0" meaning no pruritus and "10" meaning the most severe pruritus they can imagine.
- potassium hydroxide smear conversion [ Time Frame: Before and after the treatment period of 1 month ]Potassium hydroxide mount (KOH) test of the lesions were done before , where in KOH 10% reagent dropped on the skin scales to confirm the presence of fungal infection by microscopic examination.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Indigenous T'boli patient aged 18 years old and above, male or female
- Patients with clinically diagnosed tinea imbricata with microscopically confirmed skin scraping positive for potassium hydroxide (KOH)
- Patients who were treated or undergoing treatment with topical anti-fungal for 2 weeks or oral anti-fungal 1 month before the study
- Patients who were taking other systemic medications such as cytotoxic and immunosuppressive drugs
- Patients with known liver disease, kidney dysfunction, hematologic problems (e.g. anemia)
- Patients with or suspected allergy to Senna alata extract
The participation of the subjects were completely voluntary. Participants were allowed to withdraw from the study at anytime and for any reason without prejudice to their subsequent medical treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745183
|Principal Investigator:||Kathleen E Alpapara, MD||Philippine Dermatological Society|
|Study Director:||Belen L Dofitas, MD||Philippine Dermatological Society|
Publications of Results:
|Responsible Party:||Philippine Dermatological Society|
|Other Study ID Numbers:||
|First Posted:||November 19, 2018 Key Record Dates|
|Last Update Posted:||November 19, 2018|
|Last Verified:||November 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Bacterial Infections and Mycoses
Skin Diseases, Infectious