Senna Alata Leaf Decoction as a Treatment for Tinea Imbricata

NCT03745183 | Completed DMC

• 1 other identifier: PDS_PGH_2017_002
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tinea Imbricata

Keywords

tinea imbricata; Senna alata

Outcome Measures

Primary Outcomes (1)

• Improvement in disease severity

  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 1. Lesions occupy an aggregate surface area less than or equal to 5cm x 5cm 2. Aggregate surface area greater than 5cm x 5cm but less than 10cm x 10cm 3. Aggregate surface area of greater than 10cm x 10cm Erythema grading Score Characteristic 0 No erythema 1. Nearly imperceptible erythema 2. Moderate erythema (pinkish skin) 3. Intense erythema Scaling grade Score Characteristic 0 No scaling 1. Fine white scales 2. Moderate scales 3. 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

  Before and after the treatment period of 1 month

Secondary Outcomes (1)

• Adverse Events

  Before and after the treatment period of 1 month

Other Outcomes (2)

• Improvement in pruritus visual analogue scale scores

  Before and after the treatment period of 1 month

• potassium hydroxide smear conversion

  Before and after the treatment period of 1 month

Study Arms (1)

Senna alata leaf decoction

EXPERIMENTAL

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

Interventions

Senna alata leaf decoction OTHER

Preparation of the akapulko decoction 1. Remove the leaflets from the rachis of a mature leaf. 2. Wash the mature leaflets thoroughly to remove dust, dirt and debris. 3. In the clay, enamel, or stainless steel pot, place one glassful of closely packed chopped leaves (350 ml glass) and add 2 glasses (around 700ml) of clean water . Use the same glass for measuring the leaves and water. 4. Cook the leaves and bring to a rolling boil. 5. When the fluid is reduced to half, remove the decoction from the fire and cool slightly. 6. Strain the mixture using cheesecloth and press the cut leaves in the strainer to make sure to get as much liquid out of them. 7. Place the liquid in a clean container (bottle/jar with cover). Label the container clearly as "Akapulko".

Senna alata leaf decoction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philippine Dermatological Society: lead

Related Publications (15)

• Pihet M, Bourgeois H, Maziere JY, Berlioz-Arthaud A, Bouchara JP, Chabasse D. Isolation of Trichophyton concentricum from chronic cutaneous lesions in patients from the Solomon Islands. Trans R Soc Trop Med Hyg. 2008 Apr;102(4):389-93. doi: 10.1016/j.trstmh.2008.01.002. Epub 2008 Mar 4.

  PMID: 18295290 BACKGROUND

• FERNANDEZ MC, JAO RL. Tinea imbricata successfully treated with griseofulvin. Report of a case. Arch Dermatol. 1962 Jul;86:65-7. doi: 10.1001/archderm.1962.01590070071011. No abstract available.

  PMID: 13892414 BACKGROUND

• Havlickova B, Czaika VA, Friedrich M. Epidemiological trends in skin mycoses worldwide. Mycoses. 2008 Sep;51 Suppl 4:2-15. doi: 10.1111/j.1439-0507.2008.01606.x.

  PMID: 18783559 BACKGROUND

• CHERMSIRIVATHANA S, BOONSRI P. A case of tinea imbricata (Hanumarn ringworm) treated with fulcin. Aust J Dermatol. 1961 Jun;6:63-6. doi: 10.1111/j.1440-0960.1961.tb01331.x. No abstract available.

  PMID: 13878721 BACKGROUND

• Bonifaz A, Araiza J, Koffman-Alfaro S, Paredes-Solis V, Cuevas-Covarrubias S, Rivera MR. Tinea imbricata: autosomal dominant pattern of susceptibility in a polygamous indigenous family of the Nahuatl zone in Mexico. Mycoses. 2004 Aug;47(7):288-91. doi: 10.1111/j.1439-0507.2004.00989.x.

  PMID: 15310331 BACKGROUND

• Bonifaz A, Archer-Dubon C, Saul A. Tinea imbricata or Tokelau. Int J Dermatol. 2004 Jul;43(7):506-10. doi: 10.1111/j.1365-4632.2004.02171.x.

  PMID: 15230889 BACKGROUND

• Hemen, Dave and Ledwani, Lalita. A review on anthraquinones isolated from Cassia species and their applications. Indian Journal of Natural Products and Resources. September 2012. Vol. 3 (3), pp.291-319

  BACKGROUND

• Núñez Montoya, S.C., Comini L.R., and Cabrera J.L.. Antimicrobial activity of natural photosensitizing anthraquinones. Science against microbial pathogens: communicating current research and technological advances. Department of Pharmacology. 2011. pp 3-13

  BACKGROUND

• Okwu, D.E. and Nnamdi, F.U.Cannabinoid Dronabinol alkaloid with antimicrobial activity from Cassia alata Linn. Der Chemica Sinica. 2011. Vol 2(2): 247-254

  BACKGROUND

• Philippine Health Research Board. National Ethical Guidelines for Health Research. 2011.pp 54-58 and 91-96.

  BACKGROUND

• National Administrative Order No. 3 " The Revised Guidelines and Prior Informed Consent (FPIC) and Related Processes f 2012"

  BACKGROUND

• Duke, James. Duke's Handbook of Medicinal Plants of the Bible. USA: CRC Press, 2007.

  BACKGROUND

• Wingfield AB, Fernandez-Obregon AC, Wignall FS, Greer DL. Treatment of tinea imbricata: a randomized clinical trial using griseofulvin, terbinafine, itraconazole and fluconazole. Br J Dermatol. 2004 Jan;150(1):119-26. doi: 10.1111/j.1365-2133.2004.05643.x.

  PMID: 14746625 RESULT

• Dofitas BL and Non BL., Tinea Imbricata: Case Series on Three Patients in Sarangani, Philippines. Acta Medica Philippina. 44(3). (2010)

  RESULT

• Carpio, V , Dofitas, B and Frez, L. (2010). Blekis: Tinea imbricata in Sarangani, Philippines.Unpublished manuscript.

  RESULT

Study Officials

• Kathleen E Alpapara, MD

  Philippine Dermatological Society

  PRINCIPAL INVESTIGATOR

• Belen L Dofitas, MD

  Philippine Dermatological Society

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: November 19, 2018
• Study Start: November 1, 2014
• Primary Completion: January 15, 2015
• Study Completion: January 15, 2015
• Last Updated: November 19, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share