A randomized, double-blind, clinical trial on the effectiveness and safety of 50% Gliricidia sepium (Kakawate/Madre de Cacao) ointment compared with 2% miconazole ointment in the treatment of tinea corporis and tinea cruris (a pilot study)

BACKGROUND: Tinea corporis and tinea cruris are among the most common skin diseases in tropical countries like the Philippines. Topical antifungal agents, although the first line treatment, are often expensive and unaffordable. Thus, an emerging interest on the therapeutic effects of herbal medicines is currently on the rise. OBJECTIVE: To determine the effectiveness and safety of 50 percent Gliricidia sepium (Kakawate/Madre de Cacao) ointment versus 2 percent miconazole ointment in the treatment of tinea corporis and tinea cruris. METHODS: Patients (n = 40) were randomly allocated to apply kakawate ointment or miconazole ointment twice daily on the affected areas for 3 weeks with weekly follow-up periods. The patients and investigators were blinded as to the treatment allocation. Outcomes assessed were mycologic cure (negative potassium hydroxide mount), adverse events, total signs and symptoms score, effective clinical response based on investigator's global response assessment (IGRA) and patient's assessment. Comparisons were done both on per protocol and intention-to-treat bases. RESULTS: On both per protocol and intention-to-treat (ITT) analyses, mycologic cure and development of adverse events between kakawate and miconazole ointments showed no significant statistical difference [p-0.10 and p=0.04 (ITT), respectively]. Both treatment groups had significant reduction in total signs and symptoms score from baseline to week 3 (p <0.001). Nevertheless, miconazole had greater reduction with a p value of <0.02 (ITT). In terms of IGRA and patient's assessment, there were significant improvements within each group with a p value of <0.001 and 0.005 (ITT), respectively. However, the miconazole group still had higher IGRA scores and had better assessments compared to the kakawate group [p=0.001 and p=0.012 (ITT), respectively]. CONCLUSION: 50 percent Gliricidia sepium ointment is comparable with 2 percent miconazole ointment in terms of mycologic cure and safety profile, but it is not as effective as 2 percent miconazole ointment in improving overall clinical response and reducing major signs and symptoms of tinea corporis and cruris.