Non-inferiority Trial of Dapaconazole Versus Ketoconazole

Inclusion Criteria:

• Participants aged from 18 to 65 years old, male, or female with no childbearingpotential or who are using an effective contraceptive method and who do not plan tobecome pregnant during the study period.

• Presence of dermatological lesion(s) of Tinea pedis, with a global clinical severityscore ≥ 4, being a minimum score of 2 for itching or desquamation/maceration and aminimum score of 2 for erythema, having, also, the diagnosis confirmed by directmycological (KOH) test.

• No previous treatment with antimycotic medication, in the last 2 months, for thecurrent dermatologic lesion.

• No evidence of other significant diseases, that, at the investigator's discretion, mayaffect the participation in the clinical trial, in accordance with the protocolrequirements.

• Ability to understand the nature and the objective of the clinical trial, includingthe risks and possible side effects; intention to cooperate with the investigator andact in accordance with the protocol requirements, as confirmed by the informed consentform signature.

Exclusion Criteria:

• Existing hepatic and/or renal diseases or other pathologic findings, which mightinterfere with the safety and tolerability of the active ingredients.

• Screening laboratory tests presenting deviations deemed as clinically significant,which, due to possible risks, prevents the participation in clinical trial.

• Known hypersensitivity to ketoconazole or to chemically related compounds (azoles) orto the compounds of the investigational products.

• Participants with severe or multiple drugs allergies, unless judged by theinvestigator as not clinically relevant to the participation in the clinical trial.

• Positive anti human immunodeficiency virus (anti-HIV) test, positive Hepatitis BSurface Antigen (HBs-Ag) test or positive anti hepatitis C virus (anti-HCV) test.

• Treatment, within 3 months prior to the start of the clinical trial treatment, withany drug known to have a well-established toxic potential to major organs.

• Pregnant or lactating women

• Participation in any clinical trial, or intake of any investigational product, withinthe last twelve months prior to the inclusion in the clinical trial.

• Presence of onychomycosis.

• Presence of "Moccasin type" Tinea pedis.

• Presence of infected Tinea pedis, or any other infection or pathology that may confusethe treatment evaluation.

• History of drug addiction.

• Diseases that may alter the immune system and, consequently, the host's response tothe fungal presence (immunosuppressed participants), as well as the use of systemicimmunosuppressive drugs, chemotherapy or radiotherapy, during the 3 months prior tothe start of treatment.

• Use of drugs that may interfere with the assessment of the results, as well as use oftopical immunosuppressants, topical antibiotics or topical corticosteroids, within 2months prior to the start of treatment.

• Use of antipruriginous drugs, including antihistaminics, within 72 hours prior to thestart of treatment.

• History of alcohol dependence and/or regular intake of alcoholic food or beveragescontaining ≥ 20 g of pure ethanol per day.

• Any prior treatment for the present lesion which, at investigator discretion, mayinterfere with the objectives of the clinical trial.

• Participants who might be non-compliant to the study treatment and/or to therequirements and procedures of the protocol.

• Participants who are unable to understand written and verbal instructions, inparticular those regarding the risks and inconveniences to which they will be exposedduring the participation in the clinical trial.