Clinical trial: Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis (NCT02582177)

Eligibility criteria:
Inclusion Criteria:

          -  Ability to understand and consent to participate in this clinical research, expressed
             by signing the Informed Consent Form (ICF);

          -  Participants with moderate or severe clinical diagnosis of superficial mycoses caused
             by Candida ssp or following fungal /dermatophytosis infections: inflammatory tinea
             corporis inflammatory (except face), inflammatory tinea cruris and inflammatory tinea
             pedis, with confirmation through direct mycological examination. In moderate or severe
             superficial mycosis that present at least moderate erythema and itching signs and
             slight peeling according to the evaluation by the four-point category scale (0=absent,
             1-mild, 2-moderate, 3-severe);

        Exclusion Criteria:

          -  Any observational finding (clinical/ physical evaluation) that is interpreted by the
             investigator as a risk to the research participant's participation in the clinical
             trial;

          -  Known hypersensitivity to the drug components used during the study;

          -  Use of prohibited drugs and treatment prohibited in the last 90 days;

          -  Immune impairment, according to investigator assessment;

          -  Vulvovaginal candidiasis diagnostics, balanopreputial, nail, chronic mucocutaneous or
             oral;

          -  Diagnosis of chickenpox, rosacea, herpes simplex or zoster, skin tuberculosis or skin
             syphilis, systemic fungal infection;

          -  Participants who, though they have studied diagnosis of fungal infections requiring
             systemic treatment according to the severity of injury and according to the opinion of
             the investigator;

          -  Participants that have skin lesions with clinical signs of bacterial infection;

          -  Participants who, according to investigator assessment, require systemic antibiotic
             treatment;

          -  Participants that are in any treatment , in the opinion of the investigator, may
             affect the results of the study;

          -  Participants diagnosed with HIV;

          -  Participants diagnosed with Diabetes Mellitus;

          -  Participants with a history of smallpox vaccine reaction;

          -  Women in gestation period or who are breastfeeding;

          -  Female participants who are in the reproductive age and do not agree to use acceptable
             methods of contraception (oral contraceptives, injectable contraceptives, intrauterine
             device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation);
             except surgically sterile (bilateral oophorectomy or hysterectomy), the menopausal for
             at least one year and participants who declare to perform sexual practices on a not to
             reproductive way;

          -  Participant who participated in clinical in the last twelve months, unless the
             investigator considers that there may be direct benefit to thereof;

          -  Participant has some kinship of second degree or bond with employees or employees of
             Sponsor and Research Center.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? Contradiction