Dermatophytosis. Dermatophytosis
Conditions
Interventions
Intervention 1: Intervention group: treatment with DermatoTreat spray. Patients receive the developed Dermatotrit spray containing 1% Terbinafine Hydrochloride manufactured by Parsa Biotechnology Bio
Sponsors
Shiraz University of Medical Sciences
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All the dermatophytosis patients who were diagnosed by physical exam by doctor or by routine mycological methods Availability for the duration of the study (6 weeks) Male or female, 18 years or older Willingness to follow the study protocol Not taking systemic antifungal drugs in the last month Not using topical anti-fungal drugs or anti-fungal shampoo in 2 weeks before treatment Insensitivity to terbinafine Informed consent
Exclusion criteria
Exclusion criteria: Moccasin-type tinea pedis Tinea capitis , tinea with an area of more than 20% of the body Tinea resistant to previous treatments including oral treatment and Tinea incognito Severe maceration of interdigital spaces Severe fissuring Prescribing or taking oral antifungal medication in the two weeks before or during the study History of dry feet, cracks, fissures Concomitant onychomycosis Serous discharge or pus Concomitant immunosuppressive or antimicrobial therapy Failure to respond to treatment Drug allergy Failure to cooperate with the doctor Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective treatment (fungal treatment and minimal symptoms). Timepoint: In the beginning, 1, 2 and 4 weeks after the initiation of therapy. Method of measurement: Microscopic examination (direct smear exam) and clinical evaluation that is based on a total of 6 symptoms (skin peeling, vesiculation, erythema, fissure, soaking and itching) which is recorded by the physician. | — |
Secondary
| Measure | Time frame |
|---|---|
| The amount of side effects. Timepoint: In the beginning, 1, 2 and 4 weeks after beginning of therapy. Method of measurement: To check the safety of the treatment, we will calculate the amount of side effects as well as serious side effects and compare them between the two arms of the study using chi-square tests to check if there is a statistically significant difference or not.;Effective treatment (fungal treatment and minimal symptoms). Timepoint: 4 weeks after beginning of therapy. Method of measurement: Negative mycological microscopic test (direct) and clinical evaluation that is based on a total of 6 symptoms (skin peeling, vesiculation, erythema, fissure, soaking and itching) which is recorded by the doctor.;Patient satisfaction score. Timepoint: At the end of the treatment period. Method of measurement: Patients complete a short survey in the form of a questionnaire about their perception of the tolerability, effectiveness and comfort of the treatment on a five-point scale, where 1 = poor, 2 = fair, 3 = good, 4 = very good, 5 = great, or they may respond with "no answer/prefer not to say". Scores for each treatment will be calculated and compared.;Self-reported patient compliance. Timepoint: At the end of the treatment period. Method of measurement: In the questionnaire, patients are asked to estimate how many doses they have missed. Possible answers include none, 1-2, 3-4, 5-6, 7-8, or 9 or more. It shows whether there is a significant difference in the probability of adherence of patients to a treatment regimen or not. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKamiar Zomorodian
Shiraz University of Medical Sciences
Outcome results
None listed