Health Condition 1: null- Inflamed Cutaneous Mycoses
Conditions
Interventions
Intervention1: Combination product of Eberconazole1% and Mometasone 0.1% cream:
Control Intervention1: NIL: Not applicable
Sponsors
Dr Reddys Laboratories Ltd Hyderabad India
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients of both genders aged between 18 and 65 years,who have signed informed consent Must have a clinical diagnosis of Cutaneous mycoses supported by mycological diagnosis. Total score of at least 3 on the scale of objective evaluation of severity of signs and symptoms. Both male and female patients should use contraceptive measures to avoid pregnancy during the treatment period. No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs. No other concurrent uncontrolled illness No psychiatric illness or social situation that would preclude study compliance If the patient is female; ? She must be of non-childbearing potential, i.e., surgically sterilized, or ? Must be negative on pregnancy test before starting therapy and must agree to continue such precautions thereafter for another one month If the subject has received the antifungal treatment for Cutaneous mycoses, then a washout period of 30 days for systemic antifungal drugs and 2 weeks for topical antifungal agents has to be observed.
Exclusion criteria
Exclusion criteria: 1. Patients <18 and >66 years of age 2. Pregnant and lactating women 3. The subjects with Onychomycosis, Mocassin type, keratotic feet. 4. Life-threatening or serious cardiac diseases like cardiac failure/insufficiency (NYHA grades III-IV), respiratory, gastrointestinal, hepatic, renal, endocrine, Compromised circulation or immunologic disorder 5. Uncontrolled Hypertension 6. Uncontrolled Diabetes Mellitus 7. Any confirmed or suspected immunosuppressive or immuno- deficient condition 8. Clinically relevant abnormal hematology or biochemistry values, in the opinion of the Investigator ? Creatinine level &#8805; 2 times of upper limit of normal ? Bilirubin &#8805; 1.5 times of ULN ? Serum transaminases (ALT, AST) &#8805;3 times of ULN 9. Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug, ; 10. Have used systemic antifungal drugs within 30 days of first dose; or topical antifungal within 2 weeks of first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete cure (negative mycology and clinical cure) rate at day 21Timepoint: at day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety of Eberconazole +Mometasone 2. Clinical cure rate at day 35Timepoint: Day 35 | — |
Countries
India
Contacts
Public ContactDr M S Latha
Outcome results
None listed