Clinical study to assess the efficacy and safety of Amorolfine lotion compared to Amorolfine cream in patients with superficial fungal infection of the ski
- Conditions
- Health Condition 1: L00-L99- Diseases of the skin and subcutaneous tissue
- Registration Number
- CTRI/2020/09/027948
- Lead Sponsor
- Zydus Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 284
1. Patients of either gender of 18 to 65 years of age (both inclusive)
2. Patients with acute symptomatic tinea corporis or tinea cruris limited to single body region and with limited involvement i.e., < 5 skin lesions with each having greatest diameter of < 5 cm
3. Mycological diagnosis of tinea corporis or tinea cruris confirmed by detection of fungal hyphae on a microscopic KOH test
4. Patients with total clinical score of at least 5
5. Patients willing to provide written informed consent and comply with the protocol requirements
1. Patients with history of hypersensitivity to amorolfine
2. Patients with extensive or disseminated tinea infections
3. Patients with tinea infection other than tinea corporis or tinea cruris
4. Patients with diagnosis of tinea infection requiring systemic treatment according to the severity of lesion as judged by the investigator
5. Patients having skin lesions with secondary bacterial infection
6. Patients with other dermatological conditions which may confound the disease assessment and treatment evaluation e.g., contact dermatitis, atopic dermatitis, psoriasis, urticaria
7. Patients with clinically significant uncontrolled systemic diseases such as gastrointestinal, cardiovascular, renal, neurological, psychiatric, endocrine or hematological disorders or malignancy
8. Patients with immunosuppressive disorder e.g., HIV infection or patients on immunosuppressive medications e.g., systemic corticosteroids or cytotoxic drugs
9. Patients with hepatic dysfunction (serum transaminases � 3 x Upper Normal Limit) or renal dysfunction (serum creatinine � 2.5 mg/dl)
10. Patients who have used the following medications:
a. Topical antifungal agent within 30 days prior to enrollment
b. Systemic antifungal agent within 8 weeks (8 months for oral terbinafine) prior to enrollment
c. Topical corticosteroid on the affected area(s) within 30 days prior to enrollment
d. Systemic corticosteroids within 30 days prior to enrollment
e. Systemic antihistamine agent within 3 days prior to enrollment
f. Any other topical treatment on the affected area(s) within 7 days prior to enrollment
11. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
12. Patients with history of alcohol and/or drug abuse
13. Participation in another clinical trial in the past 3 months prior to screening
14. Any other reason for which the investigator feels that the patient should not participate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical cure at the end of the treatmentTimepoint: Day 28
- Secondary Outcome Measures
Name Time Method Clinical and mycological relapse during the post-treatment follow-upTimepoint: Day 42;Composite cure at the end of the treatmentTimepoint: Day 28;Global assessment of efficacy at the end of the treatmentTimepoint: Day 28;Mycological cure at the end of the treatmentTimepoint: Day 28