A clinical study to assess the efficacy and safety of Naftifine cream in patients with superficial fungal infection of ski

Phase 3

• Conditions: Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue

• Registration Number: CTRI/2022/03/041466
• Lead Sponsor: Zydus Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

1. Patients with history of hypersensitivity to naftifine or terbinafine

2. Patients with extensive or disseminated tinea infections

3. Patients with tinea infection other than tinea corporis or tinea cruris such as tinea infection of face, scalp or feet

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