To understand activity of formulation containing Lactoferrin cream and Luliconazole cream against Luliconazole Cream alone in treatment of skin fungal infections
- Conditions
- Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecified
- Registration Number
- CTRI/2024/03/063840
- Lead Sponsor
- Frimline Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patients will be included in the study if they meet all the following criteria:
1.Male or female patients aged between 18 to 65 years (both inclusive) with a clinical diagnosis of mycologically proven cutaneous candidiasis or dermatophytosis (Tinea/ Ringworm). Cutaneous candidiasis includes below-
A. Candidial folliculitis
B. Candidal intertrigo
C. Candidal paronychia
D. Perianal candidiasis
E. Candidid
F. Chronic mucocutaneous candidiasis
G. Congenital cutaneous candidiasis
H. Erosio interdigitalis blastomycetica
I. Candidial onychomycosis
Dermatophytosis includes
A. Tinea barbae
B. Tinea capitis
C. Tinea corporis
D. Tinea cruris
E. Tinea pedis
2. Patients with localized superficial fungal infection confirmed by the presence of fungal hyphae in KOH (potassium hydroxide) preparation of skin scrapings from over the lesion at screening visit
3. Patients agree not to use ƒany other topical product on the affected area during the entire course of study except for non-medicated, investigator-approved cleanser, and sunscreen. Patients should continue to use these investigator-approved products for the duration of the study and should avoid any changes in these consumer products.
4. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening/ baseline visit.
5. Patients with the ability to understand and provide a written informed consent form before the screening.
6. Patients willing to comply with the protocol requirements throughout the study.
Patients are excluded from the study if any of the following criteria apply
1. Patients with known or suspected hypersensitivity to quinolone antibacterial agents or azoles for example Ketoconazole.
2. Patients with the presence of any skin condition that would interfere with the diagnosis or assessment of cutaneous candidiasis.
3. Patients receiving treatment with the following products
a. Systemic antifungals for the treatment of cutaneous candidiasis in the 30 days before the baseline visit.
b. Any medication or procedure that, in the opinion of the investigator, would put the Patient at unacceptable risk for participation in the study or may interfere with evaluations in the study.
4. Patients with uncontrolled hypertension with sitting systolic BP 160 mmHg and or diastolic BP100 mmHg at screening.
5. Females who are pregnant or lactating or planning to become pregnant during the study period.
6. Patients with a history of experiencing significant burning or stinging when applying any topical treatment.
7. Patients with a serious and or chronic medical conditions.
8. Patients with a history of substance abuse or dependence that in the opinion of the Investigator considered interfering with the patients participation in the study.
9. Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days before signing informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effectiveness of Lactoferrin cream + Luliconazole cream in inhibiting biofilm formation compared to Luliconazole cream alone in patients suffering from cutaneous candidiasis and dermatophytosis.Timepoint: Day 14
- Secondary Outcome Measures
Name Time Method To evaluate the clinical efficacy of Lactoferrin cream + Luliconazole cream in resolving cutaneous candidiasis & dermatophytosis, as measured by clinical symptom improvement & mycological cure rates. <br/ ><br>To assess the safety & tolerability of Lactoferrin cream + Luliconazole cream compared to Luliconazole cream alone in patients with cutaneous candidiasis & dermatophytosis.Timepoint: Day 14