A Single Center, Randomized, Open-Label, Prospective, Parallel Group Study to Evaluate antifungal and biofilm inhibition activity of formulation containing Lactoferrin cream + Luliconazole cream against Luliconazole Cream in the Treatment of Patients with cutaneous Candidiasis and Dermatophytosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
This study is “A Single Center, Randomized, Open-Label, Prospective, Parallel Group Study to Evaluate antifungal and biofilm inhibition activity of formulation containing Lactoferrin cream + Luliconazole cream against Luliconazole Cream in the Treatment of Patients with cutaneous Candidiasis and Dermatophytosisâ€.†The study will be conducted at a single center in India by a qualified Investigator, in dermatologist. The study will be initiated only after receipt of regulatory and EC.approval.
| Title |
"A Single Center, Randomized, Open-Label, Prospective, Parallel Group Study to Evaluate antifungal and biofilm inhibition activity of formulation containing Lactoferrin cream + Luliconazole cream against Luliconazole Cream in the Treatment of Patients with cutaneous Candidiasis and Dermatophytosisâ€"
Short Title
To Evaluate antifungal and biofilm inhibition activity of formulation containing Lactoferrin cream + Luliconazole cream against Luliconazole Cream in the Treatment of Patients with Cutaneous Candidiasis and Dermatophytosis
Protocol Number: Lf-Af/2023/01
Phase: Pilot phase
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •Candidial onychomycosis Dermatophytosis includes A.
- •Tinea barbae B.
- •Tinea capitis C.
- •Tinea corporis D.
- •Tinea cruris E.
- •Tinea pedis
- •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
- •Patients agree not to use Æ’any 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.
- •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.
- •Patients with the ability to understand and provide a written informed consent form before the screening.
- •Patients willing to comply with the protocol requirements throughout the study.
排除标准
- •Patients are excluded from the study if any of the following criteria apply
- •Patients with known or suspected hypersensitivity to quinolone antibacterial agents or azoles for example Ketoconazole.
- •Patients with the presence of any skin condition that would interfere with the diagnosis or assessment of cutaneous candidiasis.
- •Patients receiving treatment with the following products a.
- •Systemic antifungals for the treatment of cutaneous candidiasis in the 30 days before the baseline visit.
- •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.
- •Patients with uncontrolled hypertension with sitting systolic BP 160 mmHg and or diastolic BP100 mmHg at screening.
- •Females who are pregnant or lactating or planning to become pregnant during the study period.
- •Patients with a history of experiencing significant burning or stinging when applying any topical treatment.
- •Patients with a serious and or chronic medical conditions.
- •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.
- •Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days before signing informed consent.
结局指标
主要结局
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.
时间窗: Day 14
次要结局
- To evaluate the clinical efficacy of Lactoferrin cream + Luliconazole cream in resolving cutaneous candidiasis & dermatophytosis, as measured by clinical symptom improvement & mycological cure rates.(To assess the safety & tolerability of Lactoferrin cream + Luliconazole cream compared to Luliconazole cream alone in patients with cutaneous candidiasis & dermatophytosis.)
研究者
Dr Dhruv R Patel
Namostute Hospital