A Randomized, Double-Blind, Active- and Vehicle-Controlled Study to Compare the Efficacy and Safety of Products S2G6T-1, S2G6T-2, S2G6T-3 and S2G6T-4 in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 283
- 试验地点
- 19
- 主要终点
- Complete cure at Day 29
研究概览
简要总结
To assess the efficacy and safety of a combination product S2G6T-1 compared to its monads and vehicle, applied twice daily for 7 days, in the treatment of symptomatic inflammatory interdigital tinea pedis in subjects 12 years of age and older. The results of this study will be utilized to perform power calculations for the Phase 3 pivotal trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and willingness to sign a written informed consent and /or assent (age appropriate).
- •Male or Female subjects 12 years of age or older.
- •A clinical diagnosis of interdigital tinea pedis on one or both feet characterized by clinical evidence of a tinea infection.
- •A sum of at least five (5) for signs (erythema and scaling) by the investigator on the selected target foot, and a score of at least five (5) for each symptom: pruritus (itching) and burning: and a sum of at least twelve (12) for both symptoms (pruritus and burning) by the subject on the PATSS.
- •Mycological evidence of the presence of fungi confirmed by the detection of fungal hyphae on a microscopic KOH wet mount.
- •Females of child-bearing potential must have a negative urine pregnancy test and must agree to use an effective form of contraception during the study .
- •Must be in good general health as determined by medical history and free of any disease that in the investigator's opinion might interfere with the study evaluations.
- •Must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements.
排除标准
- •The presence of confluent diffuse moccasin-type tinea pedis.
- •Negative KOH microscopy test to assess presence of hyphae.
- •Onychomycosis of the toenails, involving ≥ 20% of the area of either great toenail or involvement of more than five toenails in total.
- •Concurrent tinea infection or bacterial skin infection on the feet.
- •Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
- •Recent history of or currently known to abuse drugs or alcohol.
- •History of intolerance or hypersensitivity to Econazole Nitrate, Mometasone Furoate, or other imidazole agents.
- •Presence of any other infection of the foot or other disease process that might confound the treatment evaluation.
- •Having a life-threatening condition or immunocompromised (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
- •Unable to communicate or cooperate with the investigator due to language barriers, poor mental development, or impaired cerebral function.
- •Current participation in a clinical drug research study or recent participation in a clinical trial within 30 days of Baseline.
- •Using the following medications prior to Baseline:
- •Antipruritics, including antihistamines within 3 days (72 hours).
- •Topical corticosteroids, antibiotics or antifungal therapies within 4 weeks.
- •Systemic corticosteroids, antibiotics or antifungal therapies within 12 weeks.
- •Oral terbinafine or itraconazole within 12 weeks.
- •Immunosuppressive medication or radiation therapy within 12 weeks.
- •Any other topical medicated topical treatments to the treatment area(s) within 7 days.
研究组 & 干预措施
S2G6T-1
Topical cream
干预措施: S2G6T-1 (Drug)
S2G6T-2
Topical Cream
干预措施: S2G6T-2 (Drug)
S2G6T-3
Topical Cream
干预措施: S2G6T-3 (Drug)
S2G6T-4
Topical Cream
干预措施: S2G6T-4 (Drug)
结局指标
主要结局
Complete cure at Day 29
时间窗: Day 29
The primary efficacy comparison between S2G6T-1 vs. rest of study arms will be based on the percentage of subjects at day 29 with complete cure of interdigital tinea pedis.mycological cure (i.e. negative dermatophyte culture and negative KOH) and clinical cure (i.e. absence of erythema, scaling and pruritus {scores of 0, each})
Reduction in Tinea pedis SymptomS through treatment period.
时间窗: Day 8
comparison of Patient Assessment between S2G6T-1 vs. rest of study arms will be based on the percentage of subjects at day 8 with achieving decrease from baseline in the total score for pruritus and burning.
次要结局
未报告次要终点