The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis: a Phase 2, Randomized, Double-blind Study
This will be an interventional safety and efficacy study of CELENT07 when used as a topical treatment of onychomycosis in the toenails (tinea unguium) of adults 18 years and older. This is randomized, double-blind, parallel design, placebo and active controlled study in patients with mild to moderate toenail distal lateral subungual onychomycosis (DLSO) (n=120). Subjects will be randomized (1:1:1) to receive CELENXT07, placebo of CELENXT07 or PENLAC®, daily for 52 weeks. Efficacy assessments will include complete cure, mycologic cure and clinical efficacy and safety and tolerability.
A Phase 3 Double Blind, Randomized, Placebo Controlled, Cross-Over Trial to Asses the Efficacy of CALPXT96™in Improving Sleep Quality in Patients With Chronic Non-cancer Pain
California Poppy has been traditionally used in Herbal Medicine as an analgesic, mild sedative and/or sleep aid. However there are no human clinical trial data to support its use. Sleep disturbances are a well-recognized component of chronic pain, and lead to additional social withdrawal, greater pain and worsening depression. Most hypnotics available either place the patient at further risk (e.g. benzodiazepines combined with opioids increase the risk of central or obstructive sleep apnea), increase adverse events (dry mouth, daytime somnolence, etc.) or induce sleep but do not improve the quality of sleep (no increase in Rapid Eye Movement or curative sleep). This study intends to use California Poppy to avoid adverse effects while improving sleep. An open-label clinical trial was performed to obtain preliminary safety and efficacy information of California poppy. This trial was approved by a central ethics review board. The study results showed that California poppy, can be used as a co-analgesic to provide additional analgesia and/or sleep improvement to the patient. Patients who are referred to the clinic will be asked to complete a few short questionnaires at every visit and on monthly basis respectively. This data, in addition to the usual follow-up questionnaires used by the clinics' physicians (McGill Pain Intensity, Pain Disability Index, Short-form Health Survey-12v2) and general demographic and medical information will be used to assess California Poppy's effectiveness on patients
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