A phase 2, randomized, vehicle and ketoconazole-controlled, evaluator-blinded, study to explore the efficacy, pharmacodynamics and safety of omiganan 1.75% topical gel BID in patients with mild to moderate facial seborrheic dermatitis.

Maruho Co., Ltd.0 个研究点目标入组 36 人开始时间: 2018年8月2日最近更新: 2021年4月5日

试验速览

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•For enrollment of subjects the following criteria must be met:
•1.Male and female subjects with mild to moderate facial SD (IGA 2 or 3), =18 years of age, inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than SD following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
•2.Confirmed SD diagnosis by dermatologist
•3.Significant facial SD affected area as judged by the investigator or medically qualified designee.
•4.Able to participate and willing to give written informed consent and to comply with the study restrictions;
•5.Willing to refrain from using other SD treatments in the local treatment area
•6.Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 36
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 36

•Eligible subjects must meet none of the following exclusion criteria:
•1.Any current and / or recurrent clinical significant skin condition other than SD;
•2.Ongoing use of prohibited SD medication. Washout periods prior to baseline are as follows;
•a.Topical steroids, antibiotics, antifungals or other topical (OTC) therapies: 2 weeks
•b.Systemic steroids, antibiotics, antifungals or other systemic therapies: 4 weeks;
•c.Phototherapy: 3 weeks;
•d.Regular use of shampoo for the treatment of PC (including but not limited to OTC zinc pyrithione shampoo), soap for the treatment of seborrheic dermatitis: 2 weeks
•e.Changing a soap, method for daily facial and hair washing: 1 week
•3.Known hypersensitivity to the compounds or excipients of the compounds;
•4.Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment;
•5.Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
•6.Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year;
•7.Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.

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