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
试验速览
- 阶段
- 2 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- PRO - 5-D itch scale
研究概览
简要总结
To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Confirmed SD diagnosis by dermatologist
- •Significant facial SD affected area as judged by the investigator or medically qualified designee
- •Able to participate and willing to give written informed consent and to comply with the study restrictions;
- •Willing to refrain from using other SD treatments in the local treatment area
- •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.
排除标准
- •Any current and / or recurrent clinical significant skin condition other than SD;
- •Ongoing use of prohibited SD medication. Washout periods prior to baseline are as follows;
- •Topical steroids, antibiotics, antifungals or other topical (OTC) therapies: 2 weeks
- •Systemic steroids, antibiotics, antifungals or other systemic therapies: 4 weeks;
- •Phototherapy: 3 weeks;
- •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
- •Changing a soap, method for daily facial and hair washing: 1 week
- •Known hypersensitivity to the compounds or excipients of the compounds;
- •Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment;
- •Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
- •Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year;
- •Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
研究组 & 干预措施
Omiganan Topical Gel
Omiganan 1.75%
干预措施: Omiganan (Drug)
Ketoconazole Topical Cream
Ketoconazole 2.0%
干预措施: Ketoconazole (Drug)
Vehicle
干预措施: Placebo (Drug)
结局指标
主要结局
PRO - 5-D itch scale
时间窗: 6 Weeks
Multidimensional measure of itching. Covers 5 domains: duration, degree, direction, disability and distribution.
Sebum measurements
时间窗: 6 Weeks
Measurement of sebum excretion by Sebumeter
Seborrheic dermatitis area severity index (SDASI)
时间窗: 6 Weeks
Assessment of erythema, scales and papules and each are scored as 0=none to 3=severe.
PRO - dermatology life quality index (DLQI)
时间窗: 6 Weeks
Asses health-related quality of life in general dermatology disability index
Investigator global assessment (IGA)
时间窗: 6 Weeks
This is a 5-point scale ranging from 0=clear to 4=severe.
Area of involvement
时间窗: 6 Weeks
Facial area involvement is estimated as a % of the body surface area (BSA)
Liquid chromatography-mass spectrometry (LC-MS)
时间窗: 6 Weeks
Will evaluate the changes in lipid composition of stratum corneum (SC).
Patient Reported Outcome (PRO) - eDiary
时间窗: 4 Weeks
Single-question assessment regarding patient's worst itch. On a scale of 0-100, 0=no itch and 100=worst itch.
Standardized photography
时间窗: 6 Weeks
Facial photographs will be taken by a 2D camera (VISIA-CR)
Trans Epidermal Water Loss (TEWL)
时间窗: 6 Weeks
To assess barrier status of lesional and non-lesional skin.
Optical Coherence Tomography (OCT)
时间窗: 6 Weeks
Measurement of cutaneous morphology of seborrheic dermatitis
次要结局
- Chemistry blood sample assessment(6 Weeks)
- Skin microbiota(6 Weeks)
- 12-Lead ECGs performed at screening and end of study(6 Weeks)
- Haematology blood sample assessment(6 Weeks)
- Skin mycobiota(6 Weeks)
- Faecal microbiome(4 Weeks)
- Adverse events collected throughout the study(6 Weeks)
- Urinalysis urine sample assessment(6 Weeks)
- Collection of concomitant medications(6 Weeks)
- Vital signs performed at screening and end of study(6 Weeks)