ACTRN12619001734156已完成1 期
An Open-Label Study to Evaluate the Safety and Efficacy of Topical Hidracare Solution in Participants with Mild to Moderate Hidradenitis Suppurativa (as defined by Hurley Stage I or II) Over an 8-Week Treatment Period.
Aerotech Australia Pty Ltd0 个研究点目标入组 19 人开始时间: 2019年12月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Males and females 18 years or older.
- •2.Diagnosis by dermatologist of hidradenitis suppurativa, as defined by Hurley Stage I or II.
- •3.A minimum of one lesion in at least one distinct anatomical location.
- •4.Participant must read and understand the informed consent form, and must have signed it prior to any study-related procedures being performed.
- •5.Willingness and ability to comply with all scheduled study visits and study procedures.
排除标准
- •1.The use of any HS treatment (excluding study product) during the study and during the 4 weeks prior to study entry. Participants may remain on other medications provided they have been on a stable dose for at least 4 weeks prior to study entry and that the dose remains stable throughout the study.
- •2.Participants are not to use any topical products on the HS area/s, such as washes, deodorant or make-up during the study or during the 2 weeks prior to screening/baseline visit.
- •3.Participant does not agree to refrain from draining fluid from the affected HS area/s for the duration of the study.
- •4.Women who are pregnant or lactating. All women of childbearing potential must complete a urine pregnancy test at Screening (Visit 1) and the result must be negative to be eligible for enrolment.
- •5.Female participants of childbearing potential who are sexually active and are not willing to use a highly effective method of contraception. Female participants should refrain from getting pregnant for the duration of the study.
- •6.Any participant who does not agree to apply the product to the affected HS area/s twice daily for the duration of the treatment period.
- •7.Participants who have any disease or condition that is likely to interfere with the evaluation of the study product, such as skin cancers or any other co-morbidity deemed by the investigator to be not suitable for this study.
- •8.Participant has a known allergy to any of the ingredients used in Hidracare.
- •9.Participation in any investigational study within 8 weeks of screening visit.
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