A Clinical Study to Evaluate the Cumulative Irritation Patch Test of Jolune MBG-179 and MBG-180 on Healthy Human volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This is a single-center, evaluator-blinded, randomized, intra-individual controlled study.
Each subject will serve as their own control. Three test sites will be delineated on the upper back (scapular region) of each subject.
The location of the three test materials , positive control, negative control) will be randomized for each subject. A new set of patches will then be applied to the exact same sites. This procedure will be repeated for 14 days 3 times a week.
Study Duration: The total study participation for each subject will be approximately 16 days. This includes a Screening Visit, a 14-day treatment period (Day 1 to Day 14), and a Final Follow-up Visit.
Guideline Followed: IS10993 PART 23
30 healthy male and female volunteers aged 18 to 65 years
Test Product :
-
MBG-179
-
MBG-180
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female, between 18 and 65 years of age, inclusive.
- •In good general health as determined by medical history and physical examination.
- •Willing and able to provide written informed consent prior to any study-related procedures.
- •Willing and able to comply with all study procedures and visit schedules.
- •Skin on the upper back must be free of acne, sunburn, scars, tattoos, moles, or any other condition that could interfere with patch application or skin evaluation.
- •Females of childbearing potential (FOCP) must have a negative urine pregnancy test at screening and agree to use a medically acceptable method of contraception throughout the study.
排除标准
- •History of or active dermatological condition (e.g., eczema, psoriasis, dermatitis) on the back or that could be exacerbated by the study.
- •Known allergy or sensitivity to cosmetics, topical drugs, medical adhesives (tapes), or any of the test material components, including SLS.
- •Use of systemic or topical corticosteroids, retinoids, or immunosuppressants within 4 weeks prior to Day
- •Application of any topical product (including moisturizers) to the back within 24 hours prior to Day
- •Excessive sun exposure or use of tanning beds on the back within 2 weeks prior to Day
- •Currently pregnant, planning to become pregnant, or breastfeeding.
- •Participation in any other clinical trial involving an investigational drug or device within 30 days prior to Day
- •Any condition which, in the opinion of the Principal Investigator, would place the subject at undue risk or interfere with the interpretation of the study results.
研究者
Dr Robin Chugh
CCFT Laboratories