A single centre, prospective, multiple arms, randomised, open label, 7-day study to assess under dermatological control, the in-use skin compatibility and cosmetic acceptability of a range of four Dettol bar soaps for use on the face
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- To assess the in use cutaneous compatibility of each of the four test formulations when used on the face for 7 days
研究概览
简要总结
A singlecenter, prospective, multiple arms, randomised, open-label, 7-day study toassess under dermatological control, the in-use skin compatibility and cosmeticacceptability of a range of four Dettol bar soaps for use on the face. Thestudy will be performed on behalf of RB by Cliantha. The dermatologistappointed by Cliantha will assess skin type and other subject selectioncriteria for each subject recruited to the study.
The testsite for this study will be the full face. Dermatologist cutaneous assessmentof the test site test will be visually assessed for irritation at 30 minutespost initial use and following 7 days in use as per the irritancy grading scale.
The study isdesigned to evaluate if the test products will cause a drying effect withrepeated use and if this effect will cause irritation on facial skin.
SPQs havebeen included to provide a subjective assessment of the test product tolerance(i.e. feeling of dryness / tightness / smoothness).
Subjectswill use the product to cleanse their face at least once daily. The testproducts should not be used more than twice daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject able to give written informed consent and from whom written informed consent has been obtained.
- •Healthy male and female subjects between the ages of 18 and 55 years inclusive at the time of informal consent.
- •Subject with Fitzpatrick Scale Phototype III to V skin 4) Subjects who are able to understand the study, co-operate with the study procedures and prohibitions, and are able to attend all study assessments.
排除标准
- •Female subject who is pregnant (self-report), lactating, have given birth within the previous 3 months or are planning to become pregnant in the duration of the study.
- •Female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent.
- •Subject with known skin disorders (acne, psoriasis, eczema, rosacea, or other).
- •Subjects with dry or sensitive skin on the face (interrogation of skin type by questionnaire and dermatologist assessment).
- •Subject with known allergies to any of the test product ingredients.
- •Subject with excessive hair growth on the face that in opinion if the Investigator will hinder visual assessment of the test site.
- •Subjects with freckles, beauty spots, birthmarks, or a tattoo at the test site.
- •Subject with a history of type 1 or type 2 diabetes.
- •Subject with peripheral vascular disease or poor blood circulation (self-reported).
- •Subject with a significant past medical history of the hepatic, renal, cardiac, pulmonary, digestive, haematological, endocrinological, neurological, locomotor, or psychiatric disease which, in the opinion of the investigator, would compromise the safety of the subject.
- •Subject with a history of skin tumours or malignant disease.
- •Subject whose skin has been excessively exposed to the sun or to UV rays during the previous month in the opinion of the Investigator.
- •Subject who is suffering from chronic asthma, a malfunction of the lymphatic system, or an autoimmune deficiency disease (e.g. lupus, thyroiditis).
- •Subject taking antihistamine or steroid preparations, any medication for the treatment of diabetes mellitus, immunosuppressive drugs, or any other medication which, in the opinion of the investigator, may affect the test results.
- •Subject who has a history of excessive drug or alcohol use (in line with national guidance) which will affect the test results in the opinion of the Investigator.
- •Subject with any conditions, which in the opinion of the investigator, may affect the results of the study.
- •Subject who has participated in any clinical study during the previous month or are currently participating in a separate clinical study.
- •Employee at the study site.
- •Any partner or first-degree relative of the subject who has a role in the study at the vendor site.
- •Subject unable in the opinion of the Investigator to comply fully with the study requirements.
结局指标
主要结局
To assess the in use cutaneous compatibility of each of the four test formulations when used on the face for 7 days
时间窗: An assessment of the Mean Irritation Index (M.I.I.) at 30 mins post initial use and after 7 days in-use.
次要结局
- 1. Subject self-assessment of tolerance on Days 1-7 with use of SPQs.(2. Dermatologist Global assessment of tolerance at Day 7 for each Subject.)