NCT03093181已完成不适用
A Randomized, Parallel-group, Evaluator-blind, No-treatment and Positive Controlled, Single-site, Proof of Concept Clinical Study to Evaluate the Cosmetic Benefit Provided by 8 Weeks of Twice-daily Topical Application of a Developmental Moisturizing Cream With Niacinamide in Healthy Subjects With Sensitive, Oily, Blemish-prone Skin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Change From Baseline in Corneometer Values at 8 Hours on Day 1
研究概览
简要总结
This study is designed to evaluate the cosmetic benefit provided by twice daily application of a developmental moisturising cream with niacinamide for 8 weeks in healthy female participants with sensitive, oily, blemish-prone skin.
详细描述
This study broadly consists of two phases: screening / washout phase (5-7 day) followed by treatment phase (approximately of 8 weeks). Participants will be asked to return to the study site 1 week, 4 weeks and 8 weeks after their randomisation visit for instrumental measurements and clinical assessments.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- •Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination
- •Willingness to actively participate in the study and to attend all scheduled visits
- •Minimum of 10 and maximum of 25 blemishes (papules and pustules) at Visit 1 and a minimum of 8 blemishes (papules and pustules) at Visit 2
- •Fitzpatrick photo-type I-V
- •Sebumeter score of >66 µg / cm2 at the forehead
- •Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) OR male partner sterilization prior to the female participant's entry into the study, and this male is the sole partner for that participant
- •Cleanses their face at least once a day
排除标准
- •Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- •Women who are breast-feeding
- •Medical history of using a medicated acne treatment (e.g. Benzoyl Peroxide, Clindamycin, isotretinoin) within the last 12 months
- •Change in contraception within the last 3 months
- •Active skin disease in the test area
- •Medical history of dysplastic nevi or melanoma on the face
- •Moles, cysts, tattoos, scars, irritated skin, hairs, etc. at the test area that could influence the investigation
- •Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines within 7 days prior to the start of the study and/or throughout the entire course of the study
- •Systemic use of anti-microbials within the last month
- •Systemic use of over-the-counter (OTC) analgesics or anti-inflammatory drugs 24 hours prior to dosing at the first assessment visit
- •One of the following illnesses that might require regular systemic medication: Insulin-dependent diabetes, cancer
- •One of the following illnesses if not medicated: Asthma, hypertension
- •Medical history of abnormal response to sunlight
- •History of mental illness
- •Medically diagnosed acne vulgaris, acne conglobate, fulminans, secondary acne (drug induced acne) or any acne requiring systemic or topical treatment
- •No aesthetic, cosmetic or dermatological treatment in the treatment area (face) within the last month
- •No intense sun exposure, Ultraviolet-treatments or tanning salon visit within the last 2 weeks
- •Known or suspected intolerance, allergy or hypersensitivity to study materials (or closely related compounds) or any of their stated ingredients
- •History of allergies to cosmetic products or medicated acne treatments
- •Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
- •Previous participation in this study
- •Recent history (within the last 5 years) of alcohol or other substance abuse
- •An employee of the sponsor or the study site or members of their immediate family
结局指标
主要结局
Change From Baseline in Corneometer Values at 8 Hours on Day 1
时间窗: At Baseline and Day 1
A blinded, trained and qualified evaluator conducted instrumental measurements of skin moisturization.Measurement of skin moisturization was performed by the electrical capacitance method with a Corneometer CM 865. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content.The range of hydration level was 0 (as dry as possible)\~120 AU (Arbitrary Unit)(most moist possible).Higher Corneometer values are indicative of improved skin moisturization.
次要结局
- Odds for Logistic Regression Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline(At Baseline and Week 8)
- ANOVA Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline(At Baseline and Week 8)
- Change From Baseline in Corneometer Values at 1 and 3 Hours on Day 1 and at Week 1, 4 and 8(At Baseline, Day 1, Week 1, 4 and 8)
- Change From Baseline in Sebum Excretion Rate at Week 1, 4 and 8(At Baseline, Week 1, 4 and 8)
- Change From Baseline in Evaluator's Assessment of Total Blemish Count at Week 1, 4, and 8(At Baseline, Week 1, 4 and 8)
- Change From Baseline in Sebumeter Values at Week 1, 4 and 8(At Baseline, Week 1, 4 and 8)
研究者
研究点 (2)
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