Clinical Evaluation of Day and Night Skin Care Creams Supplemented With MediCell Technology (MCT)'s Composition of Defensins and Supportive Molecules
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for superficial wrinkles
研究概览
简要总结
This is a placebo-controlled blinded clinical evaluation of day and night skin care creams supplemented by Medicell Technology's composition of defensins and supportive molecules determine the skin hydration and anti-aging properties of the topical test articles after repeated application to the skin of human subjects.
详细描述
45 participants will be selected to participate in a placebo-controlled blinded trial comparing the use of the Full Formulas versus the Null Formulas (2 groups). 15 participants will be enrolled at each study site.
Each participant will test the Test System simultaneously as instructed: The Mask one-to-two times a week plus the Cream and the Serum twice daily (morning and evening); the detailed Directions are shown in Exhibit 2. The test System will be applied directly on face, postauricular and neck skin.
All study subjects will also be provided with Skinfo Clean But Not Dry cleanser and EltaMD UV Pure Broad Spectrum Sun Protective Factor (SPF) 47. Subjects will be instructed to wash their face twice daily with the cleanser and apply the sunscreen each morning after application of the Test System.
Both the study subjects and their physicians will be blinded in terms of the treatment group (the Full Formula or the Null Formula).
Subjects will be screening, consented and enrolled according to Good Clinical Practice.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sex: Female
- •Fitzpatrick Skin Types: I-VI
- •Age: 40 - 75 years
- •Individuals who will be able to read, understand and give an informed consent relation to the study they are participating in.
- •Individuals who will be free of any dermatological or systemic disorder, which in the Principal Investigator's opinion, could interfere with the study results.
- •Individuals who will be in general good health and who will complete a preliminary medical history form mandated by the clinic.
- •Individuals who will be able to and agree to cooperate with the Investigator and research staff.
- •Individuals who will agree to have test products applied in accordance with the protocol and are able to complete the full course of the study.
- •Individuals who will agree to have 2 biopsies on the postauricular area if randomly selected.
- •Individuals who will agree to not participate in any other study during the entire length of the study and have not participated in a similar study in the past 30 days.
排除标准
- •Individuals who are currently taking any medications (topical or systemic) that may mask or interfere with the test results.
- •Individuals who have a history of any acute or chronic disease that might interfere with or increase the risk on study participation. (e.g., systemic lupus erythematosus, rheumatoid arthritis, HIV positive).
- •Individuals who are diagnosed with chronic skin allergies (atopic dermatitis/eczema) or recently treated skin cancer within the last 12 months.
- •Individuals who control their diabetes using insulin.
- •Individuals with any history, which in the Investigator's opinion, indicates the potential for harm to the subject or places the validity of the study in jeopardy.
- •Individuals who indicate that they are pregnant or are planning to become pregnant or nursing.
- •Individuals who have undergone any of the following procedures:
- •Botox within 6 months before enrollment into study and until study completion
- •Injectable filler within 3 months before enrollment into study and until study completion
- •Lasers or tissue tightening devices (ultherapy, radiofrequency, skin tightening, microcurrent or photorejuvenation, photodynamic therapy) within 6 months before enrollment into study and until study completion
- •Sculptra or Bellafill prior to enrollment into the study and until study completion
研究组 & 干预措施
Group 1 Sham
Null Formula of the Test System
干预措施: Null Formula 2-Minute Reveal Masque (Drug)
Group 1 Sham
Null Formula of the Test System
干预措施: Null Formula 24/7 Barrier Repair Cream (Drug)
Group 1 Sham
Null Formula of the Test System
干预措施: Null Formula 8-in-1 BioSerum (Drug)
Group 2 Treated
Full Formulas of Test System
干预措施: 2-Minute Reveal Masque (Drug)
Group 2 Treated
Full Formulas of Test System
干预措施: 24/7 Barrier Repair Cream (Drug)
Group 2 Treated
Full Formulas of Test System
干预措施: 8-in-1 BioSerum (Drug)
结局指标
主要结局
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for superficial wrinkles
时间窗: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for skin turgor
时间窗: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for pore size
时间窗: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for deep wrinkles
时间窗: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for skin radiancy
时间窗: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for erythema
时间窗: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for scaling and dryness
时间窗: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for hyperpigmentation
时间窗: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for edema
时间窗: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for hypopigmentation
时间窗: Baseline and 12 weeks
次要结局
未报告次要终点