A Bilateral, Controlled Clinical Trial to Evaluate 2 Different Moisturizer Chassis Formulas for the Relief of Dry Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Mean Change from Baseline to Week 6 in Clinical Grading of Skin Dryness
研究概览
简要总结
Dry skin is characterized by a lack of moisture in the outer layer of the skin and can occur as a result of numerous factors including cold weather, low humidity, age, etc. In this study, the moisturizing benefits of two formulas were evaluated for barrier function improvement/impact when used by women with moderately to severely dry skin on their lower legs.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The test moisturizers were assigned a product code; each moisturizer was assigned to a subject's right or left lower leg per a randomization schedule. Subjects were blinded to the product identities, and evaluators were blinded to which product was used on each leg. Procedural group was unblinded and based on scheduling at Visit 1.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •moderately to severely dry skin on both leg legs, as determined by the investigator.
- •Fitzpatrick skin types I-IV
- •generally in good health
- •routinely uses moisturizers on the legs at least 1-3 times per week.
- •if of reproductive potential: using a medically acceptable form of birth control for at least 3 months before the study and willing to continue it for at least 1 month after study completion.
- •able to read, write, speak, and understand English.
- •willing and able to complete all study instructions.
- •has completed the informed consent document including a HIPAA disclosure and photograph release.
排除标准
- •known allergies/sensitivities to adhesive tapes or study product ingredients.
- •known skin conditions, uncontrolled medical conditions, or any other condition that could interfere with evaluations/data interpretation or increase risk to the subject.
- •any active bacterial/fungal/viral skin infections or susceptibility to such infections.
- •females who are pregnant, breastfeeding, or planning to become pregnant in near future.
- •compromised/broken skin, tattoos, scarring, excessive hair growth, very uneven skin tone, or other conditions that would interfere with evaluations or increase risk to the subject.
- •current participation in another study.
- •participation in another study in past 4 weeks.
- •employees or relatives of the investigator or study site.
研究组 & 干预措施
Regression Group
The Regression Group received the two test moisturizers to use split-leg (right vs. left lower leg randomized) for 6 weeks and then entered a 2-week regression period (no moisturizer usage).
干预措施: Moisturizer A, F#9155-005 (Drug)
Regression Group
The Regression Group received the two test moisturizers to use split-leg (right vs. left lower leg randomized) for 6 weeks and then entered a 2-week regression period (no moisturizer usage).
干预措施: Moisturizer B, F#E1387-004 (Other)
Regression Group
The Regression Group received the two test moisturizers to use split-leg (right vs. left lower leg randomized) for 6 weeks and then entered a 2-week regression period (no moisturizer usage).
干预措施: Regression (Procedure)
Non-Regression Group
The Non-Regression Group received the two test moisturizers to use split-leg (right vs. left lower leg randomized) for 6 weeks and then underwent a physical insult (tape stripping) on the lower legs and continued using the moisturizer for 4 additional days.
干预措施: Moisturizer A, F#9155-005 (Drug)
Non-Regression Group
The Non-Regression Group received the two test moisturizers to use split-leg (right vs. left lower leg randomized) for 6 weeks and then underwent a physical insult (tape stripping) on the lower legs and continued using the moisturizer for 4 additional days.
干预措施: Moisturizer B, F#E1387-004 (Other)
Non-Regression Group
The Non-Regression Group received the two test moisturizers to use split-leg (right vs. left lower leg randomized) for 6 weeks and then underwent a physical insult (tape stripping) on the lower legs and continued using the moisturizer for 4 additional days.
干预措施: Non-Regression (Procedure)
结局指标
主要结局
Mean Change from Baseline to Week 6 in Clinical Grading of Skin Dryness
时间窗: Baseline to Week 6
The investigator assessed each of the subject's lower legs for skin dryness on a scale of 0 (no dryness) to 4 (severe scaling/fissuring). Half-points allowed.
次要结局
- Mean Change from Baseline to Week 6 in Clinical Grading of Skin Cracking(Baseline to Week 6)
- Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Cracking(Regression Baseline to Regression Day 1)
- Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Skin Dryness(Regression Baseline to Regression Day 10)
- Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Dryness(Regression Baseline to Regression Day 1)
- Mean Change from Baseline to Week 4 in Clinical Grading of Skin Scaling(Baseline to Week 4)
- Mean Change from Baseline to Week 4 in Clinical Grading of Skin Dryness(Baseline to Week 4)
- Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Dryness(Regression Baseline to Regression Day 4)
- Mean Change from Baseline to Week 2 in Clinical Grading of Skin Cracking(Baseline to Week 2)
- Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Cracking(Regression Baseline to Regression Day 4)
- Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Skin Cracking(Regression Baseline to Regression Day 14)
- Mean Change from Baseline to Week 2 in Clinical Grading of Skin Scaling(Baseline to Week 2)
- Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Scaling(Regression Baseline to Regression Day 4)
- Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Skin Scaling(Regression Baseline to Regression Day 14)
- Mean Change from Baseline to Week 2 in Clinical Grading of Skin Dryness(Baseline to Week 2)
- Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Dryness(Regression Baseline to Regression Day 7)
- Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Skin Dryness(Regression Baseline to Regression Day 14)
- Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Skin Cracking(Regression Baseline to Regression Day 10)
- Mean Change from Baseline to Week 4 in Clinical Grading of Tactile Roughness(Baseline to Week 4)
- Mean Change from Baseline to Week 4 in Clinical Tolerance Grading(Baseline to Week 4)
- Mean Change from Baseline to Week 4 in TEWL(Baseline to Week 4)
- Mean Change from Regression Baseline to Regression Day 4 in Skin Hydration(Regression Baseline to Regression Day 4)
- Mean Change from Baseline to Week 4 in Clinical Grading of Skin Cracking(Baseline to Week 4)
- Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Cracking(Regression Baseline to Regression Day 7)
- Mean Change from Baseline to Week 6 in Clinical Grading of Skin Scaling(Baseline to Week 6)
- Mean Change from Baseline to Week 2 in Clinical Grading of Tactile Roughness(Baseline to Week 2)
- Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Tactile Roughness(Regression Baseline to Regression Day 14)
- Mean Change from Baseline to Week 6 in Clinical Tolerance Grading(Baseline to Week 6)
- Mean Change from Regression Baseline to Regression Day 1 in Clinical Tolerance Grading(Regression Baseline to Regression Day 1)
- Mean Change from Regression Baseline to Regression Day 7 in Clinical Tolerance Grading(Regression Baseline to Regression Day 7)
- Mean Change from Regression Baseline to Regression Day 14 in TEWL(Regression Baseline to Regression Day 14)
- Mean Change from Baseline to Week 4 in NMFs using D-Squames(Baseline to Week 4)
- Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Scaling(Regression Baseline to Regression Day 1)
- Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Tactile Roughness(Regression Baseline to Regression Day 10)
- Mean Change from Regression Baseline to Regression Day 10 in Clinical Tolerance Grading(Regression Baseline to Regression Day 10)
- Mean Change from Regression Baseline to Regression Day 4 in TEWL(Regression Baseline to Regression Day 4)
- Mean Change from Regression Baseline to Regression Day 1 in Skin Hydration(Regression Baseline to Regression Day 1)
- Mean Change from Baseline to Week 6 in Skin Flaking using D-Squames(Baseline to Week 6)
- Mean Change from Baseline to Week 6 in NMFs using D-Squames(Baseline to Week 6)
- Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Scaling(Regression Baseline to Regression Day 7)
- Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Skin Scaling(Regression Baseline to Regression Day 10)
- Mean Change from Baseline to Week 6 in Clinical Grading of Tactile Roughness(Baseline to Week 6)
- Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Tactile Roughness(Regression Baseline to Regression Day 1)
- Mean Change from Baseline to Week 2 in Clinical Tolerance Grading(Baseline to Week 2)
- Mean Change from Regression Baseline to Regression Day 4 in Clinical Tolerance Grading(Regression Baseline to Regression Day 4)
- Mean Change from Regression Baseline to Regression Day 14 in Clinical Tolerance Grading(Regression Baseline to Regression Day 14)
- Mean Change from Baseline to Week 6 in TEWL(Baseline to Week 6)
- Mean Change from Regression Baseline to Regression Day 10 in TEWL(Regression Baseline to Regression Day 10)
- Mean Change from Regression Baseline to Regression Day 14 in Skin Hydration(Regression Baseline to Regression Day 14)
- Mean Change from Baseline to Week 4 in Epidermal Lipids(Baseline to Week 4)
- Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Tactile Roughness(Regression Baseline to Regression Day 4)
- Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Tactile Roughness(Regression Baseline to Regression Day 7)
- Mean Change from Regression Baseline to Regression Day 1 in TEWL(Regression Baseline to Regression Day 1)
- Mean Change from Regression Baseline to Regression Day 7 in TEWL(Regression Baseline to Regression Day 7)
- Mean Change from Baseline to Week 4 in Skin Hydration(Baseline to Week 4)
- Mean Change from Baseline to Week 6 in Skin Hydration(Baseline to Week 6)
- Mean Change from Baseline to Week 6 in Epidermal Lipids(Baseline to Week 6)
- Mean Change from Regression Baseline to Regression Day 7 in Skin Hydration(Regression Baseline to Regression Day 7)
- Mean Change from Regression Baseline to Regression Day 10 in Skin Hydration(Regression Baseline to Regression Day 10)
- Mean Change from Baseline to Week 4 in Skin Flaking using D-Squames(Baseline to Week 4)