NCT04510103
Completed
Not Applicable
A Bilateral, Controlled Clinical Trial to Evaluate 2 Different Moisturizer Chassis Formulas for the Relief of Dry Skin
Johnson & Johnson Consumer Inc. (J&JCI)1 site in 1 country46 target enrollmentOctober 23, 2015
Overview
- Phase
- Not Applicable
- Intervention
- Moisturizer A, F#9155-005
- Conditions
- Skin
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Mean Change from Baseline to Week 6 in Clinical Grading of Skin Dryness
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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).
Intervention: Moisturizer A, F#9155-005
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).
Intervention: Moisturizer B, F#E1387-004
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).
Intervention: Regression
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.
Intervention: Moisturizer A, F#9155-005
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.
Intervention: Moisturizer B, F#E1387-004
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.
Intervention: Non-Regression
Outcomes
Primary Outcomes
Mean Change from Baseline to Week 6 in Clinical Grading of Skin Dryness
Time Frame: 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.
Secondary Outcomes
- 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)
Study Sites (1)
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