Clinical trial NCT04510103: A Controlled Clinical Study of 2 Different Moisturizers for the Relief of Dry Skin
Official title: A Bilateral, Controlled Clinical Trial to Evaluate 2 Different Moisturizer Chassis Formulas for the Relief of Dry Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin
Skin Care
Skin Cream
Keywords: Skin
Stratum Corneum
Skin Care
Skin Cream
Dryness
Moisturization
Hydration
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2020-08-12
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects were assigned to one of two procedural groups (Regression or Non-Regression) based on Visit 1 scheduling. Subjects were provided with a commercial cleanser to use during a 3-day period with no moisturizers and no hair removal allowed on their lower legs, and to continue using throughout the study. At Visit 2, all subjects received the two test moisturizers to use split-leg (right vs. left lower leg randomized) to use for 6 weeks. Subjects returned for evaluations at Week 2 (Visit 3), Week 4 (Visit 4), and Week 6 (Visit 5). At Week 6, subjects in the Regression group entered a 2-week regression period (no moisturizer usage) and returned for evaluations at Regression Days 1, 4, 7, 10, and 14. Meanwhile, at Week 6, subjects in the Non-Regression group (exploratory) continued using the moisturizers; they returned for evaluations at Week 6 + Days 1, 2, 3, and 4.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Change from Baseline to Week 6 in Clinical Grading of Skin Dryness
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Mean Change from Baseline to Week 2 in Clinical Grading of Skin Dryness
timeFrame: Baseline to Week 2
measure: Mean Change from Baseline to Week 4 in Clinical Grading of Skin Dryness
timeFrame: Baseline to Week 4
measure: Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Dryness
timeFrame: Regression Baseline to Regression Day 1
measure: Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Dryness
timeFrame: Regression Baseline to Regression Day 4
measure: Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Dryness
timeFrame: Regression Baseline to Regression Day 7
measure: Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Skin Dryness
timeFrame: Regression Baseline to Regression Day 10
measure: Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Skin Dryness
timeFrame: Regression Baseline to Regression Day 14
measure: Mean Change from Baseline to Week 2 in Clinical Grading of Skin Cracking
timeFrame: Baseline to Week 2
measure: Mean Change from Baseline to Week 4 in Clinical Grading of Skin Cracking
timeFrame: Baseline to Week 4
measure: Mean Change from Baseline to Week 6 in Clinical Grading of Skin Cracking
timeFrame: Baseline to Week 6
measure: Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Cracking
timeFrame: Regression Baseline to Regression Day 1
measure: Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Cracking
timeFrame: Regression Baseline to Regression Day 4
measure: Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Cracking
timeFrame: Regression Baseline to Regression Day 7
measure: Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Skin Cracking
timeFrame: Regression Baseline to Regression Day 10
measure: Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Skin Cracking
timeFrame: Regression Baseline to Regression Day 14
measure: Mean Change from Baseline to Week 2 in Clinical Grading of Skin Scaling
timeFrame: Baseline to Week 2
measure: Mean Change from Baseline to Week 4 in Clinical Grading of Skin Scaling
timeFrame: Baseline to Week 4
measure: Mean Change from Baseline to Week 6 in Clinical Grading of Skin Scaling
timeFrame: Baseline to Week 6
measure: Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Scaling
timeFrame: Regression Baseline to Regression Day 1
measure: Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Scaling
timeFrame: Regression Baseline to Regression Day 4
measure: Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Scaling
timeFrame: Regression Baseline to Regression Day 7
measure: Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Skin Scaling
timeFrame: Regression Baseline to Regression Day 10
measure: Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Skin Scaling
timeFrame: Regression Baseline to Regression Day 14
measure: Mean Change from Baseline to Week 2 in Clinical Grading of Tactile Roughness
timeFrame: Baseline to Week 2
measure: Mean Change from Baseline to Week 4 in Clinical Grading of Tactile Roughness
timeFrame: Baseline to Week 4
measure: Mean Change from Baseline to Week 6 in Clinical Grading of Tactile Roughness
timeFrame: Baseline to Week 6
measure: Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Tactile Roughness
timeFrame: Regression Baseline to Regression Day 1
measure: Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Tactile Roughness
timeFrame: Regression Baseline to Regression Day 4
measure: Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Tactile Roughness
timeFrame: Regression Baseline to Regression Day 7
measure: Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Tactile Roughness
timeFrame: Regression Baseline to Regression Day 10
measure: Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Tactile Roughness
timeFrame: Regression Baseline to Regression Day 14
measure: Mean Change from Baseline to Week 2 in Clinical Tolerance Grading
timeFrame: Baseline to Week 2
measure: Mean Change from Baseline to Week 4 in Clinical Tolerance Grading
timeFrame: Baseline to Week 4
measure: Mean Change from Baseline to Week 6 in Clinical Tolerance Grading
timeFrame: Baseline to Week 6
measure: Mean Change from Regression Baseline to Regression Day 1 in Clinical Tolerance Grading
timeFrame: Regression Baseline to Regression Day 1
measure: Mean Change from Regression Baseline to Regression Day 4 in Clinical Tolerance Grading
timeFrame: Regression Baseline to Regression Day 4
measure: Mean Change from Regression Baseline to Regression Day 7 in Clinical Tolerance Grading
timeFrame: Regression Baseline to Regression Day 7
measure: Mean Change from Regression Baseline to Regression Day 10 in Clinical Tolerance Grading
timeFrame: Regression Baseline to Regression Day 10
measure: Mean Change from Regression Baseline to Regression Day 14 in Clinical Tolerance Grading
timeFrame: Regression Baseline to Regression Day 14
measure: Mean Change from Baseline to Week 4 in TEWL
timeFrame: Baseline to Week 4
measure: Mean Change from Baseline to Week 6 in TEWL
timeFrame: Baseline to Week 6
measure: Mean Change from Regression Baseline to Regression Day 1 in TEWL
timeFrame: Regression Baseline to Regression Day 1
measure: Mean Change from Regression Baseline to Regression Day 4 in TEWL
timeFrame: Regression Baseline to Regression Day 4
measure: Mean Change from Regression Baseline to Regression Day 7 in TEWL
timeFrame: Regression Baseline to Regression Day 7
measure: Mean Change from Regression Baseline to Regression Day 10 in TEWL
timeFrame: Regression Baseline to Regression Day 10
measure: Mean Change from Regression Baseline to Regression Day 14 in TEWL
timeFrame: Regression Baseline to Regression Day 14
measure: Mean Change from Baseline to Week 4 in Skin Hydration
timeFrame: Baseline to Week 4
measure: Mean Change from Baseline to Week 6 in Skin Hydration
timeFrame: Baseline to Week 6
measure: Mean Change from Regression Baseline to Regression Day 1 in Skin Hydration
timeFrame: Regression Baseline to Regression Day 1
measure: Mean Change from Regression Baseline to Regression Day 4 in Skin Hydration
timeFrame: Regression Baseline to Regression Day 4
measure: Mean Change from Regression Baseline to Regression Day 7 in Skin Hydration
timeFrame: Regression Baseline to Regression Day 7
measure: Mean Change from Regression Baseline to Regression Day 10 in Skin Hydration
timeFrame: Regression Baseline to Regression Day 10
measure: Mean Change from Regression Baseline to Regression Day 14 in Skin Hydration
timeFrame: Regression Baseline to Regression Day 14
measure: Mean Change from Baseline to Week 4 in Skin Flaking using D-Squames
timeFrame: Baseline to Week 4
measure: Mean Change from Baseline to Week 6 in Skin Flaking using D-Squames
timeFrame: Baseline to Week 6
measure: Mean Change from Baseline to Week 4 in NMFs using D-Squames
timeFrame: Baseline to Week 4
measure: Mean Change from Baseline to Week 6 in NMFs using D-Squames
timeFrame: Baseline to Week 6
measure: Mean Change from Baseline to Week 4 in Epidermal Lipids
timeFrame: Baseline to Week 4
measure: Mean Change from Baseline to Week 6 in Epidermal Lipids
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Thomas J. Stephens & Associates, Inc.
state: Colorado
Study officials:
affiliation: Johnson & Johnson Consumer Inc. (J&JCI)
name: Neena Tierney
role: STUDY_DIRECTOR
affiliation: Thomas J. Stephens & Associates, Inc.
name: Kun "Mark" Qian, M.D.
role: PRINCIPAL_INVESTIGATOR
References: