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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regression Group | Other | 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). |
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| Non-Regression Group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moisturizer A, F#9155-005 | Drug | OTC Monograph Drug. Used twice daily on left or right lower leg per randomization schedule. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline to Week 6 in Clinical Grading of Skin Dryness | 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. | Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline to Week 2 in Clinical Grading of Skin Dryness | 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. | Baseline to Week 2 |
| Mean Change from Baseline to Week 4 in Clinical Grading of Skin Dryness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neena Tierney | Johnson & Johnson Consumer Inc. (J&JCI) | Study Director |
| Kun "Mark" Qian, M.D. | Thomas J. Stephens & Associates, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas J. Stephens & Associates, Inc. | Colorado Springs | Colorado | 80915 | United States |
Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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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.
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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.
| Moisturizer B, F#E1387-004 | Other | Cosmetic Moisturizer. Used twice daily on left or right lower leg per randomization schedule. |
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| Regression | Procedure | 2 week regression period after 6 weeks of moisturizer use. |
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| Non-Regression | Procedure | Physical insult (tape stripping) on the lower leg after 6 weeks of moisturizer use. |
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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. |
| Baseline to Week 4 |
| Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Dryness | 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. | Regression Baseline to Regression Day 1 |
| Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Dryness | 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. | Regression Baseline to Regression Day 4 |
| Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Dryness | 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. | Regression Baseline to Regression Day 7 |
| Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Skin Dryness | 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. | Regression Baseline to Regression Day 10 |
| Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Skin Dryness | 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. | Regression Baseline to Regression Day 14 |
| Mean Change from Baseline to Week 2 in Clinical Grading of Skin Cracking | The investigator assessed each of the subject's lower legs for skin cracking on a scale of 0 (none) to 8 (obvious cracking). Whole points only. | Baseline to Week 2 |
| Mean Change from Baseline to Week 4 in Clinical Grading of Skin Cracking | The investigator assessed each of the subject's lower legs for skin cracking on a scale of 0 (none) to 8 (obvious cracking). Whole points only. | Baseline to Week 4 |
| Mean Change from Baseline to Week 6 in Clinical Grading of Skin Cracking | The investigator assessed each of the subject's lower legs for skin cracking on a scale of 0 (none) to 8 (obvious cracking). Whole points only. | Baseline to Week 6 |
| Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Cracking | The investigator assessed each of the subject's lower legs for skin cracking on a scale of 0 (none) to 8 (obvious cracking). Whole points only. | Regression Baseline to Regression Day 1 |
| Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Cracking | The investigator assessed each of the subject's lower legs for skin cracking on a scale of 0 (none) to 8 (obvious cracking). Whole points only. | Regression Baseline to Regression Day 4 |
| Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Cracking | The investigator assessed each of the subject's lower legs for skin cracking on a scale of 0 (none) to 8 (obvious cracking). Whole points only. | Regression Baseline to Regression Day 7 |
| Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Skin Cracking | The investigator assessed each of the subject's lower legs for skin cracking on a scale of 0 (none) to 8 (obvious cracking). Whole points only. | Regression Baseline to Regression Day 10 |
| Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Skin Cracking | The investigator assessed each of the subject's lower legs for skin cracking on a scale of 0 (none) to 8 (obvious cracking). Whole points only. | Regression Baseline to Regression Day 14 |
| Mean Change from Baseline to Week 2 in Clinical Grading of Skin Scaling | The investigator assessed each of the subject's lower legs for skin scaling on a scale of 0 (none) to 8 (large scales). Whole points only. | Baseline to Week 2 |
| Mean Change from Baseline to Week 4 in Clinical Grading of Skin Scaling | The investigator assessed each of the subject's lower legs for skin scaling on a scale of 0 (none) to 8 (large scales). Whole points only. | Baseline to Week 4 |
| Mean Change from Baseline to Week 6 in Clinical Grading of Skin Scaling | The investigator assessed each of the subject's lower legs for skin scaling on a scale of 0 (none) to 8 (large scales). Whole points only. | Baseline to Week 6 |
| Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Scaling | The investigator assessed each of the subject's lower legs for skin scaling on a scale of 0 (none) to 8 (large scales). Whole points only. | Regression Baseline to Regression Day 1 |
| Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Scaling | The investigator assessed each of the subject's lower legs for skin scaling on a scale of 0 (none) to 8 (large scales). Whole points only. | Regression Baseline to Regression Day 4 |
| Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Scaling | The investigator assessed each of the subject's lower legs for skin scaling on a scale of 0 (none) to 8 (large scales). Whole points only. | Regression Baseline to Regression Day 7 |
| Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Skin Scaling | The investigator assessed each of the subject's lower legs for skin scaling on a scale of 0 (none) to 8 (large scales). Whole points only. | Regression Baseline to Regression Day 10 |
| Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Skin Scaling | The investigator assessed each of the subject's lower legs for skin scaling on a scale of 0 (none) to 8 (large scales). Whole points only. | Regression Baseline to Regression Day 14 |
| Mean Change from Baseline to Week 2 in Clinical Grading of Tactile Roughness | The investigator assessed each of the subject's lower legs for tactile roughness on a scale of 0 (none) to 3 (severe) scale. Half-points allowed. | Baseline to Week 2 |
| Mean Change from Baseline to Week 4 in Clinical Grading of Tactile Roughness | The investigator assessed each of the subject's lower legs for tactile roughness on a scale of 0 (none) to 3 (severe) scale. Half-points allowed. | Baseline to Week 4 |
| Mean Change from Baseline to Week 6 in Clinical Grading of Tactile Roughness | The investigator assessed each of the subject's lower legs for tactile roughness on a scale of 0 (none) to 3 (severe) scale. Half-points allowed. | Baseline to Week 6 |
| Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Tactile Roughness | The investigator assessed each of the subject's lower legs for tactile roughness on a scale of 0 (none) to 3 (severe) scale. Half-points allowed. | Regression Baseline to Regression Day 1 |
| Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Tactile Roughness | The investigator assessed each of the subject's lower legs for tactile roughness on a scale of 0 (none) to 3 (severe) scale. Half-points allowed. | Regression Baseline to Regression Day 4 |
| Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Tactile Roughness | The investigator assessed each of the subject's lower legs for tactile roughness on a scale of 0 (none) to 3 (severe) scale. Half-points allowed. | Regression Baseline to Regression Day 7 |
| Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Tactile Roughness | The investigator assessed each of the subject's lower legs for tactile roughness on a scale of 0 (none) to 3 (severe) scale. Half-points allowed. | Regression Baseline to Regression Day 10 |
| Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Tactile Roughness | The investigator assessed each of the subject's lower legs for tactile roughness on a scale of 0 (none) to 3 (severe) scale. Half-points allowed. | Regression Baseline to Regression Day 14 |
| Mean Change from Baseline to Week 2 in Clinical Tolerance Grading | The investigator assessed each of the subject's lower legs for the following tolerance parameters on a scale of 0 (none) to 3 (severe):
| Baseline to Week 2 |
| Mean Change from Baseline to Week 4 in Clinical Tolerance Grading | The investigator assessed each of the subject's lower legs for the following tolerance parameters on a scale of 0 (none) to 3 (severe):
| Baseline to Week 4 |
| Mean Change from Baseline to Week 6 in Clinical Tolerance Grading | The investigator assessed each of the subject's lower legs for the following tolerance parameters on a scale of 0 (none) to 3 (severe):
| Baseline to Week 6 |
| Mean Change from Regression Baseline to Regression Day 1 in Clinical Tolerance Grading | The investigator assessed each of the subject's lower legs for the following tolerance parameters on a scale of 0 (none) to 3 (severe):
| Regression Baseline to Regression Day 1 |
| Mean Change from Regression Baseline to Regression Day 4 in Clinical Tolerance Grading | The investigator assessed each of the subject's lower legs for the following tolerance parameters on a scale of 0 (none) to 3 (severe):
| Regression Baseline to Regression Day 4 |
| Mean Change from Regression Baseline to Regression Day 7 in Clinical Tolerance Grading | The investigator assessed each of the subject's lower legs for the following tolerance parameters on a scale of 0 (none) to 3 (severe):
| Regression Baseline to Regression Day 7 |
| Mean Change from Regression Baseline to Regression Day 10 in Clinical Tolerance Grading | The investigator assessed each of the subject's lower legs for the following tolerance parameters on a scale of 0 (none) to 3 (severe):
| Regression Baseline to Regression Day 10 |
| Mean Change from Regression Baseline to Regression Day 14 in Clinical Tolerance Grading | The investigator assessed each of the subject's lower legs for the following tolerance parameters on a scale of 0 (none) to 3 (severe):
| Regression Baseline to Regression Day 14 |
| Mean Change from Baseline to Week 4 in TEWL | Transepidermal water loss (TEWL), a measure of the passive transfer of water through the outer layer of the skin in g/m2/h, was measured with an open-chambered evaporimeter. Three measurements were taken per leg. | Baseline to Week 4 |
| Mean Change from Baseline to Week 6 in TEWL | Transepidermal water loss (TEWL), a measure of the passive transfer of water through the outer layer of the skin in g/m2/h, was measured with an open-chambered evaporimeter. Three measurements were taken per leg. | Baseline to Week 6 |
| Mean Change from Regression Baseline to Regression Day 1 in TEWL | Transepidermal water loss (TEWL), a measure of the passive transfer of water through the outer layer of the skin in g/m2/h, was measured with an open-chambered evaporimeter. Three measurements were taken per leg. | Regression Baseline to Regression Day 1 |
| Mean Change from Regression Baseline to Regression Day 4 in TEWL | Transepidermal water loss (TEWL), a measure of the passive transfer of water through the outer layer of the skin in g/m2/h, was measured with an open-chambered evaporimeter. Three measurements were taken per leg. | Regression Baseline to Regression Day 4 |
| Mean Change from Regression Baseline to Regression Day 7 in TEWL | Transepidermal water loss (TEWL), a measure of the passive transfer of water through the outer layer of the skin in g/m2/h, was measured with an open-chambered evaporimeter. Three measurements were taken per leg. | Regression Baseline to Regression Day 7 |
| Mean Change from Regression Baseline to Regression Day 10 in TEWL | Transepidermal water loss (TEWL), a measure of the passive transfer of water through the outer layer of the skin in g/m2/h, was measured with an open-chambered evaporimeter. Three measurements were taken per leg. | Regression Baseline to Regression Day 10 |
| Mean Change from Regression Baseline to Regression Day 14 in TEWL | Transepidermal water loss (TEWL), a measure of the passive transfer of water through the outer layer of the skin in g/m2/h, was measured with an open-chambered evaporimeter. Three measurements were taken per leg. | Regression Baseline to Regression Day 14 |
| Mean Change from Baseline to Week 4 in Skin Hydration | Skin hydration of the lower legs was measured with two different instruments: 1) a Corneometer, which measures hydration in arbitrary units from 0 to 120, with higher values indicating more hydrated skin, and 2) Skicon, which measures hydration in microSiemens (uS) from 0 to 2000, with higher values indicating more hydrated skin. Five measurements were taken with each instrument. | Baseline to Week 4 |
| Mean Change from Baseline to Week 6 in Skin Hydration | Skin hydration of the lower legs was measured with two different instruments: 1) a Corneometer, which measures hydration in arbitrary units from 0 to 120, with higher values indicating more hydrated skin, and 2) Skicon, which measures hydration in microSiemens (uS) from 0 to 2000, with higher values indicating more hydrated skin. Five measurements were taken with each instrument. | Baseline to Week 6 |
| Mean Change from Regression Baseline to Regression Day 1 in Skin Hydration | Skin hydration of the lower legs was measured with two different instruments: 1) a Corneometer, which measures hydration in arbitrary units from 0 to 120, with higher values indicating more hydrated skin, and 2) Skicon, which measures hydration in microSiemens (uS) from 0 to 2000, with higher values indicating more hydrated skin. Five measurements were taken with each instrument. | Regression Baseline to Regression Day 1 |
| Mean Change from Regression Baseline to Regression Day 4 in Skin Hydration | Skin hydration of the lower legs was measured with two different instruments: 1) a Corneometer, which measures hydration in arbitrary units from 0 to 120, with higher values indicating more hydrated skin, and 2) Skicon, which measures hydration in microSiemens (uS) from 0 to 2000, with higher values indicating more hydrated skin. Five measurements were taken with each instrument. | Regression Baseline to Regression Day 4 |
| Mean Change from Regression Baseline to Regression Day 7 in Skin Hydration | Skin hydration of the lower legs was measured with two different instruments: 1) a Corneometer, which measures hydration in arbitrary units from 0 to 120, with higher values indicating more hydrated skin, and 2) Skicon, which measures hydration in microSiemens (uS) from 0 to 2000, with higher values indicating more hydrated skin. Five measurements were taken with each instrument. | Regression Baseline to Regression Day 7 |
| Mean Change from Regression Baseline to Regression Day 10 in Skin Hydration | Skin hydration of the lower legs was measured with two different instruments: 1) a Corneometer, which measures hydration in arbitrary units from 0 to 120, with higher values indicating more hydrated skin, and 2) Skicon, which measures hydration in microSiemens (uS) from 0 to 2000, with higher values indicating more hydrated skin. Five measurements were taken with each instrument. | Regression Baseline to Regression Day 10 |
| Mean Change from Regression Baseline to Regression Day 14 in Skin Hydration | Skin hydration of the lower legs was measured with two different instruments: 1) a Corneometer, which measures hydration in arbitrary units from 0 to 120, with higher values indicating more hydrated skin, and 2) Skicon, which measures hydration in microSiemens (uS) from 0 to 2000, with higher values indicating more hydrated skin. Five measurements were taken with each instrument. | Regression Baseline to Regression Day 14 |
| Mean Change from Baseline to Week 4 in Skin Flaking using D-Squames | D-Squame tapes were used to collect skin surface cells. The first tape was placed on a D-Squame storage card. Image analysis was used to calculate the degree of skin flaking. | Baseline to Week 4 |
| Mean Change from Baseline to Week 6 in Skin Flaking using D-Squames | D-Squame tapes were used to collect skin surface cells. The first tape was placed on a D-Squame storage card. Image analysis was used to calculate the degree of skin flaking. | Baseline to Week 6 |
| Mean Change from Baseline to Week 4 in NMFs using D-Squames | D-Squame tapes were used to collect skin surface cells. The second tape was stored in a scintillation vial and shipped to a designated lab for analysis of natural moisturizing factors (NMFs), components of the skin that help it maintain adequate hydration. | Baseline to Week 4 |
| Mean Change from Baseline to Week 6 in NMFs using D-Squames | D-Squame tapes were used to collect skin surface cells. The second tape was stored in a scintillation vial and shipped to a designated lab for analysis of natural moisturizing factors (NMFs), components of the skin that help it maintain adequate hydration. | Baseline to Week 6 |
| Mean Change from Baseline to Week 4 in Epidermal Lipids | Special adhesive tapes were used to collect and analyze epidermal lipid samples from the skin surface. | Baseline to Week 4 |
| Mean Change from Baseline to Week 6 in Epidermal Lipids | Special adhesive tapes were used to collect and analyze epidermal lipid samples from the skin surface. | Baseline to Week 6 |