A Controlled Clinical Study of 2 Different Moisturizers for the Relief of Dry Skin

Study Overview
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Brief Summary
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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.

Official Title
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A Bilateral, Controlled Clinical Trial to Evaluate 2 Different Moisturizer Chassis Formulas for the Relief of Dry Skin

Conditions
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Skin, Skin Care, Skin Cream

Intervention / Treatment
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* Drug: Moisturizer A, F#9155-005
* Other: Moisturizer B, F#E1387-004
* Procedure: Regression
* Procedure: Non-Regression


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Regression Group<br>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). | Drug: Moisturizer A, F#9155-005<br>* OTC Monograph Drug. Used twice daily on left or right lower leg per randomization schedule.<br>Other: Moisturizer B, F#E1387-004<br>* Cosmetic Moisturizer. Used twice daily on left or right lower leg per randomization schedule.<br>Procedure: Regression<br>* 2 week regression period after 6 weeks of moisturizer use.<br>|
| Other: Non-Regression Group<br>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. | Drug: Moisturizer A, F#9155-005<br>* OTC Monograph Drug. Used twice daily on left or right lower leg per randomization schedule.<br>Other: Moisturizer B, F#E1387-004<br>* Cosmetic Moisturizer. Used twice daily on left or right lower leg per randomization schedule.<br>Procedure: Non-Regression<br>* Physical insult (tape stripping) on the lower leg after 6 weeks of moisturizer use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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): erythema edema burning/stinging (via subject interview) itching (via subject interview) tightness (via subject interview) Half-points allowed. | 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): erythema edema burning/stinging (via subject interview) itching (via subject interview) tightness (via subject interview) Half-points allowed. | 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): erythema edema burning/stinging (via subject interview) itching (via subject interview) tightness (via subject interview) Half-points allowed. | 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): erythema edema burning/stinging (via subject interview) itching (via subject interview) tightness (via subject interview) Half-points allowed. | 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): erythema edema burning/stinging (via subject interview) itching (via subject interview) tightness (via subject interview) Half-points allowed. | 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): erythema edema burning/stinging (via subject interview) itching (via subject interview) tightness (via subject interview) Half-points allowed. | 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): erythema edema burning/stinging (via subject interview) itching (via subject interview) tightness (via subject interview) Half-points allowed. | 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): erythema edema burning/stinging (via subject interview) itching (via subject interview) tightness (via subject interview) Half-points allowed. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin, Stratum Corneum, Skin Care, Skin Cream, Dryness, Moisturization, Hydration