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

Johnson & Johnson Consumer Inc. (J&JCI)46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Skin Skin Care Skin Cream

Interventions

Moisturizer A, F#9155-005DRUG

OTC Monograph Drug. Used twice daily on left or right lower leg per randomization schedule.

Moisturizer B, F#E1387-004OTHER

Cosmetic Moisturizer. Used twice daily on left or right lower leg per randomization schedule.

RegressionPROCEDURE

2 week regression period after 6 weeks of moisturizer use.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Thomas J. Stephens & Associates, Inc.

Colorado Springs, Colorado, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to Week 6

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Physical insult (tape stripping) on the lower leg after 6 weeks of moisturizer use.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to Week 2

Mean Change from Baseline to Week 4 in Clinical Tolerance Grading

Time frame: Baseline to Week 4

Mean Change from Baseline to Week 6 in Clinical Tolerance Grading

Time frame: Baseline to Week 6

Mean Change from Regression Baseline to Regression Day 1 in Clinical Tolerance Grading

Time frame: Regression Baseline to Regression Day 1

Mean Change from Regression Baseline to Regression Day 4 in Clinical Tolerance Grading

Time frame: Regression Baseline to Regression Day 4

Mean Change from Regression Baseline to Regression Day 7 in Clinical Tolerance Grading

Time frame: Regression Baseline to Regression Day 7

Mean Change from Regression Baseline to Regression Day 10 in Clinical Tolerance Grading

Time frame: Regression Baseline to Regression Day 10

Mean Change from Regression Baseline to Regression Day 14 in Clinical Tolerance Grading

Time frame: 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.

Time frame: Baseline to Week 4

Mean Change from Baseline to Week 6 in TEWL

Time frame: Baseline to Week 6

Mean Change from Regression Baseline to Regression Day 1 in TEWL

Time frame: Regression Baseline to Regression Day 1

Mean Change from Regression Baseline to Regression Day 4 in TEWL

Time frame: Regression Baseline to Regression Day 4

Mean Change from Regression Baseline to Regression Day 7 in TEWL

Time frame: Regression Baseline to Regression Day 7

Mean Change from Regression Baseline to Regression Day 10 in TEWL

Time frame: Regression Baseline to Regression Day 10

Mean Change from Regression Baseline to Regression Day 14 in TEWL

Time frame: 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.

Time frame: Baseline to Week 4

Mean Change from Baseline to Week 6 in Skin Hydration

Time frame: Baseline to Week 6

Mean Change from Regression Baseline to Regression Day 1 in Skin Hydration

Time frame: Regression Baseline to Regression Day 1

Mean Change from Regression Baseline to Regression Day 4 in Skin Hydration

Time frame: Regression Baseline to Regression Day 4

Mean Change from Regression Baseline to Regression Day 7 in Skin Hydration

Time frame: Regression Baseline to Regression Day 7

Mean Change from Regression Baseline to Regression Day 10 in Skin Hydration

Time frame: Regression Baseline to Regression Day 10

Mean Change from Regression Baseline to Regression Day 14 in Skin Hydration

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to Week 4

Mean Change from Baseline to Week 6 in NMFs using D-Squames

Time frame: 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.

Time frame: 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.

Time frame: Baseline to Week 6