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

Not Applicable

Completed

• Conditions: Skin Care; Skin Cream; Skin
• Interventions: Drug: Moisturizer A, F#9155-005; Other: Moisturizer B, F#E1387-004; Procedure: Non-Regression; Procedure: Regression

• Registration Number: NCT04510103
• Lead Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-23
• Primary Completion: 2016-03-25
• Study Completion: 2016-04-07
• Status Verified: 2020-08
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Last Update Submitted: 2020-08-10
• Study First Posted: 2020-08-12
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regression Group	Moisturizer A, F#9155-005	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).
Regression Group	Moisturizer B, F#E1387-004	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).
Non-Regression Group	Moisturizer A, F#9155-005	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.
Non-Regression Group	Non-Regression	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.
Regression Group	Regression	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).
Non-Regression Group	Moisturizer B, F#E1387-004	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.

Primary Outcome Measures

Name	Time	Method
Mean Change from Baseline to Week 6 in Clinical Grading of Skin Dryness	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 Outcome Measures

Name	Time	Method
Mean Change from Baseline to Week 6 in Clinical Grading of Skin Cracking	Baseline to Week 6	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.
Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Cracking	Regression Baseline to Regression Day 1	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.
Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Skin Dryness	Regression Baseline to Regression Day 10	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.
Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Dryness	Regression Baseline to Regression Day 1	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.
Mean Change from Baseline to Week 4 in Clinical Grading of Skin Scaling	Baseline to Week 4	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.
Mean Change from Baseline to Week 4 in Clinical Grading of Skin Dryness	Baseline to Week 4	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.
Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Dryness	Regression Baseline to Regression Day 4	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.
Mean Change from Baseline to Week 2 in Clinical Grading of Skin Cracking	Baseline to Week 2	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.
Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Cracking	Regression Baseline to Regression Day 4	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.
Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Skin Cracking	Regression Baseline to Regression Day 14	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.
Mean Change from Baseline to Week 2 in Clinical Grading of Skin Scaling	Baseline to Week 2	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.
Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Scaling	Regression Baseline to Regression Day 4	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.
Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Skin Scaling	Regression Baseline to Regression Day 14	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.
Mean Change from Baseline to Week 2 in Clinical Grading of Skin Dryness	Baseline to Week 2	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.
Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Dryness	Regression Baseline to Regression Day 7	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.
Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Skin Dryness	Regression Baseline to Regression Day 14	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.
Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Skin Cracking	Regression Baseline to Regression Day 10	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.
Mean Change from Baseline to Week 4 in Clinical Grading of Tactile Roughness	Baseline to Week 4	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.
Mean Change from Baseline to Week 4 in Clinical Tolerance Grading	Baseline to Week 4	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.
Mean Change from Baseline to Week 4 in TEWL	Baseline to Week 4	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.
Mean Change from Regression Baseline to Regression Day 4 in Skin Hydration	Regression Baseline to Regression Day 4	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.
Mean Change from Baseline to Week 4 in Clinical Grading of Skin Cracking	Baseline to Week 4	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.
Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Cracking	Regression Baseline to Regression Day 7	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.
Mean Change from Baseline to Week 6 in Clinical Grading of Skin Scaling	Baseline to Week 6	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.
Mean Change from Baseline to Week 2 in Clinical Grading of Tactile Roughness	Baseline to Week 2	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.
Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Tactile Roughness	Regression Baseline to Regression Day 14	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.
Mean Change from Baseline to Week 6 in Clinical Tolerance Grading	Baseline to Week 6	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.
Mean Change from Regression Baseline to Regression Day 1 in Clinical Tolerance Grading	Regression Baseline to Regression Day 1	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.
Mean Change from Regression Baseline to Regression Day 7 in Clinical Tolerance Grading	Regression Baseline to Regression Day 7	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.
Mean Change from Regression Baseline to Regression Day 14 in TEWL	Regression Baseline to Regression Day 14	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.
Mean Change from Baseline to Week 4 in NMFs using D-Squames	Baseline to Week 4	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.
Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Scaling	Regression Baseline to Regression Day 1	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.
Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Tactile Roughness	Regression Baseline to Regression Day 10	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.
Mean Change from Regression Baseline to Regression Day 10 in Clinical Tolerance Grading	Regression Baseline to Regression Day 10	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.
Mean Change from Regression Baseline to Regression Day 4 in TEWL	Regression Baseline to Regression Day 4	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.
Mean Change from Regression Baseline to Regression Day 1 in Skin Hydration	Regression Baseline to Regression Day 1	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.
Mean Change from Baseline to Week 6 in Skin Flaking using D-Squames	Baseline to Week 6	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.
Mean Change from Baseline to Week 6 in NMFs using D-Squames	Baseline to Week 6	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.
Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Scaling	Regression Baseline to Regression Day 7	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.
Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Skin Scaling	Regression Baseline to Regression Day 10	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.
Mean Change from Baseline to Week 6 in Clinical Grading of Tactile Roughness	Baseline to Week 6	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.
Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Tactile Roughness	Regression Baseline to Regression Day 1	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.
Mean Change from Baseline to Week 2 in Clinical Tolerance Grading	Baseline to Week 2	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.
Mean Change from Regression Baseline to Regression Day 4 in Clinical Tolerance Grading	Regression Baseline to Regression Day 4	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.
Mean Change from Regression Baseline to Regression Day 14 in Clinical Tolerance Grading	Regression Baseline to Regression Day 14	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.
Mean Change from Baseline to Week 6 in TEWL	Baseline to Week 6	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.
Mean Change from Regression Baseline to Regression Day 10 in TEWL	Regression Baseline to Regression Day 10	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.
Mean Change from Regression Baseline to Regression Day 14 in Skin Hydration	Regression Baseline to Regression Day 14	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.
Mean Change from Baseline to Week 4 in Epidermal Lipids	Baseline to Week 4	Special adhesive tapes were used to collect and analyze epidermal lipid samples from the skin surface.
Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Tactile Roughness	Regression Baseline to Regression Day 4	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.
Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Tactile Roughness	Regression Baseline to Regression Day 7	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.
Mean Change from Regression Baseline to Regression Day 1 in TEWL	Regression Baseline to Regression Day 1	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.
Mean Change from Regression Baseline to Regression Day 7 in TEWL	Regression Baseline to Regression Day 7	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.
Mean Change from Baseline to Week 4 in Skin Hydration	Baseline to Week 4	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.
Mean Change from Baseline to Week 6 in Skin Hydration	Baseline to Week 6	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.
Mean Change from Baseline to Week 6 in Epidermal Lipids	Baseline to Week 6	Special adhesive tapes were used to collect and analyze epidermal lipid samples from the skin surface.
Mean Change from Regression Baseline to Regression Day 7 in Skin Hydration	Regression Baseline to Regression Day 7	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.
Mean Change from Regression Baseline to Regression Day 10 in Skin Hydration	Regression Baseline to Regression Day 10	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.
Mean Change from Baseline to Week 4 in Skin Flaking using D-Squames	Baseline to Week 4	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.

Trial Locations

Locations (1)

Thomas J. Stephens & Associates, Inc.; 🇺🇸 Colorado Springs, Colorado, United States