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

Skin Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510103
• Other study ID #: PS-150914160029-SACT
• Status: Completed
• Phase: N/A
• Start date: October 23, 2015
• Est. completion date: April 7, 2016

Study information

• Verified date: August 2020
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 7, 2016
• Est. primary completion date: March 25, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin
• Skin Care
• Skin Cream

Intervention

Drug:
• Moisturizer A, F#9155-005
OTC Monograph Drug. Used twice daily on left or right lower leg per randomization schedule.

Other:
• Moisturizer B, F#E1387-004
Cosmetic Moisturizer. Used twice daily on left or right lower leg per randomization schedule.

Procedure:
• Regression
2 week regression period after 6 weeks of moisturizer use.
• Non-Regression
Physical insult (tape stripping) on the lower leg after 6 weeks of moisturizer use.

Locations

Country	Name	City	State
United States	Thomas J. Stephens & Associates, Inc.	Colorado Springs	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer Inc. (J&JCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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