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Completed

NCT Number: NCT04510103

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

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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Key information

Conditions

Skin Skin Care Skin Cream

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Thomas J. Stephens & Associates, Inc.

Colorado Springs, Colorado, 80915, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moisturizer A, F#9155-005

Drug

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

Moisturizer B, F#E1387-004

Other

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

Regression

Procedure

2 week regression period after 6 weeks of moisturizer use.

Non-Regression

Procedure

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

Primary outcomes

  1. Mean Change from Baseline to Week 6 in Clinical Grading of Skin Dryness

    Time frame: 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 outcomes

  1. Mean Change from Baseline to Week 2 in Clinical Grading of Skin Dryness

    Time frame: 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.

  2. Mean Change from Baseline to Week 4 in Clinical Grading of Skin Dryness

    Time frame: 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.

  3. Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Dryness

    Time frame: 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.

  4. Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Dryness

    Time frame: 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.

  5. Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Dryness

    Time frame: 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.

  6. Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Skin Dryness

    Time frame: 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.

  7. Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Skin Dryness

    Time frame: 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.

  8. Mean Change from Baseline to Week 2 in Clinical Grading of Skin Cracking

    Time frame: 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.

  9. Mean Change from Baseline to Week 4 in Clinical Grading of Skin Cracking

    Time frame: 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.

  10. Mean Change from Baseline to Week 6 in Clinical Grading of Skin Cracking

    Time frame: 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.

  11. Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Cracking

    Time frame: 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.

  12. Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Cracking

    Time frame: 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.

  13. Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Cracking

    Time frame: 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.

  14. Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Skin Cracking

    Time frame: 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.

  15. Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Skin Cracking

    Time frame: 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.

  16. Mean Change from Baseline to Week 2 in Clinical Grading of Skin Scaling

    Time frame: 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.

  17. Mean Change from Baseline to Week 4 in Clinical Grading of Skin Scaling

    Time frame: 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.

  18. Mean Change from Baseline to Week 6 in Clinical Grading of Skin Scaling

    Time frame: 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.

  19. Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Scaling

    Time frame: 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.

  20. Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Scaling

    Time frame: 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.

  21. Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Scaling

    Time frame: 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.

  22. Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Skin Scaling

    Time frame: 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.

  23. Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Skin Scaling

    Time frame: 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.

  24. Mean Change from Baseline to Week 2 in Clinical Grading of Tactile Roughness

    Time frame: 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.

  25. Mean Change from Baseline to Week 4 in Clinical Grading of Tactile Roughness

    Time frame: 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.

  26. Mean Change from Baseline to Week 6 in Clinical Grading of Tactile Roughness

    Time frame: 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.

  27. Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Tactile Roughness

    Time frame: 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.

  28. Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Tactile Roughness

    Time frame: 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.

  29. Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Tactile Roughness

    Time frame: 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.

  30. Mean Change from Regression Baseline to Regression Day 10 in Clinical Grading of Tactile Roughness

    Time frame: 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.

  31. Mean Change from Regression Baseline to Regression Day 14 in Clinical Grading of Tactile Roughness

    Time frame: 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.

  32. Mean Change from Baseline to Week 2 in Clinical Tolerance Grading

    Time frame: 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.

  33. Mean Change from Baseline to Week 4 in Clinical Tolerance Grading

    Time frame: 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.

  34. Mean Change from Baseline to Week 6 in Clinical Tolerance Grading

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  40. Mean Change from Baseline to Week 4 in TEWL

    Time frame: 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.

  41. Mean Change from Baseline to Week 6 in TEWL

    Time frame: 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.

  42. Mean Change from Regression Baseline to Regression Day 1 in TEWL

    Time frame: 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.

  43. Mean Change from Regression Baseline to Regression Day 4 in TEWL

    Time frame: 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.

  44. Mean Change from Regression Baseline to Regression Day 7 in TEWL

    Time frame: 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.

  45. Mean Change from Regression Baseline to Regression Day 10 in TEWL

    Time frame: 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.

  46. Mean Change from Regression Baseline to Regression Day 14 in TEWL

    Time frame: 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.

  47. Mean Change from Baseline to Week 4 in Skin Hydration

    Time frame: 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.

  48. Mean Change from Baseline to Week 6 in Skin Hydration

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  54. Mean Change from Baseline to Week 4 in Skin Flaking using D-Squames

    Time frame: 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.

  55. Mean Change from Baseline to Week 6 in Skin Flaking using D-Squames

    Time frame: 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.

  56. Mean Change from Baseline to Week 4 in NMFs using D-Squames

    Time frame: 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.

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

    Time frame: 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.

  58. Mean Change from Baseline to Week 4 in Epidermal Lipids

    Time frame: Baseline to Week 4

    Special adhesive tapes were used to collect and analyze epidermal lipid samples from the skin surface.

  59. Mean Change from Baseline to Week 6 in Epidermal Lipids

    Time frame: Baseline to Week 6

    Special adhesive tapes were used to collect and analyze epidermal lipid samples from the skin surface.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 12, 2020
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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