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SkinNCT04510103

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

A study testing Moisturizer A, F#9155-005, Moisturizer B, F#E1387-004 and Regression in people with Skin and Skin Care, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Skin, Skin Care, Skin Cream
What is being tested?
Moisturizer A, F#9155-005, Moisturizer B, F#E1387-004 and Regression
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited States
Study dates
23 Oct 2015to 7 Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Thomas J. Stephens & Associates, Inc.

    Colorado Springs, Colorado, 80915

Other trials in United States

About this study

Official title: A Bilateral, Controlled Clinical Trial to Evaluate 2 Different Moisturizer Chassis Formulas 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.

Being tested
Moisturizer A, F#9155-005, Moisturizer B, F#E1387-004, Regression, Non-Regression
Keywords
Skin, Stratum Corneum, Skin Care, Skin Cream, Dryness, Moisturization, Hydration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 or surgery

    2 week regression period after 6 weeks of moisturizer use.

  • Non-RegressionProcedure or surgery

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

Study groups in NCT04510103
Study groupRoleWhat they receive
Regression GroupOtherThe 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).
Receives: Drug: Moisturizer A, F#9155-005; Other: Moisturizer B, F#E1387-004; Procedure: Regression
Non-Regression GroupOtherThe 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.
Receives: Drug: Moisturizer A, F#9155-005; Other: Moisturizer B, F#E1387-004; Procedure: Non-Regression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Week 6

Secondary outcomes (59)

  1. 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.

    Measured: Baseline to Week 2

  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.

    Measured: Baseline to Week 4

  3. 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.

    Measured: Regression Baseline to Regression Day 1

  4. 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.

    Measured: Regression Baseline to Regression Day 4

  5. 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.

    Measured: Regression Baseline to Regression Day 7

  6. 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.

    Measured: Regression Baseline to Regression Day 10

  7. 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.

    Measured: Regression Baseline to Regression Day 14

  8. 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.

    Measured: Baseline to Week 2

  9. 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.

    Measured: Baseline to Week 4

  10. 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.

    Measured: Baseline to Week 6

  11. 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.

    Measured: Regression Baseline to Regression Day 1

  12. 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.

    Measured: Regression Baseline to Regression Day 4

  13. 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.

    Measured: Regression Baseline to Regression Day 7

  14. 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.

    Measured: Regression Baseline to Regression Day 10

  15. 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.

    Measured: Regression Baseline to Regression Day 14

  16. 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.

    Measured: Baseline to Week 2

  17. 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.

    Measured: Baseline to Week 4

  18. 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.

    Measured: Baseline to Week 6

  19. 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.

    Measured: Regression Baseline to Regression Day 1

  20. 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.

    Measured: Regression Baseline to Regression Day 4

  21. 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.

    Measured: Regression Baseline to Regression Day 7

  22. 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.

    Measured: Regression Baseline to Regression Day 10

  23. 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.

    Measured: Regression Baseline to Regression Day 14

  24. 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.

    Measured: Baseline to Week 2

  25. 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.

    Measured: Baseline to Week 4

  26. 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.

    Measured: Baseline to Week 6

  27. 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.

    Measured: Regression Baseline to Regression Day 1

  28. 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.

    Measured: Regression Baseline to Regression Day 4

  29. 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.

    Measured: Regression Baseline to Regression Day 7

  30. 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.

    Measured: Regression Baseline to Regression Day 10

  31. 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.

    Measured: Regression Baseline to Regression Day 14

  32. 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.

    Measured: Baseline to Week 2

  33. 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.

    Measured: Baseline to Week 4

  34. 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.

    Measured: Baseline to Week 6

  35. 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.

    Measured: Regression Baseline to Regression Day 1

  36. 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.

    Measured: Regression Baseline to Regression Day 4

  37. 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.

    Measured: Regression Baseline to Regression Day 7

  38. 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.

    Measured: Regression Baseline to Regression Day 10

  39. 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.

    Measured: Regression Baseline to Regression Day 14

  40. 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.

    Measured: Baseline to Week 4

  41. 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.

    Measured: Baseline to Week 6

  42. 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.

    Measured: Regression Baseline to Regression Day 1

  43. 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.

    Measured: Regression Baseline to Regression Day 4

  44. 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.

    Measured: Regression Baseline to Regression Day 7

  45. 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.

    Measured: Regression Baseline to Regression Day 10

  46. 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.

    Measured: Regression Baseline to Regression Day 14

  47. 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.

    Measured: Baseline to Week 4

  48. 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.

    Measured: Baseline to Week 6

  49. 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.

    Measured: Regression Baseline to Regression Day 1

  50. 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.

    Measured: Regression Baseline to Regression Day 4

  51. 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.

    Measured: Regression Baseline to Regression Day 7

  52. 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.

    Measured: Regression Baseline to Regression Day 10

  53. 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.

    Measured: Regression Baseline to Regression Day 14

  54. 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.

    Measured: Baseline to Week 4

  55. 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.

    Measured: Baseline to Week 6

  56. 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.

    Measured: Baseline to Week 4

  57. 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.

    Measured: Baseline to Week 6

  58. 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.

    Measured: Baseline to Week 4

  59. 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.

    Measured: Baseline to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2020
  2. Study start23 Oct 2015
  3. Primary completion25 Mar 2016
  4. Study completion7 Apr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04510103
Sponsor's protocol ID
PS-150914160029-SACT
Status last verified
Aug 2020
First submitted
10 Aug 2020
Last updated
12 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Questions about this trial

What is this clinical trial studying?

A study testing Moisturizer A, F#9155-005, Moisturizer B, F#E1387-004 and Regression in people with Skin and Skin Care, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change from Baseline to Week 6 in Clinical Grading of Skin Dryness (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04510103.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.

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