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

August 10, 2020 updated by: Johnson & Johnson Consumer Inc. (J&JCI)

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Colorado Springs, Colorado, United States, 80915
        • Thomas J. Stephens & Associates, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Regression Group
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).
OTC Monograph Drug. Used twice daily on left or right lower leg per randomization schedule.
Cosmetic Moisturizer. Used twice daily on left or right lower leg per randomization schedule.
2 week regression period after 6 weeks of moisturizer use.
OTHER: Non-Regression Group
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.
OTC Monograph Drug. Used twice daily on left or right lower leg per randomization schedule.
Cosmetic Moisturizer. Used twice daily on left or right lower leg per randomization schedule.
Physical insult (tape stripping) on the lower leg after 6 weeks of moisturizer use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 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.
Baseline to Week 4
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.
Regression Baseline to Regression Day 1
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.
Regression Baseline to Regression Day 4
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.
Regression Baseline to Regression Day 7
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.
Regression Baseline to Regression Day 10
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.
Regression Baseline to Regression Day 14
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.
Baseline to Week 2
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.
Baseline to Week 4
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.
Baseline to Week 6
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.
Regression Baseline to Regression Day 1
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.
Regression Baseline to Regression Day 4
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.
Regression Baseline to Regression Day 7
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.
Regression Baseline to Regression Day 10
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.
Regression Baseline to Regression Day 14
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.
Baseline to Week 2
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.
Baseline to Week 4
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.
Baseline to Week 6
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.
Regression Baseline to Regression Day 1
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.
Regression Baseline to Regression Day 4
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.
Regression Baseline to Regression Day 7
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.
Regression Baseline to Regression Day 10
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.
Regression Baseline to Regression Day 14
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.
Baseline to Week 2
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.
Baseline to Week 4
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.
Baseline to Week 6
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.
Regression Baseline to Regression Day 1
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.
Regression Baseline to Regression Day 4
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.
Regression Baseline to Regression Day 7
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.
Regression Baseline to Regression Day 10
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.
Regression Baseline to Regression Day 14
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.
Baseline to Week 2
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.
Baseline to Week 4
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.
Baseline to Week 6
Mean Change from Regression Baseline to Regression Day 1 in Clinical Tolerance Grading
Time Frame: Regression Baseline to Regression Day 1

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
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.
Regression Baseline to Regression Day 4
Mean Change from Regression Baseline to Regression Day 7 in Clinical Tolerance Grading
Time Frame: Regression Baseline to Regression Day 7

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
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.
Regression Baseline to Regression Day 10
Mean Change from Regression Baseline to Regression Day 14 in Clinical Tolerance Grading
Time Frame: Regression Baseline to Regression Day 14

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
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.
Baseline to Week 4
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.
Baseline to Week 6
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.
Regression Baseline to Regression Day 1
Mean Change from Regression Baseline to Regression Day 4 in TEWL
Time Frame: Regression Baseline to Regression Day 4
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
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.
Regression Baseline to Regression Day 7
Mean Change from Regression Baseline to Regression Day 10 in TEWL
Time Frame: Regression Baseline to Regression Day 10
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
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.
Regression Baseline to Regression Day 14
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.
Baseline to Week 4
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.
Baseline to Week 6
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.
Regression Baseline to Regression Day 1
Mean Change from Regression Baseline to Regression Day 4 in Skin Hydration
Time Frame: Regression Baseline to Regression Day 4
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
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.
Regression Baseline to Regression Day 7
Mean Change from Regression Baseline to Regression Day 10 in Skin Hydration
Time Frame: Regression Baseline to Regression Day 10
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
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.
Regression Baseline to Regression Day 14
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.
Baseline to Week 4
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.
Baseline to Week 6
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.
Baseline to Week 4
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.
Baseline to Week 6
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.
Baseline to Week 4
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.
Baseline to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Neena Tierney, Johnson & Johnson Consumer Inc. (J&JCI)
  • Principal Investigator: Kun "Mark" Qian, M.D., Thomas J. Stephens & Associates, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 23, 2015

Primary Completion (ACTUAL)

March 25, 2016

Study Completion (ACTUAL)

April 7, 2016

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (ACTUAL)

August 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • PS-150914160029-SACT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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