- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04510103
A Controlled Clinical Study of 2 Different Moisturizers for the Relief of Dry Skin
A Bilateral, Controlled Clinical Trial to Evaluate 2 Different Moisturizer Chassis Formulas for the Relief of Dry Skin
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80915
- Thomas J. Stephens & Associates, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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):
|
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):
|
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):
|
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):
|
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):
|
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):
|
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):
|
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):
|
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
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
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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