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| ID | Type | Description | Link |
|---|---|---|---|
| CCSSKA004090 | Other Identifier | Johnson & Johnson Consumer Inc. (J&JCI) |
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The purpose of this study is to evaluate the efficacy and tolerance of a gentle facial cleanser in participants with sensitive skin (eczema/atopic dermatitis, rosacea, acne, cosmetic intolerance syndrome).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-marketed Cosmetic Facial Cleanser | Experimental | Participants will receive non-marketed cosmetic facial cleanser to apply on cleanse facial skin, twice daily for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-marketed Cosmetic Facial Cleanser | Other | Participants will apply non-marketed cosmetic facial cleanser on cleanse facial skin, twice daily for 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mildness of the Facial Cleanser in Participants with Sensitive Skin Based on Investigator and Participant Assessments | Mildness of the facial cleanser in participants with sensitive skin (eczema/atopic dermatitis, rosacea, acne, cosmetic intolerance syndrome) based on investigator and participant assessments will be reported. It will be evaluated on a scale of 0 to 4 with 0=none, 1=almost clear, 2=mild, 3=moderate, 4=severe. | Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Assessment for Tolerability | Investigator observed tolerability parameters such as: redness/erythema, rash/irritation, peeling/flaking, tactile roughness, and dryness which will be measured using a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe). | Baseline, Week 2 and Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zoe Diana Draelos, MD | Dermatology Consulting Services, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Consulting Services, PLLC | High Point | North Carolina | 27262 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3377516 | Background | Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available. | |
| Background | U.S. Census Bureau. (n.d.). About race. Retrieved July 27, 2021, from https://www.census.gov/topics/population/race/about.html | ||
| Background | U.S. Census Bureau. (n.d.). About the Hispanic population and its origin. Retrieved July 27, 2021, from https://www.census.gov/topics/population/hispanic-origin/about.html |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D012393 | Rosacea |
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Investigator Assessment for Efficacy |
Investigators observed efficacy parameters such as: visual smoothness, tactile softness, clarity, radiance, pores, and overall skin appearance which will be measured using a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe). |
| Baseline, Week 2 and Week 4 |
| Participant Assessment for Tolerability | Participants observed tolerability parameters such as: stinging, burning, itching, tightness, redness, flaking/peeling, roughness, dryness and overall sensitivity which will be measured using a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe). | Baseline, Week 2 and Week 4 |
| Participant Assessment for Efficacy | Participants observed efficacy parameters such as: smoothness, softness, clarity, radiance, pores and overall skin appearance which will be by using a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe). | Baseline, Week 2 and Week 4 |
| Photographic Imaging (Right, Left and Frontal Face with Standard Lighting 1 and Cross Polarized Light) | Photographic imaging (right, left and frontal face with standard lighting 1 and cross polarized light) will be obtained by using VISIA. Each participant's face will be imaged using the photographic imaging system prior to any product use. The imaging system takes a series of two high-resolution images that are captured sequentially in rapid succession to minimize panelist movement and maximize registration of images. Three sets of images will be taken - 45 degree left, 45 degree right, and center of the face. | Baseline, Week 2 and Week 4 |
| Non-invasive Assessment: Transepidermal Water Loss (TEWL) | TEWL measurements of defined target sites of face will be reported. A decrease in TEWL values reflects an improvement in the barrier properties of the skin. | Baseline, Week 2 and Week 4 |
| Non-invasive Assessment: Skin pH | Skin pH measurements of defined target sites of the face will be reported. | Baseline, Week 2 and Week 4 |
| Non-invasive Assessment: Skin Hydration Measured by Corneometer | Skin hydration of defined target sites of face as measured by Corneometer will be reported. An increase in values reflects an improvement in the hydration of the skin. | Baseline, Week 2 and Week 4 |
| Non-invasive Assessment: Biomarker Tapes | Three D-squame tape strips will be taken from a defined target site on the face. D-Squame Standard Sampling Discs (CuDerm Corporation, Dallas, N) will be used to non-invasively collect skin samples from the forehead. The discs are 2.2 centimeters (cm) in diameter and have a homogenous layer of a medical-grade adhesive, which safely removes stratum corneum components and provides optimum visibility of adhering corneocytes. Samples will be collected for the analysis of various skin biomarkers such as skin flakiness, as well as the integrity of the natural moisturizing factors (NMFs), ceramides, free fatty acids, cholesterol via biochemical assays. | Baseline, Week 2 and Week 4 |
| Non-invasive Assessment: Facial Swabbing | A swabbing technique will be used to collect surface skin microflora to determine the effect of the non-marketed cosmetic facial cleanser on the skin microflora. | Baseline, Week 2 and Week 4 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017486 | Acneiform Eruptions |
| D012625 | Sebaceous Gland Diseases |