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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
85
Participants will apply non-marketed cosmetic facial cleanser on cleanse facial skin, twice daily for 4 weeks.
Dermatology Consulting Services, PLLC
High Point, North Carolina, United States
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.
Time frame: Baseline to Week 4
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).
Time frame: Baseline, Week 2 and Week 4
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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline, Week 2 and Week 4
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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.
Time frame: 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.
Time frame: Baseline, Week 2 and Week 4
Non-invasive Assessment: Skin pH
Skin pH measurements of defined target sites of the face will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 2 and Week 4