Xerosis Cutis Clinical Trial
Official title:
Prospective, Randomized Study on the Skin Functional Parameters to Assess Skin Barrier Improvement After the Use of a Commercially Available Oil Bath Containing 84.75% Soybean Oil Compared to no Bath Additive
Verified date | September 2015 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
Epidermis that lacks moisture and/or sebum presents as dry skin, which is often characterized by a pattern of fine lines, scaling and itching. In dry skin, the barrier function may be compromised. Skin care practices to decrease the risk of development of dry skin and/or to improve dry skin condition have barely been investigated. Bathing with bath oils has been shown to increase skin hydration, thus helping to stabilize skin barrier function. Therefore, the aim of this study is to investigate the effect of bathing every other day on the skin barrier. Functional parameters, such as TEWL, stratum corneum hydration (SCH) and skin-pH (pH) were measured to characterize skin barrier function.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 85 Years |
Eligibility |
Inclusion Criteria: - Signed informed consent, or children whose parent(s) or guardian(s) have given their written informed consent for their child's participation in the study - Child specific written informed consent, if over 7 years of age - Subjects with a general good and stable health condition - Subjects with clinically stable medical conditions - Accept to abstain from sunbathing and solarium during the study - Overall Dry Skin score (ODS) of 1 to 2 at arms and lower legs - TEWL > 12 g/m2/h on the left mid volar forearm Exclusion Criteria: - Any dermatological condition or skin affection which may interfere with the study assessments, e.g. scars - Suffering from porphyria - Suffering from severe photodermatoses according to the judgment of the investigator - Clinically significant, possibly unstable medical conditions such as metastatic tumor - Currently having other malignant or benign tumors of the skin in the investigational area - Any other acute or chronic pathology that may interfere with the study conduct in the investigator's opinion - Known allergy or intolerance to any ingredients of the study product, e.g. propylene glycol - Use of (medical) oil-containing bath additives or other oil-containing cleansers - Current topical or systemic treatment affecting the skin, e.g. diuretics - Treatment of dry and/or inflammatory skin conditions with topical corticosteroids during the 4 weeks before inclusion - Systemic immunosuppressive or immunomodulatory therapy - Topical retinoids applied during the 6 weeks before inclusion - Topical application of immunosuppressive treatment during the 6 weeks before inclusion - Therapeutic UV-Radiation during the 6 weeks before inclusion - Increased UV-exposure during the 6 weeks before inclusion |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Universitätsmedizin Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Transepidermal water loss (TEWL) in g/m2/h at the left mid volar forearm | Day 28 +/- 3 | No | |
Secondary | Transepidermal water loss (TEWL) in g/m2/h at the left mid volar forearm | Day 14 +/- 2 | No | |
Secondary | Transepidermal water loss (TEWL) in g/m2/h at the right lateral lower leg | Day 14 +/- 2 | No | |
Secondary | Transepidermal water loss (TEWL) in g/m2/h at the right lateral lower leg | Day 28 +/- 3 | No | |
Secondary | Stratum corneum hydration (SCH) in arbitrary units at the right lateral lower leg and left volar forearm | Day 14 +/- 2 | No | |
Secondary | Stratum corneum hydration (SCH) in arbitrary units at the right lateral lower leg and left volar forearm | Day 28 +/- 3 | No | |
Secondary | Skin surface mean roughness (Ra) in µm at the right lateral lower leg and left volar forearm | Day 14 +/- 2 | No | |
Secondary | Skin surface mean roughness (Ra) in µm at the right lateral lower leg and left volar forearm | Day 28 +/- 3 | No | |
Secondary | Skin surface mean roughness (Rz) in µm at the right lateral lower leg and left volar forearm | Day 14 +/- 2 | No | |
Secondary | Skin surface mean roughness (Rz) in µm at the right lateral lower leg and left volar forearm | Day 28 +/- 3 | No | |
Secondary | Skin surface pH at the right lateral lower leg and left volar forearm | Day 14 +/- 2 | No | |
Secondary | Skin surface pH at the right lateral lower leg and left volar forearm | Day 28 +/- 3 | No | |
Secondary | Overall Dry Skin (ODS) score at the right and left lateral lower legs, at the left and right arms, at the trunk | Day 14 +/- 2 | No | |
Secondary | Overall Dry Skin (ODS) score at the right and left lateral lower legs, at the left and right arms, at the trunk | Day 28 +/- 3 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05046015 -
Comparison Dry Foot Skin Between Diabetic and Non-diabetic Subjects and the Effects of Two Cosmetic Foot Care Products
|
N/A | |
Completed |
NCT02216526 -
Skin Health and Effectiveness of Standardized Skin Care Regimens in Nursing Home Residents
|
N/A | |
Completed |
NCT03824886 -
Enhancing SKIN Health and Safety in Aged CARE
|
N/A | |
Completed |
NCT03093597 -
Skin Barrier Biophysical Properties and Clinical Appearance After Moisturizer in Dry Skin
|
N/A | |
Active, not recruiting |
NCT03815305 -
Effect of Centella Asiatica on Xerotic Skin in Diabetes Mellitus Type 2
|
Phase 4 | |
Recruiting |
NCT05639933 -
Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors
|
Phase 2 | |
Completed |
NCT04253704 -
Effects of 2% IDL Lotion on Skin Hydration and Transepidermal Water Loss in Females With Dry Skin
|
Phase 1/Phase 2 | |
Completed |
NCT06178367 -
Effectiveness and Safety of Topical Hyaluronic Acid of Different Molecular Weights in Xerotic Skin Treatment
|
Phase 3 | |
Completed |
NCT04127513 -
Comparison of 12% Ammonium Lactate and 10% Urea Cream in Geriatric With Xerosis Cutis
|
Phase 3 |