Seborrheic Dermatitis on the Face
Conditions
Keywords
seborrheic dermatitis, SEDASI score, antioxidant, skin hydration, split-face randomized controlled trial, Transepidermal water loss
Brief summary
This is a 4-week comparison study between the intervention and control sides of the face. Purposive sampling to recruit 13 patients with seborrheic dermatitis will be conducted in this study. The study will start after researcher has been granted the Ethic Committee Approval. The process of subject recruitment and clinical data collection will take place at the Outpatient Department (OPD) while photograph taking and skin measurement will take place at Laser Center and Bioengineering Department, respectively. All bioengineering instruments will be operated under the climate controlled environment; i.e, at temperature 20+/-2 degree Celsius and 50+/-2 % of relative humidity. A subject must get acclimatized to the ambient atmosphere for at least 30 minutes. The clinical data, skin barrier function, the quality of life, subject's satisfaction scale will be collected at the first day (D0, as baseline) and 4th week after finishing the test product (Wk4).
Interventions
OTHERAntioxidant moisturizing serum
Antioxidant Moisturizing Serum
Sponsors
Institute of Dermatology, Thailand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: ≥ 18 years old * Gender: Male and Female * Patient who never uses or has stopped using topical corticosteroids/calcineurin inhibitor or other topical treatments exerting anti-inflammatory action (on the face) more than 2 weeks before entering this clinical trials. * Patient who does not use cosmetic containing any oxidants or others that exert anti-oxidant effect(s). If there is any, one must refrain from using them more than 2 weeks before entering this clinical trials.
Exclusion criteria
* Patients with known cases of underlying HIV/AIDS, neurological condition e.g., Parkinson's disease. * Patient associated with any autoimmune diseases and other skin diseases * Patient takes any forms of oral immunotherapy more than 2 months up to the first day of clinical trials. * Patients continuously use of topical corticosteroids or other anti-inflammatory medicines on regular basis up to the first day of clinical trial. * Patient who refuses to stop using cosmetic(s) containing anti-oxidants or those exert anti-oxidant effect(s). * Patient who is allergic to the test product or one of its ingredients. * Pregnancy or nursing woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SEDASI score | 1 year | To compare clinical improvement as assessed by SEDASI score, between the intervention and control sides of the face in subjects with mild to moderate seborrheic dermatitis after 4 weeks of application of Institute of Dermatology's antioxidant moisturizing serum. This study uses split-face design. Due to the split-face study design and use of the SEDASI score, the same scoring scales were applied for extension (area, 0-6), presentation pattern (0-3), erythema (0-3), and scaling (0-3). The nasal area was excluded because split application to the nose is impractical. The original severity classification was therefore divided by two to obtain a hemiface-specific severity classification. Note: As the nasal area represents approximately 1% of the facial surface and the study compares the two sides of the face, this modification does not affect the primary study objective. The total score may range from 0 (no Seborrheic Dermatitis) to 30 (Seborrheic Dermatitis of the worst possible degree). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Barrier function | 4 weeks | To evaluate skin barrier function, as measured by transepidermal water loss (TEWL) and skin hydration, and surface lipid after 4 weeks of using IOD's antioxidant moisturizing serum. To evaluate facial skin appearance-including glossiness, desquamation, roughness, smoothness, wrinkles, elasticity, and redness-after 4 weeks of using IOD's antioxidant moisturizing serum. |
Countries
Thailand
Contacts
PRINCIPAL_INVESTIGATORVeng Ang Lok, Medical Doctor
Rangsit University
Outcome results
None listed