Seborrheic dermatitis Skin and Connective Tissue Diseases
Conditions
Interventions
Patients were instructed to apply Nutradeica cream twice daily on the face and on the chest for 14 days. The investigator evaluated their skin condition at first visit and after 7 and 14 days of produ
Sponsors
ISDIN S.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males in otherwise good health 2. Aged 21-65 years at time of enrollment 3. Mild to moderate visible SD on face and chest area
Exclusion criteria
Exclusion criteria: 1. Acute or chronic disease or medical condition that could put participant at risk in the opinion of the Principal Investigator or compromise study outcomes 2. History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc. 3. Immunocompromised 4. Taking other medications (oral or topical) that could interfere with the interpretation of the results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Severity of seborrheic dermatitis assessed using a scoring index (SI) evaluating erythema, desquamation, itching and irritation at baseline and after 7 and 14 days of treatment 2. Seborrheic dermatitis severity assessed using the Investigator's Global Assessment Score (IGA) at baseline and after 7 and 14 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient evaluation of erythema assessed using a visual analog scale at baseline and after 7 and 14 days of treatment 2. Patient evaluation of scaling assessed using a visual analog scale at baseline and after 7 and 14 days of treatment 3. Patient evaluation of itching assessed using a visual analog scale at baseline and after 7 and 14 days of treatment 4. Patient evaluation of sensation of heat assessed using a visual analog scale at baseline and after 7 and 14 days of treatment 5. Patient evaluation of pain assessed using a visual analog scale at at baseline and after 7 and 14 days of treatment 6. Patient evaluation of irritation assessed using a visual analog scale at baseline and after 7 and 14 days of treatment 7. Patient evaluation of seborrheic dermatitis severity change assessed using the Patient Global Assessment (PGA) after 7 and 14 days of treatment 8. Antifungal effect assessed by quantifying Malassezia furfur colony-forming units from skin scrapings at baseline and after 7 and 14 days of treatment 9. Antimicrobial effect assessed by quantifying Staphylococcus epidermidis colony-forming units from skin scrapings and gene expression of antimicrobial peptides (HBD2 and HBD3) at baseline and after 7 and 14 days of treatment 10. Anti-inflammatory effect assessed by quantifying gene expression of IL-1a, IL-1ß, IL-6, IL-8 and TNF-a in skin biopsies at baseline and after 7 and 14 days of treatment 11. Anti-pruritic effect assessed by quantifying gene expression of cathepsin S (CTS) and L-histidine decarboxylase (HDC) in skin biopsies at baseline and after 7 and 14 days of treatment 12. Tolerability assessed by quantifying adverse events recorded by the investigator or reported by patients during the study | — |
Countries
Italy
Contacts
Public ContactJavier Bustos
Outcome results
None listed