Facial seborrheic dermatitis (mild to moderate severity) in adults. Seborrheic dermatitis, facial dermatoses, topical therapy, atorvastatin, triamcinolone acetonide, randomized controlled trial, noninferiority trial, treatment efficacy, safety, disease severity index
Conditions
Interventions
In house compounded atorvastatin cream 2 % prepared by mixing atorvastatin tablets with urea based cream. Apply a thin layer to facial seborrheic dermatitis lesions twice daily for 8 weeks.,Triamcinol
Experimental Drug,Active Comparator Drug
Atorvastatin cream,Triamcinolone acetonide cream
Sponsors
Walailak university
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of facial seborrheic dermatitis involving at least one facial area such as forehead, eyebrows, nasolabial folds, or cheeks. 2. Mild to moderate disease severity at screening, based on a validated facial severity score within the protocol-defined range. 3. Disease duration of at least 3 months. 4. Able and willing to apply the assigned study cream to facial lesions twice daily for 8 weeks and attend scheduled visits. 5. Able and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe facial seborrheic dermatitis requiring systemic therapy or judged unsuitable for topical treatment alone. 2. Other facial skin conditions or active skin infection that could interfere with diagnosis, outcome assessment, or safety evaluation. 3. Known hypersensitivity or contraindication to atorvastatin, triamcinolone acetonide, or any component of the study creams. 4. Current use of systemic statins. 5. Use of prohibited concomitant therapies within the protocol-defined washout period, including topical anti-inflammatory, antifungal, or calcineurin inhibitor agents on the face, or systemic corticosteroids, antifungals, isotretinoin, or immunosuppressive therapy. 6. Pregnancy or breastfeeding, or unwillingness to use effective contraception during the study period. 7. Facial cosmetic procedures within the previous 3 months that may affect clinical assessment. 8. Participation in another interventional clinical trial within the previous 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seborrheic dermatitis severity At baseline , at 4 weeks, and at 8 weeks Seborrheic Dermatitis Area and Severity Index for the face | — |
Secondary
| Measure | Time frame |
|---|---|
| Physician global assessment At baseline, 4 weeks, and 8 weeks Physician Global Assessment scale for facial seborrheic dermatitis,Local adverse events At baseline, 4 weeks, and 8 weeks Investigator assessed local tolerability and adverse event recording at each visit | — |
Countries
Thailand
Contacts
Public ContactWeeratian Tawanwongsri
Walailak University
Outcome results
None listed