A randomized controlled study of efficacy of topical non-steroidal anti- inflammatory cream in treating mild to moderate seborrheic dermatitis in Thai populatio
Phase 3
Completed
- Conditions
- Patient with mild to moderate seborrheic dermatitisSeborrheic dermatitis, Avenanthramides, Piroctone olamine, Acetamide MEA, Biosaccharide Gum-2, Zinc PCA, Nutradeica DS, Hydrophilic cream
- Registration Number
- TCTR20230811003
- Lead Sponsor
- Chanat Kumtornrut
- Brief Summary
The NSC group's mean mSDASI significantly differed from controls at week 8 (-2.00 [95%CI -3.68, -0.32]). The proportion of subjects achieving successful IGA (more than 80% improvement compared to the baseline) was significantly higher in the NSC group at week 8 (44% vs 16%, p 0.048).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Healthy patients with mild to moderate seborrheic dermatitis
Exclusion Criteria
1. Other active skin diseases that may interfere with the assessment of seborrheic dermatitis severity.
2. History of using topical and oral anti-inflammatory medication within the 4 weeks prior.
3. History of allergy to any component of the product.
4. Pregnancy or breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seborrheic dermatitis severity baseline, 4 weeks, 8 weeks, 12 weeks Modified seborrheic dermatitis area severity index (mSDASI),Investigator Global Assessment 4 weeks, 8 weeks, 12 weeks 5-point ordinal scale (worsening, no response, mild response, good response, excellent response)
- Secondary Outcome Measures
Name Time Method Skin hydration baseline, 4 weeks, 8 weeks, 12 weeks Corneometer,Trans-epidermal water loss baseline, 4 weeks, 8 weeks, 12 weeks Tewameter,Skin sebum baseline, 4 weeks, 8 weeks, 12 weeks Sebumeter,Erythema baseline, 4 weeks, 8 weeks, 12 weeks Colorimeter,Frequency of 0.02% Triamcinolone acetate use within 12 weeks Times and duration of treatment,Patient satisfaction at 12 weeks Patient Satisfaction Scale 0-10,Patient Global Assessment 4 weeks, 8 weeks, 12 weeks 5-point ordinal scale (worsening, no response, mild response, good response, excellent response)