A controlled, randomized, evaluator-blinded study for the assessment of efficacy and safety of Imazol® Paste and Multilind® Heilsalbe in infants with diaper dermatitis
- Conditions
- Diaper dermatitis (diaper rash)
- Registration Number
- EUCTR2006-001184-29-DE
- Lead Sponsor
- Spirig Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 102
1) Clinical diagnosis of diaper dermatitis
2) Infants aged between 4 months and 2 years
3) Total symptom score (TSS5) of at least 5.
4) Current diaper dermatitis is present for less than 6 weeks.
5) Written informed consent of the parents or the legal representative
6) Outpatient status
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) Chronic diaper dermatitis >6 weeks duration
2) Known or suspected hypersensitivity to the active ingredients or excipients of the investigational drugs
3) Topical or systemic immunosuppressive therapy (incl. corticosteroids) or congenital immunodeficiency
4) Concomitant skin diseases which could interfere with the assessment of diaper dermatitis, e.g. psoriasis, perianal streptococcal dermatitis, anogenital warts, allergic contact dermatitis
5) Treatment with one of the active ingredients of the study medication within the past 2 weeks
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method