A controlled, randomized, evaluator-blinded study for the assessment of efficacy and safety of Imazol® Paste and Multilind® Heilsalbe in infants with diaper dermatitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001184-29-DE

Enrollment

102

Registered

2006-04-27

Start date

2006-07-06

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaper dermatitis (diaper rash)

Interventions

Trade Name: Imazol Paste Product Name: Imazol® Paste Pharmaceutical Form: Cutaneous paste INN or Proposed INN: Clotrimazole CAS Number: CAS-Nr. 2359 Concentration unit: % (W/W) percent weight/weight C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the skin symptoms of diaper dermatitis after 7 days of treatment with Imazol® Paste or Multilind® Heilsalbe;Secondary Objective: 1) To compare the skin symptoms of diaper dermatitis after 14 days of treatment 2) To compare the clinical cure rate after 7 days 3) To compare the clinical cure rate after 14 days 4) To compare the global assessment of clinical response by the investigator after 14 days 5) To compare the microbiological cure rate after 14 days 6) To compare the tolerability;Primary end point(s): Total symptom score (TSS5) for skin symptoms after 7 days using a 4-point scale	—

Measure

Time frame

Main Objective: To compare the skin symptoms of diaper dermatitis after 7 days of treatment with Imazol® Paste or Multilind® Heilsalbe;Secondary Objective: 1) To compare the skin symptoms of diaper dermatitis after 14 days of treatment 2) To compare the clinical cure rate after 7 days 3) To compare the clinical cure rate after 14 days 4) To compare the global assessment of clinical response by the investigator after 14 days 5) To compare the microbiological cure rate after 14 days 6) To compare the tolerability;Primary end point(s): Total symptom score (TSS5) for skin symptoms after 7 days using a 4-point scale

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026