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Safety and Efficacy Study of ImCOOH Cream in Patients Suffering From Moderate Atopic Dermatitis

NCT00583895 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2010-03-01

No results posted yet for this study

Summary

Atopic dermatitis is one of the most common skin diseases, with a lifetime prevalence of up to 20%, and an increasing number of cases. Although there are a variety of treatments the number of specific medications for treating this chronic disease is limited and often not helpful, especially in more severe cases. In addition,most treatments may be used only for a limited period or are less effective in the long term (tachyphylaxis). The development of new compounds is mandatory for treatment of this often chronically recurring disease. The current trial will determine the efficacy, safety and tolerability of the endogenous compound imidazole-4-carboxylic acid (ImCOOH) administered as a topical cream twice daily for 14 days in patients with atopic dermatitis.

Conditions

Interventions

DRUG

10% ImCOOH cream

Twenty patients will receive a hydrophilic cream containing 10% ImCOOH and a placebo cream randomized over both limbs twice daily for 14 days with an additional morning application on Day 15.

DRUG

Placebo

Five patients will receive placebo cream on both limbs twice daily for 14 days with an additional morning application on Day 15.

Sponsors & Collaborators

  • Valletta Health B.V.

    lead INDUSTRY

Principal Investigators

  • Jan D Bos, M.D., Ph.D, FRCP · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00583895 on ClinicalTrials.gov