Atopic Dermatitis Clinical Trial
Official title:
Phase IIa, Randomized, Double-blind, Placebo-controlled, Intra-individual Left-right Limb Comparison Trial in 25 Patients With Moderate Atopic Dermatitis to Investigate the Efficacy, Local Irritation, Safety, Tolerability and Pharmacokinetics of Twice Daily Topical Applications With 10% ImCOOH Cream for 14 Days With an Additional Morning Application on Day 15.
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.
This is a Phase IIa, randomized, double-blind, placebo-controlled, intra-individual
left-right limb comparison trial to investigate the efficacy, local irritation, safety,
tolerability and pharmacokinetics of multiple topical applications of ImCOOH cream. The
trial population will consist of 25 patients with moderate atopic dermatitis. 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. Five patients will receive placebo cream on both limbs twice daily for 14 days with
an additional morning application on Day 15. The creams will be applied on 2 comparative
target areas (minimum 0.1% and maximum 2% of the total body surface area per target area),
with one site at the left limb and one site at the right limb. The applied creams needs to
be prevented from wiping off. Efficacy will be assessed until Day 15 and safety and
tolerability will be monitored until 14 days after the last application.
Efficacy will be assessed by determining the Topical Atopic Dermatitis Severity Index
(toADSI) score, and the Visual Analogue Scale for Pruritis (VAS) score for both target areas
at screening, predose on Day 1 of treatment and on Days 2, 7, 9, 12 and 15 of treatment. In
addition, color pictures of the target areas will be taken predose on Day 1 of treatment and
on Days 7 and 15 of treatment. Finally the Eczema Area and Severity Index (EASI) score will
be determined for both target areas, predose on Day 1 of treatment and on Days 7 and 15 of
treatment.
Safety will be assessed by monitoring (S)AEs, performing clinical laboratory tests
(hematology, biochemistry, urinalysis) and physical exams and by taking vital signs and
recording ECGs on a regular basis.
For pharmacokinetic analysis, plasma concentrations of ImCOOH will be determined on Days 1
and 15 up to 12 hours postdose. In addition, the morning predose plasma concentration of
ImCOOH will be determined on Days 2, 4, 7, 9, and 12. Full urinary output will be collected
on Day 15 up to 12 hours postdose to determine the amount of unchanged ImCOOH excreted in
urine. In the patients who received the placebo cream only, the endogenous ImCOOH
concentrations in plasma and urine will be measured.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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