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

NCT00583895 | Terminated Phase 2

• 1 other identifier: VAL-UOP-C201
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Atopic Dermatitis

Keywords

dermatitis; atopic; ImCOOH; safety; tolerability; efficacy; pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Topical Atopic Dermatitis Severity Index (toADSI) score

  screening, predose on Day 1 and on Day 2, 7, 9 and 15

• Visual Analogue Scale for Pruritis (VAS) score

  Screening, Day 1 predose, Day 2, 7, 9, 12 and 15

Secondary Outcomes (2)

• Eczema Area and Severity Index (EASI) score

  Day 1 predose, Day 7 and 15

• ImCOOH plasma and urine concentrations

  Day 1 and 15 (plasma) up to 12 hours postdose and predose on Day 2, 4, 7, 9 and 12. Day 15(urine) up to 12 hours postdose

Study Arms (2)

1

ACTIVE COMPARATOR

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: 10% ImCOOH cream

2

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

10% ImCOOH cream DRUG

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.

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged between 18 and 70 years, extremes included.
• Skin type I, II, III, or IV.
• Able to comply with protocol requirements.
• Informed Consent Form (ICF) signed voluntarily before the first trial-related activity.
• Nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection.
• Normal weight as defined by a Quetelet Index (Body Mass Index \[BMI\]: weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included.
• Patients having atopic dermatitis according to the integrated list with criteria for atopic dermatitis.
• 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. Both target areas should be located at the arms (armpits \[axillas\] are also allowed) or both target areas should be located at the hollows of the knee.
• Topical Atopic Dermatitis Severity Index (toADSI) score of at least 5 for both target areas and the severity of the 2 sites do not differ by more than 3 points.
• General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.

You may not qualify if:

• Female subject of childbearing potential without use of effective birth control methods, or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period;
• Note: Estrogen based hormonal contraception may not be reliable when ImCOOH cream is applied, therefore to be eligible for this trial, women of childbearing potential should either:
• use a double barrier method to prevent pregnancy (i.e., using a condom with either diaphragm or cervical cap);
• use hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom);
• use an intrauterine device in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom);
• be only non-heterosexually active, practice heterosexual abstinence, or have a vasectomized partner (confirmed sterile).
• Women with tubal ligation are required to use 1 non-hormonal contraceptive method.
• Women who are postmenopausal for at least 2 years, and women with total hysterectomy are considered of non-childbearing potential.
• A positive pregnancy test or breast feeding at screening.
• A positive HIV-1 or -2 test at trial screening.
• Hepatitis B infection (confirmed by hepatitis B surface antigen) or hepatitis C infection (confirmed by hepatitis C virus antibody) at trial screening.
• Having a target area that is hairy in such extent that in the investigator's opinion it could influence the application.
• Having a target area that is tattooed.
• Unable to take venous blood samples for pharmacokinetics (PK) outside the elbow fold (fossa cubitus) area in case both elbow folds are part of the target areas.
• Patients receiving radiation therapy, systemic therapy with cytostatics or immunosuppressive drugs within 24 weeks before the first application of trial medication.

Sponsors & Collaborators

• Valletta Health B.V.: lead

Study Sites (1)

InPEC B.V. (Clinical Research Unit)

Torremolinos, Malaga, 29620, Spain

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jan D Bos, M.D., Ph.D, FRCP

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 2, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 1, 2010

Record last verified: 2010-02

Locations

ES (1)