Clinical trial NCT00583895 (phase 2, status: terminated)
Conditions: atopic dermatitis
ICD codes: L20.89, L20.9
Drugs: 10% imcooh cream, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    recruitment problems; insufficient number of new recruits
  
Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged between 18 and 70 years, extremes included.

          2. Skin type I, II, III, or IV.

          3. Able to comply with protocol requirements.

          4. Informed Consent Form (ICF) signed voluntarily before the first trial-related
             activity.

          5. Nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for
             at least 3 months prior to selection.

          6. 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.

          7. Patients having atopic dermatitis according to the integrated list with criteria for
             atopic dermatitis.

          8. 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.

          9. 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.

         10. General medical condition, in the investigator's opinion, does not interfere with the
             assessments and the completion of the trial.

        Exclusion Criteria:

          1. 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:

               1. use a double barrier method to prevent pregnancy (i.e., using a condom with
                  either diaphragm or cervical cap);

               2. use hormonal based contraceptives in combination with a barrier contraceptive
                  (i.e., male condom, diaphragm or cervical cap, or female condom);

               3. use an intrauterine device in combination with a barrier contraceptive (i.e.,
                  male condom, diaphragm or cervical cap, or female condom);

               4. 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.

          2. A positive pregnancy test or breast feeding at screening.

          3. A positive HIV-1 or -2 test at trial screening.

          4. Hepatitis B infection (confirmed by hepatitis B surface antigen) or hepatitis C
             infection (confirmed by hepatitis C virus antibody) at trial screening.

          5. Having a target area that is hairy in such extent that in the investigator's opinion
             it could influence the application.

          6. Having a target area that is tattooed.

          7. 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.

          8. Patients receiving radiation therapy, systemic therapy with cytostatics or
             immunosuppressive drugs within 24 weeks before the first application of trial
             medication.

          9. Patients receiving phototherapy or systemic therapy for atopic dermatitis within 4
             weeks before the first application of trial medication.

         10. Patients receiving antibiotics or topical therapy for atopic dermatitis within 2 weeks
             before the first application of trial medication. However, once-daily use of 1%
             hydrocortisone acetate is allowed on all lesions with the exception of the test sites
             and emollients are allowed to be used liberally but not on the test sites.

         11. Patients taking antihistamines within 1 week before the first application of trial
             medication.

         12. Patients with any acute skin infection (superinfection or secondary impetiginisation).

         13. Any condition (including but not limited to alcohol and drug use), which in the
             opinion of the investigator could compromise the patient safety or compliance with
             trial procedures.

         14. Any history or currently active allergy such as but not limited to drug allergy, food
             allergy or hay fever.

         15. Previously demonstrated clinically significant allergy or hypersensitivity to any of
             the excipients of the trial medication administered in this trial.

         16. Participation in an investigational drug trial within 30 days prior to the first
             application of trial medication.

         17. Donation of blood or plasma in the 60 days preceding the first application of trial
             medication.

         18. Patients with the following laboratory abnormalities at screening:

               -  serum creatinine > 1.1 x ULN;

               -  hemoglobin ≤ 10.9 g/dL;

               -  platelet count grade ≤ 125 x 109/L;

               -  absolute neutrophil count ≤ 1.3 x 109/L;

               -  aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 1.25 x ULN;

               -  total bilirubin ≥ 1.1 x ULN;

               -  proteinuria or hematuria;

               -  any other moderate or severe laboratory abnormality.