Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT00689832
Eligibility Criteria:
Inclusion Criteria:
* Children with moderate to severe atopic dermatitis (Rajka \& Langeland score greater than or equal to 4.5) and who had responded insufficiently to conventional therapies
* Female patients of childbearing age: effective means of contraception throughout the period of the study and for four weeks following the end of the study
* Informed consent
* Therapeutic washout for atopic dermatitis treatments
Exclusion Criteria:
* Genetic epidermal barrier defect, such as Netherton's syndrome, or suffering from erythroderma
* Any female patients who were pregnant or breast-feeding
* Clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum
* Superinfected eczema
* Known hypersensitivity to macrolides or to any other excipient in tacrolimus ointment
* Known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation
* Ulcerated lesions, of whatever type
* Moderate to severe acne or rosacea
* Patients participating at the same time in another clinical study or who have participated in another clinical study within 28 days of the start of this study
* substance abuse (including that of drugs and alcohol) or mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up
* Known serologically proven HIV positivity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
15 Years
Study:
NCT00689832
Study Brief:
Protocol Section:
NCT00689832