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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT01149759
Eligibility Criteria:
Inclusion Criteria:
* Severe AD (defined as having a mean SCORAD score\> 40,, with significant disease activity, pruritus, and sleep disturbances (13), suitable for treatment with Cyclosporine, and have failed or unsuitable for other treatment modalities, including topical and or systemic steroids or phototherapy. Patients must also have an IGA score of 3 or greater,
* Males and females age 18 and above (if females are of child-bearing potential they must agree to use acceptable contraception during the study).
* No systemic treatment contraception must commence 2 weeks prior to initiating the drug.
* No systemic treatment for 4 weeks, no topical treatment or phototherapy for 2 weeks
Exclusion Criteria:
* Previously treated with cyclosporine and had unacceptable toxicity
* Past or current history of malignancy (except for treated isolated skin cancers)
* Renal, hepatic, and hematologic laboratory values greater than CTC grade 1 toxicity, such as but not limited to creatinine \>1.5 ULN, SGOT\>2.5 ULN. Values greater then grade 1 would most likely represent clinically significant renal, hepatic or hematologic disease
* Stage I hypertension is defined as \>140/90. Patients with this blood pressure or higher on two separate occasions, whether on medications or not, will be excluded (JNC guidelines www.nhlbi.nih.gov/guidelines/hypertension )
* Significant lipid panel abnormality (any grade 1 toxicity on CTC scale)
* Lactating females
* Other medical condition that would increase the risk of cyclosporine toxicity
* Positive PPD
* Primary or secondary immune deficiency (including known HIV status)
* Possible or known pregnancy
* Serious infection (such as active hepatitis)
* Drug or alcohol abuse
* Inability or lack of willingness to co-operate with regular monitoring
* Severe photodamage/precancerous skin lesions due to previous sunlight exposure, or photo/photochemotherapy
* Concurrent use of PUVA or UVB, other radiation therapy,
* Concurrent use of other immunosuppressive agents such as MTX, Immuran, Cyclophosphamide, Cellcept, etc.(because of the possibility of excessive immunosuppression and the subsequent risk of malignancies)
* Active infections, infections or history of serious infection requiring hospitalization, antibiotics, antivirals,or antifungals within 30 days of baseline
* History of other inflammatory skin conditions (such as psoriasis, pemphigus, etc.
* Patients with background skin conditions that might be directly related to atopic dermatitis (such as post inflammatory hyperpigmentation) will not be excluded as well as common background non-inflammatory skin conditions such as seborrheic keratosis, benign pigmented lesions, acne, etc
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01149759
Study Brief:
Protocol Section:
NCT01149759