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:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT02416258
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated informed consent has been obtained
* Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 6 different products.
* Age 18 years or above
* Outpatients
* Female subjects must be of either
* non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or,
* child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.
Exclusion Criteria:
* Female subjects who are breast feeding
* Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
* Etanercept - within 4 weeks prior to randomisation and during the trial
* Adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial
* Ustekinumab - within 16 weeks prior to randomisation and during the trial
* Other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer)
* Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the trial,
* Subjects using phototherapy within the following time periods prior to randomisation and during the trial:
* PUVA: 4 weeks
* UVB: 2 weeks
* Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial:
* Potent or very potent (WHO group III-IV) corticosteroids
* Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial:
* WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
* Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. calcineurin inhibitors), Tar products, Salicylic acid
* Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial
* Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the trial
* Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02416258
Study Brief:
Protocol Section:
NCT02416258