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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT01595893
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of PLE by typical patient history, typical histology of skin lesions and/or positive photo provocation results
Exclusion Criteria:
* Allergy or intolerance to Oleovit D3 or Coconut/palm kernel
* Presence or history of malignant skin tumors
* Dysplastic melanocytic nevus syndrome
* Photosensitive diseases such as porphyria, chronic actinic dermatitis, xeroderma pigmentosum, and basal cell nevus syndrome; autoimmune disorders such as lupus erythematosus or dermatomyositis
* Sarcoid
* Renal dysfunction
* Psychiatric disorder
* Pregnancy or breastfeeding
* Topical treatment with vitamin D derivates within 3 months
* Oral treatment with vitamin D within 6 months
* Antinuclear antibodies such as anti-ds-DNA or anti- Ro/La
* 25-hydroxy vitamin D serum levels \> 30ng/ml at screening visit
* Serum hypercalcemia \> 2,65 nmol/L
* Treatment with thiazides or glycosides
* Systemic treatment with steroids and/or other immunosuppressive drugs within 4 weeks
* UV exposure in test fields within 8 weeks before the start of the study
* General poor health status
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01595893
Study Brief:
Protocol Section:
NCT01595893