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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT01686594
Eligibility Criteria:
Inclusion Criteria:
* Histopathologically documented MF clinical stage IA-IIB (see Table1) confirmed by current or previous diagnostic lesion biopsy
* A Karnofsky performance score \> 60
* No previous PUVA treatment
* Anti-ds-DNA (antinuclear antibodies) or anti-Ro/La antibodies: negative
* Acceptable organ function defined as follows:
SGOT (AST) and SGPT (ALT) \< 2.5 times the upper limit of normal for the institution
* Creatinine \< 2 times the upper limit of normal for the institution
* No evidence of severe cardiac insufficiency (NYHA grade III-IV)
* Women of child bearing potential must have a negative serum pregnancy test (ß-HCG) within seven (7) days prior to randomization
* Absence of any serious intercurrent illness or infection at time of entry into the study that could interfere with planned treatment
* Patients must be willing to accept limiting sun exposure on the day receiving PUVA treatment
* Written informed consent
Exclusion Criteria:
* Pregnancy and Lactation
* Photosensitive diseases such as lupus erythematosus or basal cell nevus syndrome
* Skin cancer syndromes such as xeroderma pigmentosum or basal cell nevus syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
82 Years
Study:
NCT01686594
Study Brief:
Protocol Section:
NCT01686594