Clinical TrialID 6652
PUVA Maintenance Therapy in Mycosis Fungoides
NCT01686594
Patch/Plaque Stage Mycosis Fungoides
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 6652
- Evidence Id
- 6652
- Core Evidence Id
- 6652
- Source Clinical Trial Id
- 6638
- Herb2 Clinical Trial Id
- HBCT006638
- Nct Id
- NCT01686594
- Title
- PUVA Maintenance Therapy in Mycosis Fungoides
- Status
- Completed
- Phase
- Phase 3
- Study Result
- No
- Study Condition
- Patch/Plaque Stage Mycosis Fungoides
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: 8-methoxypsoralen
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 28
- Outcome Measure
- Recurrence after complete remission within 12 months post therapy, Recurrence is defined as mSWAT (modified severity weighted assessment tool ) \>0. The primary outcome will be evaluated by survival analysis (log-rank test; Kaplan-Meier) comparing time to recurrence after complete remission between patients treated with maintenance therapy vs. patients without maintenance therapy., 12 months after end of therapy
- Sponsor Collaborator
- Medical University of Graz
- Funded By
- OTHER
- Location
- Medical University of Graz, Graz, 8010, Austria|Department of Dermatology, Medical University of Innsbruck, Innsbruck, A-6020, Austria|Department of Dermatology, General Hospital of the City of Linz, Linz, A-4021, Austria|Department of Dermatology, Hospital Salzburg - Paracelsus Private Medical University, Salzburg, A-5020, Austria|Department of Dermatology, County Hospital St. Pölten, St. Pölten, A-3100, Austria|Department of Dermatology, Medical University of Vienna, Vienna, A-1090, Austria|Department of Dermatology, Hospital Hietzing, Vienna, A-1130, Austria|Department of Dermatology, Klinikum Wels, Wels, A-4600, Austria|Department of Dermatology, County Hospital Wiener Neustadt, Wiener Neustadt, A-2700, Austria
- Other Id
- EudraCT 2012-000212-28|24-169 ex 11/12
- Start Date
- 2013-02
- Primary Completion Date
- 2018-07-02
- Completion Date
- 2018-07-02
- First Posted
- 2012-09-18
- Results First Posted
- Last Update Posted
- 2018-11-14
- Study Document
- Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/94/NCT01686594/Prot_SAP_000.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT01686594
- Title Cn
- Title En
- PUVA Maintenance Therapy in Mycosis Fungoides
- Bilingual Status
- semi_complete