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. 2020 Jul 7;2020(7):CD008946. doi: 10.1002/14651858.CD008946.pub3

NCT03454945.

Study name Efficacy of doxycycline in the treatment of early stages of mycosis fungoides: a randomizedcControlled yrial
Methods This is a randomised controlled trial comparing vibramycin vs. UVA + psoralen in patients with mycosis fungoides.
Participants Inclusion Criteria
  • Age >18

  • Established diagnosis of classic MF


Exclusion Criteria
  • Any variant of MF other than the classic variant

  • Advanced stages of classic MF: Stage IIb, III or IV

  • Pregnant and lactating females

  • Patients with autoimmune diseases e.g. systemic lupus erythematosus (SLE)

  • Patients with solid or haematological malignancies e.g. breast cancer, leukaemia, etc.

  • Patients with any contraindications for doxycycline (e.g. liver disease, kidney disease, photosensitivity, peptic ulcer or patients receiving systemic retinoids).

  • Patients with any contraindication to phototherapy (e.g. any other skin cancers or photosensitivity); or to psoralen (e.g. liver disease)

Interventions Arm I
Oral vibramycin antibiotic100 mg capsule every 12 hours for 3 months
Arm II
UVA + psoralen 3 sessions per week for 3 months
Outcomes Primary outcomes of the study
  • Clinical assessment of the extent of the lesions in body surface area at 3 months


Secondary outcomes of the study
  • Pathological assessment using immunohistochemistry at 3 months

Starting date 2017
Contact information Sponsors and collaborators
None
Investigators
Principal Investigator: Hagar El Sayed
Notes