UMIN000029537.

Study name	Efficacy and safety of Targretin capsule 75‐mg alone or in combination with phototherapy in Japanese patients with cutaneous T‐cell lymphomas
Methods	This is a randomised controlled trial comparing bexarotene alone vs. bexarotene plus phototherapy for cutaneous T‐cell lymphoma (CTCL) patients.
Participants	Inclusion criteria A clinical diagnosis of cutaneous T‐cell lymphomas (CTCL) confirmed by biopsy to be histologically consistent with CTCL diagnosis by dermatopathologist Age >= 20 Written approval of patient Exclusion criteria Contraindications (severe liver failure, known hypersensitivity to bexarotene, systemic therapy with vitamin A or oral retinoid therapy at the entry in this study, hypervitaminosis A) Patients with pregnancy, breast‐feeding or intent to become pregnant Skin‐directed therapies, local chemotherapy, topical steroids, etc. within 2 weeks of study entry. Low‐ and mid‐potency topical corticosteroids were allowed only for participants using a stable dose regimen at least 2 weeks prior to study entry. High potency topical corticosteroids were not allowed permitted. Prior therapy for the treatment of CTCL: therapy with UVA or UBV within 3 weeks of study entry Prior therapy for the treatment of CTCL: radiotherapy within 4 weeks of study entry Prior therapy for the treatment of CTCL: therapy with bexarotene within4 weeks of study entry Known allergic reaction or hypersensitivity to bexarotene or other component of Targretin capsules History of severe allergic reaction or hypersensitivity to any other drugs or prior therapy for the treatment of CTCL Unwillingness or inability to minimise exposure to sunlight and artificial UV light while receiving bexarotene Principal investigator or sub investigator judged inadequate
Interventions	Arm I Patients receive are administrated a 300 mg/m2 dose of bexarotene orally once daily for 8 weeks. Arm II Patients are administrated a 300 mg/m2 dose of bexarotene orally once daily for 8 weeks. Patients are treated with psoralen baths preceding treatment with UVA radiation 5 times weekly. The initial dose of UVA was 0.5 J/cm2, dose increment of 0.5 J/cm2 each radiation. The maximum dose was 4.0 J/cm2. The initial dose of narrowband UVB administered is 50% to 70% of the MPD or 0.5‐0.7 J/cm2. The dose of NB‐UVB for the subsequent NB‐UVB sessions is elevated 20% increments with each successive treatment session. The maximum dose is 2.0 J/cm2.
Outcomes	Primary outcomes of the study The primary efficacy end points evaluated though the 8 weeks of treatment were follows: Modified Severity‐weighted Assessment Tool (mSWAT), Physician's Global Assessment (PGA). Secondary outcomes of the study Efficacy: time to cutaneous tumour response, time to cutaneous tumour progression, amount of irradiation and UV dose, amount of bexarotene, capsules, and compliance rate, LDH, sIL‐2R, TARC, T‐cell receptor repertoire analysis Safety: adverse events, haematology, blood chemistry
Starting date	2017
Contact information	Sponsors and collaborators Minophagen Pharmaceutical Co., Ltd. Investigators Principal Investigator: Akimichi Morita
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