Comparison of the Efficacy and Safety of Bexarotene and Photo(Chemo)Therapy Combination Therapy and Bexarotene Monotherapy for Cutaneous T-Cell Lymphoma.

INTRODUCTION: Cutaneous T-cell lymphoma (CTCL) is a chronic condition with low malignancy. The combined use of therapeutic agents and photo(chemo)therapy is widely applied for the treatment of CTCL. The efficacy and safety of bexarotene and photo(chemo)therapy combination therapy were previously confirmed in Japanese patients with CTCL. The efficacy and safety of the bexarotene and photo(chemo)therapy combination therapy was compared with bexarotene monotherapy in Japanese patients with CTCL. METHODS: This was a randomized, open-label, two-parallel-group, active-control specified clinical study in Japanese patients diagnosed with CTCL carried out over 8 weeks with a study extension conducted at two institutions. This study was registered in Japan Registry of Clinical Trials (jRCTs041180094). RESULTS: In the combination therapy group, 22 subjects received oral bexarotene (300 mg/m2 body surface area) once daily, followed by bath-psoralen and ultraviolet (UV) A or narrowband UVB. In the monotherapy group, 24 subjects received oral bexarotene (300 mg/m2) once daily. The efficacy analysis using the modified Severity-Weighted Assessment Tool, which included 39 patients, showed a response rate of 81.0% (17/21) in the combination therapy group and 83.3% (15/18) in the monotherapy group. No statistically significant difference was detected between groups. In the combination therapy group, four subjects showed a complete clinical response or complete response, and subjects with a partial response exhibited a high rate of skin lesion resolution, significantly better than in the monotherapy group. In the safety analysis, which included 46 treated subjects (22 in the combination therapy group and 24 in the monotherapy group), no adverse events or adverse drug reactions were reported in either group. CONCLUSION: Both bexarotene and photo(chemo)therapy combination therapy and bexarotene monotherapy were therapeutically effective in Japanese patients with CTCL and well tolerated. Combination therapy led to a higher skin lesion resolution rate and greater therapeutic effects compared with monotherapy. TRIAL REGISTRATION: jRCTs041180094.

This study evaluated the efficacy and safety of bexarotene monotherapy compared with bexarotene and photo(chemo)therapy combination therapy in Japanese patients with cutaneous T-cell lymphoma (CTCL). The study was a randomized, open-label, two-parallel-group, active-control specified clinical study in patients diagnosed with CTCL performed over an 8-week period with a study extension conducted in two institutions. In the combination therapy group, bexarotene (300 mg/m² body surface area) was administered orally once daily to 22 subjects, followed by treatment with bath-psoralen and ultraviolet A (bath-PUVA) or narrowband UVB. In the bexarotene monotherapy group, bexarotene (300 mg/m²) was administered orally once daily to 24 subjects. Efficacy was assessed using the modified Severity-Weighted Assessment Tool. Among the 39 subjects analyzed for treatment efficacy, the response rate of the combination therapy group was 81.0% (17/21) and that of the monotherapy group was 83.3% (15/18). Differences between the two treatment groups were not statistically significant. Of the 21 subjects in the combination therapy group, 4 had a complete clinical response or complete response, and those with a partial response showed a higher skin lesion resolution rate than in the monotherapy group. The safety analysis revealed no reports of adverse events or adverse drug reactions among the 46 treated subjects (combination therapy group = 22; monotherapy group = 24). Thus, both bexarotene and photo(chemo)therapy combination therapy and bexarotene monotherapy were therapeutically effective and well tolerated in Japanese patients with CTCL. Patients receiving the combined therapy, however, showed a higher rate of skin lesion resolution.

Japanese experiment of a complete and objective automatic grading system of facial signs from selfie pictures: Validation with dermatologists and characterization of changes due to age and sun exposures.

OBJECTIVE: To evaluate the capacity of the automatic detection system to accurately grade, from smartphones' selfie pictures, the severity of ten facial signs in Japanese women and their changes due to age and sun exposures. METHODS: A three-step approach was conducted, based on self-taken selfie images. At first, to check on 310 Japanese women (18-69 years) enrolled in the northerner Hokkaido area (latitude 43.2°N), how, on ten facial signs, the A.I-based automatic grading system may correlate with dermatological assessments, taken as reference. Second, to assess and compare age changes in 310 Japanese and 112 Korean women. Third, as these Japanese panelists were recruited according to their usual behavior toward sun exposure, that is, non-sun-phobic (NSP, N = 114) and sun-phobic (SP, N = 196), and through their regular and early use of a photo-protective product, to characterize the facial photo-damages. RESULTS: (a) On the ten facial signs, detected automatically, nine were found significantly (P < .0001) highly correlated with the evaluations made by three Japanese dermatologists (Wrinkles: r = .75; Sagging: r = .80; Pigmentation: r = .75). (b) The automatic scores showed significant changes with age, by decade, of Wrinkles/Texture, Pigmentation, and Ptosis/Sagging (P < .05). (c) After 45 years, a significantly increased severity of Wrinkles/Texture and Pigmentation was observed in NSP vs. SP women (P < .05). A trend of an increased Ptosis/Sagging (P = .09) was observed. CONCLUSION: This work illustrates, for the first time through investigations conducted at home, some impacts of aging and sun exposures on facial signs of Japanese women. Results significantly confirm the importance of sun avoidance coupled with photo-protective measures. In epidemiological studies, the AI-based system offers a fast, affordable, and confidential approach in detection and quantification of facial signs and their dependence with ages, environments and lifestyles.