UV-induced erythema
Conditions
Interventions
tomato juice (once a day for 12 weeks)
Lycopene-rich tomato juice (once a day for 12 weeks)
Placebo (once a day for 12 weeks)
Sponsors
Kagome Co. Ltd.
Inforward, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese Subjects 2) Subjects whose skin will sunburn (form erythema) easily and develop a tan by UV irradiation
Exclusion criteria
Exclusion criteria: 1) Subjects with apparent pigmentation, inflammation, and other diseases in the inside of both upper arms 2) Subjects with history of photo sensitivity 3) Subjects who habitually consume tomato juice or lycopene-rich foods 4) Subjects who use pharmaceuticals and quasi-drugs effective in the treatment of UV-induced skin pigmentation and chloasma 5) Female subjects who is breast-feeding or in pregnancy, or plan to get pregnant during this study period 6) Subjects with risk of allergy regarding to this study 7) Subjects with smoking habit 8) Subjects who habitually consume higher amount of alcohol (> avg 60 g alcohol/day) 9) Subjects who participated in other clinical trials within 2 months. 10) Subjects who are judged unsuitable for this study by principal investigator and doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erythema formation induced by UV radiation at 0, 8, and 12 weeks after beginning the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Increased level of malondialdehyde in stratum corneum, increased pigmentation, and changes in serum carotenoids (lycopene, beta-carotene, etc. and vitamin E) | — |
Countries
Japan
Contacts
Public ContactKazunori Takashima
Inforward, Inc Ebisu Skin Research Center
Outcome results
None listed