ISRCTN89244753已完成未知
Photoprotective and antiaging effect of a standardized red orange (Citrus sinensis (L.) Osbeck) extract in Asian and Caucasian subjects: a randomized, double blind, controlled study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- BIONAP srl
- 入组人数
- 110
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35684041/ (added 13/06/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Female and male healthy subjects (between 30-50% male and 50-70% female)
- •2. 35 = age = 65 years old
- •3. 40% Caucasian (skin phototype* I to III) and 60% Asian (skin phototype* III to V) ethnicity
- •4. Mild to moderate skin aging sign including dark spots (grade 2-4; Skin Aging Atlas by Bazin R.)
- •5. Registration with health social security or health social insurance (if required by national regulations)
- •6. Promise to not use during all the study period topic products/food supplements with similar effect to that one of the product to be tested (antioxidant)
- •7. Commitment to sign the informed consent form (ICF)
- •8. Truthfulness of the personal information declared to the Investigator
- •9. Ability to understand the language used in the investigation centre and the information given
- •10. No recent participation in any other similar study
- •11. No sun exposure (both natural and artificial) for at least two months before study start,
- •12. Absence of sunburn, suntan, scars or other active dermal lesions on the area selected for test purposes
- •13. Color uniformity of the test area (without nevi, blemishes or solar lentigo and without hair)
- •14. Promise to not change the normal daily routine, effective contraceptive therapy
- •15. Ability to comply with the protocol and follow protocol’s constraints and specific requirements
排除标准
- •1. Breastfeeding, pregnancy (or unwillingness to take necessary precautions to avoid pregnancy during the study and for at least 3 months before the inclusion visit [for women of childbearing potential]
- •2. Staring or changing oestrogen-progesterone contraception or hormonal treatment, within the 3 months prior to the study or foreseeing it for the duration of the study
- •3. Allergies or sensitivity to cosmetic products, toiletries, sunscreens, and/or topical drugs
- •4. Dermatological problems in the test area
- •5. Pharmacological treatments (both locally or systemically)
- •6. Positive anamnesis for atopy (allergic hypersensitivity affecting parts of the body not in direct contact with the allergen)
- •7. Use of self-tanning products for at least one month before study start
- •8. Habit to use tanning beds,
- •9. Medication with photosensitizing potential, drugs, and/or food supplements able to induce skin coloring, corticoids, currently or during the month before the study start
- •10. Participation in another clinical trial within the last two weeks prior to the inclusion visit and taking part or planning to participate to another clinical trial during the study in the same or another investigation center
- •11. Deprivation of freedom by administrative or legal decision or under guardianship
- •12. Unavailability to be contacted in case of emergency
- •13. Admission in a sanitary or social facility
- •14. Planning a hospitalization during the study
- •15. Impaired immune system due to immunosuppressive diseases, or use of immunosuppressive medication
- •16. Acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- •17. History of severe reactions from exposure to sunlight (i.e., polymorphous light eruption)
- •18. Long-treatment or intending to have one, in particular with aspirin, products containing aspirin, corticoids, beta blockers (including eye drops), immuno-suppressive and/or desensitization drugs or under any treatment considered by the Investigator liable to interfere with the study data or incompatible with the study requirements
- •19. Vaccination within the 3 weeks prior to the study or intending to be vaccinated during the study
- •20. Any surgery, chemical or physical treatment on the experimental area within the 12 months prior to the study or foreseeing it for the duration of the study
- •21. Personal history of atopic dermatitis, urticaria or severe skin reaction to cosmetics, drugs or domestic products or confirmed contact dermatitis or food allergy
- •22. Artificial UV exposure or excessive exposure to natural sunlight or within the 2 weeks prior to the study or foreseeing UV exposures for the duration of the study (at Investigator’s judgment)
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