Efficacy and Tolerance Evaluation of an Anti-age Food Supplement: a Randomized, Controlled Clinical Study Versus Untreated Group

Derming SRL0 个研究点目标入组 66 人开始时间: 2016年10月11日最近更新: 2017年9月6日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Derming SRL
入组人数: 66
主要终点: Nasolabial folds visual score variation

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Efficacy and Tolerance Evaluation of an Anti-age Food Supplement: a Randomized, Controlled Clinical Study Versus Untreated Group

详细描述

Aim of the study was to evaluate the anti-age activity of "Pre-Hyaluron 465 Innēov" a food supplement, composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese), taken for 4 consecutive months by female subjects aged 35-60 years (with preference for subjects over 45 years), with moderate-severe skin aging/photoaging according to a reference photographic scale.

The study foresaw the evaluation of the study product activity versus a control group, untreated.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 35 Years 至 60 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•female sex,
•age 35-60 years (with preference for subjects over 45 years),
•body mass index (BMI) 18-27,
•caucasian healthy subjects with moderate-severe cutaneous aging/photoaging (score > 3 of the reference photographic scale in appendix 8),
•agreeing to present at each study visit without make-up,
•accepting to follow the instructions received by the investigator,
•accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products,
•agreeing not to apply any topical or take any oral product or nutritional supplementation (vitamins and minerals) other than the investigational products, or use face massages or other means known to improve skin wrinkles or skin qualities during the entire duration of the study,
•accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study,
•no participation in a similar study actually or during the previous 3 months
•accepting to sign the Informed consent form.

排除标准

•Pregnancy,
•lactation,
•subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study,
•subjects not in menopause who do not accept to perform the pregnancy test at T0, T1, T2 and T3,
•sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit);
•subjects whose insufficient adhesion to the study protocol is foreseeable.
•Dependent on a clinical condition 4.4.2.
•Dermatological disease,
•Presence of cutaneous disease on the tested area as lesions, scars, malformations,
•recurrent facial/labial herpes,
•clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).
•Endocrine disease,
•hepatic disorder,
•renal disorder,
•cardiac disorder,
•pulmonary disease,
•neurological or psychological disease,
•inflammatory/immunosuppressive disease,
•drug allergy.
•Anti-inflammatory drugs, anti-histaminic, topic (application on the face) and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of hormonal treatment starting more than 1 year ago),
•assumption of drugs or dietary supplements able to influence the test results in the investigator opinion.

研究组 & 干预措施

Pre-Hyaluron 465 Innēov

Experimental

43 caucasian female subjects have taken during a meal, for the first 4 months of trial,1 capsule and 1 tablet/die of the food supplement composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese) .

干预措施: Pre-Hyaluron 465 Innēov (Dietary Supplement)

Untreated group

No Intervention

23 caucasian female subjects untreated