Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Anti-aging Efficacy and Skin Radiance-enhancing Effect of Dermial®.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Change in Facial Skin Glow
研究概览
简要总结
The present clinical study has been designed to evaluate the efficacy and safety of Dermial® at a daily dose of 60 mg on skin brightness, hydration, luminosity and other signs of facial skin aging in healthy women aged 35 to 65 years presenting physiological age-related skin aging, compared with placebo over a 12-week supplementation period.
详细描述
This study is a randomized, double-blind, placebo-controlled, single-centre clinical trial designed to evaluate the effects of Dermial® on skin brightness and facial skin ageing in healthy women presenting physiological age-related skin ageing.
A total of 146 healthy women aged 35 to 65 years will be enrolled and randomized in a 1:1 ratio to receive either Dermial® (60 mg/day) or placebo for a 12-week supplementation period. Eligible participants must present moderate signs of facial skin ageing, corresponding to Glogau Grade II or III, and meet predefined inclusion and exclusion criteria.
The primary objective of the study is to assess the effect of Dermial® on facial skin brightness, measured in the right periocular area (crow's feet region) after 12 weeks of supplementation compared with placebo.
Secondary objectives include the evaluation of skin brightness in additional facial areas, skin luminosity, stratum corneum hydration, skin pH, skin ageing parameters (wrinkles, roughness, scaling and smoothness), investigator-assessed facial ageing, participant self-assessment of facial appearance, overall product satisfaction, and product safety.
Safety and tolerability will be evaluated throughout the study by monitoring adverse events and treatment compliance. Assessments will be performed at baseline, 3 weeks, 6 weeks and 12 weeks, including instrumental skin measurements, standardized facial photography, investigator evaluations and participant questionnaires.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willing and able to comply with all study requirements and restrictions, provide informed consent, understand and complete study questionnaires, and undergo all study-related procedures.
- •Healthy women aged 35 to 65 years (inclusive) presenting signs of physiological facial skin ageing, defined as Grade II (Expression Wrinkles) or Grade III (Wrinkles at Rest) according to the Glogau Scale, as assessed by the investigator.
- •Body mass index (BMI) between 18.0 and 34.9 kg/m² (inclusive). Willingness to maintain their usual cosmetic treatment routine throughout the study.
- •Willingness to refrain from undergoing any facial rejuvenation treatments during the study.
- •Willingness not to initiate nutritional supplements containing ingredients with potential skin-related effects during the study (e.g., hyaluronic acid, collagen, methylsulfonylmethane, vitamin C, soy, CoQ10, or antioxidants).
- •Willingness not to initiate the use of new topical products other than those included in their usual skincare routine during the study.
- •Willingness to maintain their normal lifestyle habits throughout the study (including sun exposure, diet, physical activity, and sleep habits).
- •Women willing not to initiate or modify estrogen- or progesterone-based therapies during the study.
- •Women willing to avoid pregnancy during the study by using appropriate contraceptive methods.
- •Women willing not to use any skin-firming, skin-lightening, topical, or systemic medication known to affect skin ageing or dyschromia during the study period.
排除标准
- •Regular use of hyaluronic acid-containing creams within the 3 months prior to enrolment.
- •Regular use of oral supplements that may affect skin condition within the 3 months prior to enrolment.
- •Changes in facial or body cosmetic routines within 1 month prior to enrolment.
- •Use of medications affecting skin responses (e.g., glucocorticoids, antihistamines, immunomodulators).
- •Presence of skin pigmentation disorders.
- •Chronic sun exposure or planned use of tanning beds within 1 month prior to enrolment or during the study.
- •Facial rejuvenation treatments (e.g., microneedling, needle mesotherapy, medium/deep chemical peels, ablative laser treatments, electrotherapy, intense pulsed light therapy) within the 4 months prior to enrolment.
- •Self-reported allergy to cosmetic products and/or sunscreens.
- •Use of hormonal contraceptives for less than 3 months before enrolment, or a change in contraceptive method within the 3 months prior to enrolment in women of childbearing potential.
- •Employees of clinical laboratories, testing companies, cosmetic manufacturers, suppliers of topical product raw materials, or related industries.
- •Pregnant, breastfeeding, or planning to become pregnant during the study.
- •Known hypersensitivity, intolerance, or allergy to any study product, excipient, or rescue medication.
- •Presence of inflammatory facial skin disorders at enrolment, including psoriasis, atopic dermatitis, rosacea, acne, or hidradenitis suppurativa.
- •Type 1 diabetes, uncontrolled type 2 diabetes, uncontrolled hypertension (≥140 mmHg systolic or ≥90 mmHg diastolic), or uncontrolled thyroid disease.
- •Known diseases interfering with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel syndrome, acute or chronic pancreatitis, pancreatic insufficiency).
- •History of cardiovascular disease, kidney disease (including dialysis or renal failure), liver disease, immune disorders, or immunocompromised conditions (e.g., HIV/AIDS).
- •History of cancer (except localized non-metastatic skin cancer or cervical carcinoma in situ) with recovery occurring within 5 years prior to enrolment.
- •Severe psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia) or psychiatric hospitalization within 12 months prior to enrolment.
- •Clinically significant illness reported within 28 days prior to enrolment.
- •Major surgery within the 3 months prior to enrolment or planned during the study.
- •History of alcohol or substance abuse within 12 months prior to enrolment, including hospitalization for intervention programs, or any use considered by the investigator to pose a study risk.
- •Current participation or participation within the previous 2 months in another clinical study involving an investigational product, or prior investigational products with residual effects that may affect eligibility or study outcomes.
- •Any medical condition, clinical situation, medication, supplement, or therapy that, in the investigator's opinion, may interfere with study participation, study assessments, participant safety, or study integrity.
- •Treatment with Botulinum toxin (Botox®), hyaluronic acid fillers, or platelet-rich plasma (PRP) within the 6 months prior to enrolment, or collagen biostimulators within the 12 months prior to enrolment.
- •Participants who have undergone:
- •Superficial or medium-depth chemical peels, or dermabrasion, within 6 weeks prior to enrolment.
- •Facial plastic surgery or ablative laser treatment for photoageing within 12 months prior to enrolment.
研究组 & 干预措施
DERMIAL
Hyaluronic acid matrix ingredien
干预措施: DERMIAL (Dietary Supplement)
PLACEBO
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change in Facial Skin Glow
时间窗: Baseline (week 0) to week 12 (primary analysis at week 12; assessments at weeks 3, 6 and 12)
Facial skin gloss will be measured at the right periocular area using the Skin-Glossymeter® GL 200 probe. Skin gloss values will be expressed in arbitrary units (AU), with a measurement range of 0 to 100 AU. Results will be reported as the mean change from baseline to Week 12. Higher values indicate greater skin gloss.
次要结局
- Change in Skin Glow at Additional Facial Areas(Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12))
- Change in Facial Skin Radiance(Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12))
- Change in Facial Stratum Corneum Hydration(Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12))
- Change in Facial Skin pH(Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12))
- Mean Change From Baseline in Facial Wrinkle (SEw)(Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12))
- Mean Change From Baseline in Facial Skin Smoothness (SEsm)(Baseline (Week 0) to Week 12 (assessments at Weeks 3, 6, and 12))
- Mean Change From Baseline in Facial Skin Roughness (SEr)(Baseline (Week 0) to Week 12 (assessments at Weeks 3, 6, and 12))
- Mean Change From Baseline in Facial Skin Scaliness (SEsc)(Baseline (Week 0) to Week 12 (assessments at Weeks 3, 6, and 12))
- Change in Glogau Photodamage Scale Classification(Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12))
- Change From Baseline in Global Aesthetic Improvement Scale (GAIS) Score(Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12))
- Participant Satisfaction With the Study Product Assessed by 5-Point Likert Scale(Week 12)
- Number of Participants With Adverse Events(Baseline (week 0) to week 12)