Clinical Study to Evaluate the Anti-aging Efficacy and Skin Radiance-enhancing Effect of Dermial®. (Dermiglow)
Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Anti-aging Efficacy and Skin Radiance-enhancing Effect of Dermial®.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Patricia Gálvez Martín, Doctor
- 電話番号:+34 93 765 03 90
- メール:pgalvez@bioiberica.com
研究場所
-
-
Madrid
-
Madrid、Madrid、スペイン、28001
- 募集
- Institute of Advanced Medicine and Dermatology (IMDA)
-
コンタクト:
- Almudena Nuño, Doctor
- 電話番号:+34 91 632 56 59
- メール:almudena@imda.es
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:DERMIAL
Hyaluronic acid matrix ingredien
|
1 cap 60 mg/day
|
|
プラセボコンパレーター:PLACEBO
Placebo
|
プラセボ
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Facial Skin Glow
時間枠: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.
|
Baseline (week 0) to week 12 (primary analysis at week 12; assessments at weeks 3, 6 and 12)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Skin Glow at Additional Facial Areas
時間枠:Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
|
Facial skin glow will be measured at the left periocular area and the right and left cheeks using the Skin-Glossymeter® GL 200 probe.
Skin glow 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 at Weeks 3, 6, and 12. Higher values indicate greater skin glow.
|
Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
|
|
Change in Facial Skin Radiance
時間枠:Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
|
Facial skin radiance will be measured at the right and left periocular areas and the right and left cheeks using the Colorimeter FLEX CL440 probe.
Skin radiance 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 at Weeks 3, 6, and 12. Higher values indicate greater skin radiance.
|
Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
|
|
Change in Facial Stratum Corneum Hydration
時間枠:Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
|
Facial stratum corneum hydration will be measured at the right and left periocular areas and the right and left cheeks using the Corneometer® CM825 probe.
Hydration values will be expressed in arbitrary units (AU), with a measurement range of 0 to 130 AU.
Results will be reported as the mean change from baseline at Weeks 3, 6, and 12. Higher values indicate greater stratum corneum hydration.
|
Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
|
|
Change in Facial Skin pH
時間枠:Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
|
Facial skin pH will be measured at the right and left periocular areas and the right and left cheeks using the Skin-pH-Meter® PH905 probe.
Skin pH values will be reported on the pH scale, with a measurement range from 0 (acidic) to 12 (alkaline).
Results will be reported as the mean change from baseline at Weeks 3, 6, and 12.
|
Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
|
|
Mean Change From Baseline in Facial Wrinkle (SEw)
時間枠:Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
|
Facial wrinkle severity will be assessed using the Visioscan® VC 20 PLUS.
Results will be expressed as Surface Evaluation of Living Skin Wrinkle Parameter (SEw) values ranging from 0 to 500.
Higher values indicate greater wrinkle severity.
Results will be reported as the mean change from baseline at Weeks 3, 6, and 12.
|
Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
|
|
Mean Change From Baseline in Facial Skin Smoothness (SEsm)
時間枠:Baseline (Week 0) to Week 12 (assessments at Weeks 3, 6, and 12)
|
Facial skin smoothness will be assessed using the Visioscan® VC 20 PLUS.
Results will be expressed as Surface Evaluation of Living Skin Smoothness Parameter (SEsm) values ranging from 0 to 500.
Lower values indicate smoother skin and a better outcome.
Results will be reported as the mean change from baseline at Weeks 3, 6, and 12.
|
Baseline (Week 0) to Week 12 (assessments at Weeks 3, 6, and 12)
|
|
Mean Change From Baseline in Facial Skin Roughness (SEr)
時間枠:Baseline (Week 0) to Week 12 (assessments at Weeks 3, 6, and 12)
|
Facial skin roughness will be assessed using the Visioscan® VC 20 PLUS.
Results will be expressed as Surface Evaluation of Living Skin Roughness Parameter (SEr) values ranging from 0 to 500.
Higher values indicate greater skin roughness.
Results will be reported as the mean change from baseline at Weeks 3, 6, and 12.
|
Baseline (Week 0) to Week 12 (assessments at Weeks 3, 6, and 12)
|
|
Mean Change From Baseline in Facial Skin Scaliness (SEsc)
時間枠:Baseline (Week 0) to Week 12 (assessments at Weeks 3, 6, and 12)
|
Facial skin scaliness will be assessed using the Visioscan® VC 20 PLUS.
Results will be expressed as Surface Evaluation of Living Skin Scaliness Parameter (SEsc) values ranging from 0 to 500.
Higher values indicate greater skin scaliness.
Results will be reported as the mean change from baseline at Weeks 3, 6, and 12.
|
Baseline (Week 0) to Week 12 (assessments at Weeks 3, 6, and 12)
|
|
Change in Glogau Photodamage Scale Classification
時間枠:Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
|
The change in facial skin ageing severity assessed by investigator evaluation using the Glogau Photodamage Scale.
The Glogau Photodamage Scale ranges from Type I (no wrinkles) to Type IV (severe photoaging with advanced wrinkling) and provides a qualitative assessment of photodamage and wrinkle severity.
Results will be reported as the change from baseline in Glogau Photodamage Scale classification at Weeks 3, 6, and 12.
|
Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
|
|
Change From Baseline in Global Aesthetic Improvement Scale (GAIS) Score
時間枠:Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
|
Facial appearance will be self-assessed using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale ranging from 1 (Much Worse) to 5 (Very Much Improved).
Higher scores indicate greater perceived improvement in facial appearance.
Results will be reported as the change from baseline in GAIS score at Weeks 3, 6, and 12.
|
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
時間枠:Week 12
|
Participant satisfaction with the study product will be assessed at Week 12 using a 5-point Likert scale ranging from 1 (Very Dissatisfied) to 5 (Very Satisfied).
Higher scores indicate greater satisfaction with the study product.
Results will be reported as the participant satisfaction score at Week 12.
|
Week 12
|
|
Number of Participants With Adverse Events
時間枠:Baseline (week 0) to week 12
|
Adverse events (AEs) and serious adverse events (SAEs) reported from baseline through Week 12 will be recorded and summarized by treatment group.
The incidence, severity, and relationship to the study product will be assessed by the investigator.
The outcome will be reported as the number of participants experiencing at least one adverse event.
|
Baseline (week 0) to week 12
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- PJ-0188
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。