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Clinical Study to Evaluate the Anti-aging Efficacy and Skin Radiance-enhancing Effect of Dermial®. (Dermiglow)

17 сентября 2026 г. обновлено: Bioiberica

Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Anti-aging Efficacy and Skin Radiance-enhancing Effect of Dermial®.

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.

Обзор исследования

Статус

Рекрутинг

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

146

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Patricia Gálvez Martín, Doctor
  • Номер телефона: +34 93 765 03 90
  • Электронная почта: pgalvez@bioiberica.com

Места учебы

    • Madrid
      • Madrid, Madrid, Испания, 28001
        • Рекрутинг
        • Institute of Advanced Medicine and Dermatology (IMDA)
        • Контакт:
          • Almudena Nuño, Doctor
          • Номер телефона: +34 91 632 56 59
          • Электронная почта: almudena@imda.es

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Да

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: DERMIAL
Hyaluronic acid matrix ingredien
1 cap 60 mg/day
Плацебо Компаратор: PLACEBO
Placebo
Плацебо

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Facial Skin Glow
Временное ограничение: 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)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Skin Glow at Additional Facial Areas
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

5 августа 2026 г.

Первичное завершение (Оцененный)

31 марта 2028 г.

Завершение исследования (Оцененный)

31 марта 2028 г.

Даты регистрации исследования

Первый отправленный

30 июля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

24 августа 2026 г.

Первый опубликованный (Действительный)

27 августа 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

18 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

17 сентября 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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