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

17 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

146

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Spanje
    • Madrid
      • Madrid, Madrid, Spanje, 28001
        • Werving
        • Institute of Advanced Medicine and Dermatology (IMDA)
        • Contact:
          • Almudena Nuño, Doctor
          • Telefoonnummer: +34 91 632 56 59
          • E-mail: almudena@imda.es

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: DERMIAL
Hyaluronic acid matrix ingredien
Voedingssupplement: DERMIAL
1 cap 60 mg/day
Placebo-vergelijker: PLACEBO
Placebo
Ander: Placebo
Placebo

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Facial Skin Glow
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Skin Glow at Additional Facial Areas
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Bioiberica

Medewerkers

IMDA - Instituto de Medicina y Dermatología Avanzada

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 augustus 2026

Primaire voltooiing (Geschat)

31 maart 2028

Studie voltooiing (Geschat)

31 maart 2028

Studieregistratiedata

Eerst ingediend

30 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 augustus 2026

Eerst geplaatst (Werkelijk)

27 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 september 2026

Laatste update ingediend die voldeed aan QC-criteria

17 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • PJ-0188

Plan Individuele Deelnemersgegevens (IPD)

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ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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