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

September 17, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28001
        • Recruiting
        • Institute of Advanced Medicine and Dermatology (IMDA)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DERMIAL
Hyaluronic acid matrix ingredien
Dietary supplement: DERMIAL
1 cap 60 mg/day
Placebo Comparator: PLACEBO
Placebo
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Facial Skin Glow
Time Frame: 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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Skin Glow at Additional Facial Areas
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bioiberica

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IMDA - Instituto de Medicina y Dermatología Avanzada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PJ-0188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings