An interventional study of DERMIAL and Placebo in Healthy Adult Females, sponsored by Bioiberica. Recruiting at 1 site in Spain. Open to female participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Bioiberica · Not applicable, Interventional, and Treatment
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.
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.
Bioiberica is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hyaluronic acid matrix ingredien
Dietary Supplement: DERMIAL
Placebo
Other: Placebo
1 cap 60 mg/day
Placebo
Change in Facial Skin Glow
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.
Time frame: Baseline (week 0) to week 12 (primary analysis at week 12; assessments at weeks 3, 6 and 12)
Change in Skin Glow at Additional Facial Areas
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.
Time frame: Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
Change in Facial Skin Radiance
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.
Time frame: Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
Change in Facial Stratum Corneum Hydration
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.
Time frame: Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
Change in Facial Skin pH
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.
Time frame: Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
Mean Change From Baseline in Facial Wrinkle (SEw)
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.
Time frame: Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
Mean Change From Baseline in Facial Skin Smoothness (SEsm)
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.
Time frame: Baseline (Week 0) to Week 12 (assessments at Weeks 3, 6, and 12)
Mean Change From Baseline in Facial Skin Roughness (SEr)
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.
Time frame: Baseline (Week 0) to Week 12 (assessments at Weeks 3, 6, and 12)
Mean Change From Baseline in Facial Skin Scaliness (SEsc)
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.
Time frame: Baseline (Week 0) to Week 12 (assessments at Weeks 3, 6, and 12)
Change in Glogau Photodamage Scale Classification
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.
Time frame: Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
Change From Baseline in Global Aesthetic Improvement Scale (GAIS) Score
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.
Time frame: 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
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.
Time frame: Week 12
Number of Participants With Adverse Events
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.
Time frame: Baseline (week 0) to week 12
Plan to share: Undecided
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