Skin AgingDermiAgeNCT05813054
Clinical Study to Evaluate the Anti-aging Efficacy of Dermial®
A study testing HA matrix ingredient in people with Skin Aging, run by Bioiberica at 1 site in Spain.
Trial summary
Oral supplement with an HA matrix ingredient composed of HA (60-75%), sulfated GAGs (≥10%), including DS and CS, and collagen (≥ 5%) to evaluate the hydration of the stratum corneum of facial skin in healthy women showing natural signs of age-related aging versus placebo Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- HA matrix ingredient
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy women between 35 and 65 years of age (inclusive), showing signs of physiological facial skin aging.
- Women willing not to use any firming product, skin lightening, or any other topical or systemic medication known to affect skin aging or dyschromia during the study period.
- Be informed of the nature of the study and give their IC in writing.
- Women willing not to become pregnant during the course of the study, using contraceptive methods considered highly effective.
Who cannot join
- Women with allergies to the ingredients in the investigational product.
- Women who have used a dietary or nutricosmetic supplement containing HA, or who have undergone Botox or HA infiltrations, in the last 6 months prior to signing the IC.
- Women who have undergone:
- Superficial or medium-deep chemical peels or dermabrasion within the 6 weeks prior to signing the IC or inclusion document.
- Deep facial chemical peel, non-ablative laser or fractional laser resurfacing in the 12 months prior to signing the IC or inclusion document.
- Facial plastic surgery or a laser ablative procedure for photoaging in the 12 months prior to signing the IC or inclusion document.
Show all 13Show fewer
- Suspected uncontrolled disease, such as diabetes mellitus (DM), arterial hypertension (HT), hyperthyroidism or hypothyroidism, renal failure or liver failure.
- Women who have received a PRP (Platelet Rich Plasma) injection as a treatment for aesthetic purposes, in the 3 months prior to inclusion by signing the IC.
- Women who do not wish, for whatever reason, to take the supplements in the study.
- Known pregnancy or lactation.
- Presence of inflammatory skin disease such as psoriasis, atopic dermatitis, rosacea, acne or hidradenitis suppurativa.
- Presence of active malignant pathologies or premalignant skin lesions such as actinic keratoses.
- Psychiatric disorder that is not managed or any other circumstance or pathology that prevents the participant from understanding and/or complying with the study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Anti-aging Efficacy of Dermial®
Oral supplement with an HA matrix ingredient composed of HA (60-75%), sulfated GAGs (≥10%), including DS and CS, and collagen (≥ 5%) to evaluate the hydration of the stratum corneum of facial skin in healthy women showing natural signs of age-related aging versus placebo
Read the detailed description
This study includes 60 healthy volunteers in which will be evaluated if the oral supplement with Dermial [composed of HA (60-75%), sulfated GAGs (≥10%), including DS and CS, and collagen (≥ 5%)] is able to obtain differences versus placebo in healthy women showing natural signs of age-related aging versus placebo . It is a single-center, double-blind, randomized, placebo-controlled clinical study with proportion 1:1 between treatments.
- Conditions
- Skin Aging
- Being tested
- HA matrix ingredient, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA matrix ingredientDietary supplement
1 capsule/day
PlaceboDietary supplement
1 capsule/day
| Study group | Role | What they receive |
|---|---|---|
| HA matrix ingredient | Experimental | 1 cap/day Receives: Dietary Supplement: HA matrix ingredient |
| Placebo | Placebo comparator | 1 cap/day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Moisture
The changes in the hydration of the facial stratum corneum using the Corneometer® CM825 measuring device, range: 0-130 arbitrary units
Measured: Day 0, 12 week
Secondary outcomes (15)
Skin Moisture
Evaluate changes in the hydration of the facial stratum corneum from baseline to 6 and 12 week by Corneometer® CM825 measuring device, range: 0-130 arbitrary units
Measured: Day 0, 6 week, 12 week
Skin elasticity
The changes of skin elasticity by Cutometer ® Dual MPA 580 probe, range: 0-100%.
Measured: Day 0, 6 week, 12 week
Skin hardness
The changes of Skin hardness by PCE-DDO 10 Durometer probe, range: 0-100 Shore O.
Measured: Day 0, 6 week, 12 week
Skin Barrier
The changes of skin barrier in terms of TEWL (Trans Epidermal Water Loss) by Tewameter® TM300 probe, range: 0-80 (g*m-2*h-1).
Measured: Day 0, 6 week, 12 week
Skin pH
The changes of skin pH by Skin-pH-Meter®PH905 probe, range: pH0 (acidic) - pH12 (alkaline).
Measured: Day 0, 6 week, 12 week
Skin temperature
The changes of the skin temperature by Skin-Thermometer ST500 probe, range: 15°C-40°C.
Measured: Day 0, 6 week, 12 week
Antioxidant capacity of the skin
The total antioxidant capacity will be measured in microcoulombs, using conductive hydrogel strips designed for the direct measurement of antioxidant capacity using eBQC®, range: 0-20 microcoulombs.
Measured: Day 0, 6 week, 12 week
Erythema and skin melanin index
The erythema and melanin index will be measured in arbitrary units using the Mexameter® MX18 probe, range: 50-600 arbitrary units .
Measured: Day 0, 6 week, 12 week
Skin stiffness/deformability
The changes of the stiffness/deformability by Indentometer IDM 800 probe, range: 0.00-3.00 millimeters.
Measured: Day 0, 6 week, 12 week
Skin friction
The changes of the skin friction by Frictiometer FR-700, range: 0-30 arbitrary units .
Measured: Day 0, 6 week, 12 week
Skin radiance
The changes of the skin radiance by Skin-Glossymeter GL 200 probe, range: 0-100 arbitrary units.
Measured: Day 0, 6 week, 12 week
Facial Wrinkles and Fine lines of Crow's feet
Assessment of Reduction in Facial Wrinkles and Fine lines of Crow's feet area by VisioScan. It consists of a UV light camera and measures the skin surface profiles. (0-500 Rz)
Measured: Day 0, 6 week, 12 week
Glogau Photodamage Scale
The change between the photodamage grade by dermatologist physical examination of treated area. The Glogau Photodamage Scale has a score from 1-4 (Type I: No wrinkles, Type II: Wrinkles in motion, Type III: Wrinkles at rest, Type IV: Only wrinkles), this scale represents a qualitative assessment to measure the severity of photodamage and wrinkles.
Measured: Day 0, 6 week, 12 week
Satisfaction assessed
Level of satisfaction with the sensation of skin hydration, texture, luminosity and smoothness using a self-administered 5-point Likert scale of intensity ( 1_Very dissatisfied; 2_Dissatisfied; 3_Neither satisfied nor dissatisfied; 4_Satisfied; 5_Very) satisfied
Measured: Day 0, 12 week
Safety assessment
Adverse events
Measured: Day 0 to 12 week (anytime)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start1 Oct 2022
- Primary completion15 Mar 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioiberica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salvador Arias, Principal investigator, University Hospital Virgen de las Nieves
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813054
- Sponsor's protocol ID
- PJ-00106
- Acronym
- DermiAge
- Status last verified
- Mar 2023
- First submitted
- 17 Feb 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montero-Vilchez T, Galvez-Martin P, Sanabria-de la Torre R, Cuenca-Barrales C, Molina-Leyva A, Martinez-Puig D, Velasco-Alvarez J, Arias-Santiago S. Oral Supplementation with a New Hyaluronic Acid Matrix Ingredient Improves Skin Brightness, Hydration, Smoothness, and Roughness: Results from a Randomized, Double-Blinded, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2025 Aug;15(8):2099-2116. doi: 10.1007/s13555-025-01447-6. Epub 2025 Jun 11.
PubMed 40498387
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Anti-aging Efficacy of Dermial®
- ClinicalTrials.gov ID
- NCT05813054
- Acronym / sponsor ID
- DermiAge / PJ-00106
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BioibericaIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral supplement with an HA matrix ingredient composed of HA (60-75%), sulfated GAGs (≥10%), including DS and CS, and collagen (≥ 5%) to evaluate the hydration of the stratum corneum of facial skin in healthy women showing natural signs of age-related aging versus placebo
Detailed description
This study includes 60 healthy volunteers in which will be evaluated if the oral supplement with Dermial [composed of HA (60-75%), sulfated GAGs (≥10%), including DS and CS, and collagen (≥ 5%)] is able to obtain differences versus placebo in healthy women showing natural signs of age-related aging versus placebo . It is a single-center, double-blind, randomized, placebo-controlled clinical study with proportion 1:1 between treatments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA matrix ingredient | Experimental | Dietary Supplement: HA matrix ingredient1 cap/day |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 cap/day |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy women between 35 and 65 years of age (inclusive), showing signs of physiological facial skin aging.
- Women willing not to use any firming product, skin lightening, or any other topical or systemic medication known to affect skin aging or dyschromia during the study period.
- Be informed of the nature of the study and give their IC in writing.
- Women willing not to become pregnant during the course of the study, using contraceptive methods considered highly effective.
Key exclusion criteria (13 listed)
- Women with allergies to the ingredients in the investigational product.
- Women who have used a dietary or nutricosmetic supplement containing HA, or who have undergone Botox or HA infiltrations, in the last 6 months prior to signing the IC.
- Women who have undergone:
- Suspected uncontrolled disease, such as diabetes mellitus (DM), arterial hypertension (HT), hyperthyroidism or hypothyroidism, renal failure or liver failure.
- Women who have received a PRP (Platelet Rich Plasma) injection as a treatment for aesthetic purposes, in the 3 months prior to inclusion by signing the IC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HA matrix ingredient1 capsule/day | Dietary supplement | HA matrix ingredient |
| Placebo1 capsule/day | Dietary supplement | Placebo |
Primary outcome
Skin Moisture
Time frame: Day 0, 12 week
The changes in the hydration of the facial stratum corneum using the Corneometer® CM825 measuring device, range: 0-130 arbitrary units
15 secondary outcomes
Skin Moisture
Time frame: Day 0, 6 week, 12 week
Skin elasticity
Time frame: Day 0, 6 week, 12 week
Skin hardness
Time frame: Day 0, 6 week, 12 week
Skin Barrier
Time frame: Day 0, 6 week, 12 week
Skin pH
Time frame: Day 0, 6 week, 12 week
Skin temperature
Time frame: Day 0, 6 week, 12 week
Antioxidant capacity of the skin
Time frame: Day 0, 6 week, 12 week
Erythema and skin melanin index
Time frame: Day 0, 6 week, 12 week
Skin stiffness/deformability
Time frame: Day 0, 6 week, 12 week
Skin friction
Time frame: Day 0, 6 week, 12 week
Skin radiance
Time frame: Day 0, 6 week, 12 week
Facial Wrinkles and Fine lines of Crow's feet
Time frame: Day 0, 6 week, 12 week
Glogau Photodamage Scale
Time frame: Day 0, 6 week, 12 week
Satisfaction assessed
Time frame: Day 0, 12 week
Safety assessment
Time frame: Day 0 to 12 week (anytime)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 40498387Montero-Vilchez T, Galvez-Martin P, Sanabria-de la Torre R, Cuenca-Barrales C, Molina-Leyva A, Martinez-Puig D, Velasco-Alvarez J, Arias-Santiago S. Oral Supplementation with a New Hyaluronic Acid Matrix Ingredient Improves Skin Brightness, Hydration, Smoothness, and Roughness: Results from a Randomized, Double-Blinded, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2025 Aug;15(8):2099-2116. doi: 10.1007/s13555-025-01447-6. Epub 2025 Jun 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvador Arias principal investigator
University Hospital Virgen de las Nieves
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HA matrix ingredient in people with Skin Aging, run by Bioiberica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Moisture (time frame: Day 0, 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05813054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.