Skin HealthPhase 4NCT06971029
IMPACT OF SUPPLEMENTATION WITH LOW MOLECULAR WEIGHT HYDROLYZED COLLAGEN AND VERISOL ON THE EXPRESSION OF LINES, SKIN QUALITY, AND LEVELS OF KLOTHO, VEGF, AND TGF-BETA IN THE EYE REGION
A Phase 4 study testing Supplementation with Verisol®, Supplementation with Peptech® 2.5G and Supplementation with Peptech® 10.0G in people with Skin Health and Collagen Supplementation, run by Federal University of São Paulo.
Trial summary
Skin is the largest organ of the human body and performs various vital functions, including protection against external agents, regulation of body temperature, and sensory perception. As we age, our skin undergoes a series of changes that can be noticeable both visually and physically. Read more about this study
- Who is it for?
- Ages 35 to 58 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Health, Collagen Supplementation, Growth Factors
- What is being tested?
- Supplementation with Verisol®, Supplementation with Peptech® 2.5G and Supplementation with Peptech® 10.0G
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 9 Jun 2025to Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 58 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- "Inclusion criteria require that volunteers be between 35 and 58 years old, have been sedentary for at least one year, and, after reading and understanding all stages of the study, agree to and sign the informed consent form (ICF).
Who cannot join
- "Exclusion criteria include undergoing facial aesthetic procedures involving hyaluronic acid or botulinum toxin, being an active or passive smoker within the past 3 years, using protein- or amino acid-based supplements within the past 6 months, or using cosmetics with skin-repairing properties in the orbicularis oculi region.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Luis Vicente Franco de Oliveira Coordinator of the Stricto Sensu Graduate Program in Human Mov contact
About this study
Official title: Effects Of Supplementation With New Technology for Obtaining Low Molecular Weight Hydrolyzed Collagen Vs. Verisol Collagen on Expression Lines, Skin Quality in the Orbicularis Oculi Region, And Serum Levels of Klotho, VEGF, and TGF-Beta
Skin is the largest organ of the human body and performs various vital functions, including protection against external agents, regulation of body temperature, and sensory perception. As we age, our skin undergoes a series of changes that can be noticeable both visually and physically. One of the most evident changes is the appearance of wrinkles and fine lines, resulting from decreased skin elasticity and reduced production of collagen and elastin. Nutrition plays a key role in skin health, influencing its structure, function, and ability to defend against damage and diseases. However, it is unknown to what extent supplementation with different types of collagens can attenuate these effects in middle-aged women. Therefore, the present study aims to recruit 150 middle-aged women (35-58 years old) who will be randomized into three groups, Verisol Collagen 2.5 g/day, Peptech Collagen 2.5 g/day, and Peptech Collagen 10 g/day, 7 days a week, for 3 months. Skin hydration, oiliness, and flexibility, as well as the number and depth of expression lines, will be evaluated, along with plasma levels of Klotho, VEGF, and TGF-beta. Data will be analyzed, and graphs constructed using GraphPad Prism 5.0 software (California, USA). The normality distribution of the data will be assessed by the Kolmogorov-Smirnov test. Data with parametric distribution will be subjected to paired Student's t-test for intragroup comparison, and unpaired t-test will be used for comparison between groups. Significance levels will be considered statistically different for p<0.05.
- Conditions
- Skin Health, Collagen Supplementation, Growth Factors
- Being tested
- Supplementation with Verisol®, Supplementation with Peptech® 2.5G, Supplementation with Peptech® 10.0G, Control group
- Keywords
- Skin health, collagen supplementation, growth factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation with Verisol®Dietary supplement
Supplementation with Verisol® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months.
Supplementation with Peptech® 2.5GDietary supplement
Supplementation with Peptech® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months.
Supplementation with Peptech® 10.0GDietary supplement
Supplementation with Peptech® collagen will be administered at a dose of 10.0 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months.
Control groupDiagnostic test
The control group will not receive supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Verisol Collagen 2.5 g/day | Experimental | Supplementation with Verisol® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months. Receives: Dietary Supplement: Supplementation with Verisol® |
| Peptech Collagen 2.5 g/day (GCP 2.5) | Experimental | Supplementation with Peptech® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months. Receives: Dietary Supplement: Supplementation with Peptech® 2.5G |
| eptech Collagen 10 g/day (GCP 10) | Experimental | Supplementation with Peptech® collagen will be administered at a dose of 10.0 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months. Receives: Dietary Supplement: Supplementation with Peptech® 10.0G |
| Group Control | Other | he control group will undergo the tests but will not receive supplementation. Receives: Diagnostic Test: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of Klotho, VEGF, and TGF-beta
Measured: Three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start9 Jun 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin HealthStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The 150 volunteers will be randomized into three groups (n = 50/group): Verisol Collagen 2.5 g/day (GCV), Peptech Collagen 2.5 g/day (GCP 2.5), and Peptech Collagen 10 g/day (GCP 10).
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodolfo de Paula Vieira, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971029
- Sponsor's protocol ID
- 7.233.377
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Proksch E, Brandner JM, Jensen JM. The skin: an indispensable barrier. Exp Dermatol. 2008 Dec;17(12):1063-72. doi: 10.1111/j.1600-0625.2008.00786.x.
PubMed 19043850Paula-Vieira RHR, Dias SR, Silva-Reis A, Moura-Maia MS, Ramos-Gomes NV, Jesus-Silva K, Oliveira-Leal YR, Castro-Pimentel LT, Carvalho WSF, Melo F, Martins JLR, Bachi ALL, Vieira RP. Immune-Modulatory Effects of Bioactive Collagen Peptides Improve Skin Health in Middle-Aged Women. Dermatol Ther (Heidelb). 2026 Feb;16(2):1385-1397. doi: 10.1007/s13555-026-01654-9. Epub 2026 Jan 27.
PubMed 41588262
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Supplementation With New Technology for Obtaining Low Molecular Weight Hydrolyzed Collagen Vs. Verisol Collagen on Expression Lines, Skin Quality in the Orbicularis Oculi Region, And Serum Levels of Klotho, VEGF, and TGF-Beta
- ClinicalTrials.gov ID
- NCT06971029
- Acronym / sponsor ID
- 7.233.377
- Conditions
- Skin Health, Collagen Supplementation, Growth Factors
- Keywords
- Skin health, collagen supplementation, growth factors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 9 Jun 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 May 2025 (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.
Skin is the largest organ of the human body and performs various vital functions, including protection against external agents, regulation of body temperature, and sensory perception. As we age, our skin undergoes a series of changes that can be noticeable both visually and physically. One of the most evident changes is the appearance of wrinkles and fine lines, resulting from decreased skin elasticity and reduced production of collagen and elastin. Nutrition plays a key role in skin health, influencing its structure, function, and ability to defend against damage and diseases. However, it is unknown to what extent supplementation with different types of collagens can attenuate these effects in middle-aged women. Therefore, the present study aims to recruit 150 middle-aged women (35-58 years old) who will be randomized into three groups, Verisol Collagen 2.5 g/day, Peptech Collagen 2.5 g/day, and Peptech Collagen 10 g/day, 7 days a week, for 3 months. Skin hydration, oiliness, and flexibility, as well as the number and depth of expression lines, will be evaluated, along with plasma levels of Klotho, VEGF, and TGF-beta. Data will be analyzed, and graphs constructed using GraphPad Prism 5.0 software (California, USA). The normality distribution of the data will be assessed by the Kolmogorov-Smirnov test. Data with parametric distribution will be subjected to paired Student's t-test for intragroup comparison, and unpaired t-test will be used for comparison between groups. Significance levels will be considered statistically different for p<0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The 150 volunteers will be randomized into three groups (n = 50/group): Verisol Collagen 2.5 g/day (GCV), Peptech Collagen 2.5 g/day (GCP 2.5), and Peptech Collagen 10 g/day (GCP 10).
| Arm | Type | Receives |
|---|---|---|
| Verisol Collagen 2.5 g/day | Experimental | Dietary Supplement: Supplementation with Verisol®Supplementation with Verisol® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months. |
| Peptech Collagen 2.5 g/day (GCP 2.5) | Experimental | Dietary Supplement: Supplementation with Peptech® 2.5GSupplementation with Peptech® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months. |
| eptech Collagen 10 g/day (GCP 10) | Experimental | Dietary Supplement: Supplementation with Peptech® 10.0GSupplementation with Peptech® collagen will be administered at a dose of 10.0 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months. |
| Group Control | Other | Diagnostic Test: Control grouphe control group will undergo the tests but will not receive supplementation. |
Who may qualify
- Ages
- 35 to 58 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- "Inclusion criteria require that volunteers be between 35 and 58 years old, have been sedentary for at least one year, and, after reading and understanding all stages of the study, agree to and sign the informed consent form (ICF).
Key exclusion criteria (1 listed)
- "Exclusion criteria include undergoing facial aesthetic procedures involving hyaluronic acid or botulinum toxin, being an active or passive smoker within the past 3 years, using protein- or amino acid-based supplements within the past 6 months, or using cosmetics with skin-repairing properties in the orbicularis oculi region.
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 |
|---|---|---|
| Supplementation with Verisol®Supplementation with Verisol® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months. | Dietary supplement | Verisol Collagen 2.5 g/day |
| Supplementation with Peptech® 2.5GSupplementation with Peptech® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months. | Dietary supplement | Peptech Collagen 2.5 g/day (GCP 2.5) |
| Supplementation with Peptech® 10.0GSupplementation with Peptech® collagen will be administered at a dose of 10.0 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months. | Dietary supplement | eptech Collagen 10 g/day (GCP 10) |
| Control groupThe control group will not receive supplementation. | Diagnostic test | Group Control |
Primary outcome
Plasma levels of Klotho, VEGF, and TGF-beta
Time frame: Three months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Results publication: PubMed 19043850Proksch E, Brandner JM, Jensen JM. The skin: an indispensable barrier. Exp Dermatol. 2008 Dec;17(12):1063-72. doi: 10.1111/j.1600-0625.2008.00786.x.
- Derived from this study: PubMed 41588262Paula-Vieira RHR, Dias SR, Silva-Reis A, Moura-Maia MS, Ramos-Gomes NV, Jesus-Silva K, Oliveira-Leal YR, Castro-Pimentel LT, Carvalho WSF, Melo F, Martins JLR, Bachi ALL, Vieira RP. Immune-Modulatory Effects of Bioactive Collagen Peptides Improve Skin Health in Middle-Aged Women. Dermatol Ther (Heidelb). 2026 Feb;16(2):1385-1397. doi: 10.1007/s13555-026-01654-9. Epub 2026 Jan 27.
- 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.
Luis Vicente Franco de Oliveira Coordinator of the Stricto Sensu Graduate Program in Human Mov contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Supplementation with Verisol®, Supplementation with Peptech® 2.5G and Supplementation with Peptech® 10.0G in people with Skin Health and Collagen Supplementation, run by Federal University of São Paulo.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Vicente Franco de Oliveira Coordinator of the Stricto Sensu Graduate Program in Human Mov ((62)3310-6736, luis.oliveira@unievangelica.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma levels of Klotho, VEGF, and TGF-beta (time frame: Three months.). 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 NCT06971029, which also lists 2 linked publications.
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 14 May 2025.