Skin AgingNCT07740824
A Double-Blind, Randomized, Double-Dummy, Active and Placebo-Controlled Clinical Study to Assess the Effect of an Oral Skin Supplement on Skin Health in Healthy Adults
A study testing Active SoftGel Supplement and Active Comparator Powder in people with Skin Aging, run by Amazentis SA at 1 site in India.
Trial summary
The aim of this study is to investigate the impact of a two skin from within nutritional supplement(s) compared to placebo on skin aging biomarker changes. 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?
- Active SoftGel Supplement and Active Comparator Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 26 Aug 2026to 30 Sep 2027
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female trial participants in the age group of 35 -65 years, both ages inclusive.
- Trial participants in good general health, as determined by the Investigator based on medical history, physical examination, vital signs, and clinical laboratory evaluations (CBC, LFT, and RFT).
- Trial participants presenting with visible signs of facial skin aging, as assessed by the Investigator.
- Trial participants willing to consume the assigned study products daily for 8 weeks in accordance with the study protocol.
- Trial participants must be willing to undergo two minimally invasive skin biopsies collected from the upper arms.
- Trial participants must be willing to provide blood samples for plasma collection and laboratory Investigations.
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- Trial participants willing to refrain from initiating any new skin care products, oral supplements, or anti-aging treatments during the study.
- Trial participants willing to maintain their permitted and restricted skincare, diet, and lifestyle habits throughout the study.
- Trial participants free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face and upper arms as determined by the dermatologist.
- Trial participants who agree not to have direct and excessive sun exposure (not more than half an hour daily and during that time use of umbrella to cover face and upper arms).
- Trial participants willing to refrain from bleaching or any other procedures including facial etc. on face during the study period.
- Trial participants willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
- Trial participants willing to abide by and comply with study protocol.
Who cannot join
- Trial participants with known allergy, hypersensitivity, or intolerance to the study products or any of their ingredients, which, in the opinion of the Investigator, may impact participant safety, skin condition, or study outcomes.
- Trial participants with clinical non-significant laboratory values or clinically significant findings in CBC, LFT, or RFT that, in the opinion of the Investigator, may affect participant safety or study participation.
- Trial participants with a history or presence of clinically significant systemic diseases, including cardiovascular, immunological, vascular, hepatic, gallbladder, renal, or other uncontrolled medical disorders that, in the opinion of the Investigator, may interfere with study participation or study assessments.
- Trial participants with active dermatological conditions on the face, including eczema, psoriasis, rosacea, acne, dermatitis, infections, wounds, sunburn, scars, or other skin disorders that may interfere with study assessments.
- Trial participants who have used anti-aging treatments or procedures, including retinoids, isotretinoin, topical, systemic, injectable, or device-based therapies, within 3 months prior to screening.
- Trial participants currently taking any medication that, in the opinion of the Investigator, may affect study results or interfere with study participation.
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- Trial participants who have undergone facial cosmetic procedures or aesthetic treatments, including chemical peels, laser treatments, dermabrasion, microneedling, botulinum toxin injections, dermal fillers, or similar procedures within 3 months prior to screening.
- Trial participants currently using or having used within 1 month prior to screening oral supplements or medications known to influence skin appearance or aging (e.g., collagen supplements, biotin, antioxidant supplements, or investigational products).
- Trial participants with a history of keloid formation, hypertrophic scarring, poor wound healing, bleeding disorders, or active skin infection, inflammation, wounds, or other abnormal skin conditions at or near the planned biopsy site.
- Trial participants with a known bleeding disorder or current use of anticoagulant/antiplatelet medications that may interfere with blood collection.
- Trial participants who have participated in another similar clinical trial within 3 months prior to screening.
- Female trial participants who are pregnant, breastfeeding, or planning pregnancy during the study period.
- Trial participants with a history of smoking, current smoking, use of smokeless tobacco products, or a history of or ongoing alcohol or recreational drug abuse.
- Trial participants who are employees of the Sponsor, Contract Research Organization (CRO), or study site directly involved in the conduct of the study.
- Trial participants judged by the Investigator to be unsuitable for participation for any reason that may compromise participant safety, protocol compliance, or study integrity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
MS Clinical Research Pvt. Ltd
Bangalore, Karnataka, 560008
Dr Mukta Sachdev, +91-80-40917253, mukta.sachdev@msclinical.com
About this study
The aim of this study is to investigate the impact of a two skin from within nutritional supplement(s) compared to placebo on skin aging biomarker changes.
- Conditions
- Skin Aging
- Being tested
- Placebo SoftGel, Active SoftGel Supplement, Active Comparator Powder, Placebo Powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo SoftGelDietary supplement
The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products
Active SoftGel SupplementDietary supplement
The food supplement active supplement (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products
Active Comparator PowderDietary supplement
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water. The food supplement placebo (2 soft gels) will also be consumed once per day with a large glass of water to double-mask the trial.
Placebo PowderDietary supplement
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water.
| Study group | Role | What they receive |
|---|---|---|
| Food supplement placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo SoftGel; Dietary Supplement: Placebo Powder |
| Food supplement Active | Active comparator | Not described Receives: Dietary Supplement: Active SoftGel Supplement; Dietary Supplement: Placebo Powder |
| Food supplement Comparator | Sham comparator | Not described Receives: Dietary Supplement: Placebo SoftGel; Dietary Supplement: Active Comparator Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin aging hallmarks
Change from baseline in skin hallmarks of aging (assessed on 2X2mm punch skin biopsies) after 8 weeks in a subpanel of participants
Measured: 8 weeks
Secondary outcomes (3)
Dermatological Assessments of Skin Health (Photo-grading using VISIA imaging)
To evaluate and compare the efficacy of the test product with baseline and an active comparator in improving facial skin health as assessed with photoimaging (VISIA)
Measured: 8 weeks
changes in circulating levels of Urolithin A in plasma samples of participants by bioanalytical assessments.
Measured: 8 weeks
Incidence of adverse events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start26 Aug 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MS Clinical Research Pvt. Ltd
- Responsible party
- Sponsor
- Investigators
- Dr. Mukta Sachdev, MD, Study director, MS Clinical Research Pvt. Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740824
- Sponsor's protocol ID
- SKIN/TLSS/2026-01
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Double-Dummy, Active and Placebo-Controlled Clinical Study to Assess the Effect of an Oral Skin Supplement on Skin Health in Healthy Adults
- ClinicalTrials.gov ID
- NCT07740824
- Acronym / sponsor ID
- SKIN/TLSS/2026-01
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- MS Clinical Research Pvt. Ltd
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 3 Aug 2026 (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.
The aim of this study is to investigate the impact of a two skin from within nutritional supplement(s) compared to placebo on skin aging biomarker changes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Food supplement placebo | Placebo comparator | Dietary Supplement: Placebo SoftGel, Dietary Supplement: Placebo Powder |
| Food supplement Active | Active comparator | Dietary Supplement: Active SoftGel Supplement, Dietary Supplement: Placebo Powder |
| Food supplement Comparator | Sham comparator | Dietary Supplement: Placebo SoftGel, Dietary Supplement: Active Comparator Powder |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male and female trial participants in the age group of 35 -65 years, both ages inclusive.
- Trial participants in good general health, as determined by the Investigator based on medical history, physical examination, vital signs, and clinical laboratory evaluations (CBC, LFT, and RFT).
- Trial participants presenting with visible signs of facial skin aging, as assessed by the Investigator.
- Trial participants willing to consume the assigned study products daily for 8 weeks in accordance with the study protocol.
- Trial participants must be willing to undergo two minimally invasive skin biopsies collected from the upper arms.
Key exclusion criteria (15 listed)
- Trial participants with known allergy, hypersensitivity, or intolerance to the study products or any of their ingredients, which, in the opinion of the Investigator, may impact participant safety, skin condition, or study outcomes.
- Trial participants with clinical non-significant laboratory values or clinically significant findings in CBC, LFT, or RFT that, in the opinion of the Investigator, may affect participant safety or study participation.
- Trial participants with a history or presence of clinically significant systemic diseases, including cardiovascular, immunological, vascular, hepatic, gallbladder, renal, or other uncontrolled medical disorders that, in the opinion of the Investigator, may interfere with study participation or study assessments.
- Trial participants with active dermatological conditions on the face, including eczema, psoriasis, rosacea, acne, dermatitis, infections, wounds, sunburn, scars, or other skin disorders that may interfere with study assessments.
- Trial participants who have used anti-aging treatments or procedures, including retinoids, isotretinoin, topical, systemic, injectable, or device-based therapies, within 3 months prior to screening.
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 |
|---|---|---|
| Placebo SoftGelThe food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products | Dietary supplement | Food supplement Comparator, Food supplement placebo |
| Active SoftGel SupplementThe food supplement active supplement (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products | Dietary supplement | Food supplement Active |
| Active Comparator PowderActive supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water. The food supplement placebo (2 soft gels) will also be consumed once per day with a large glass of water to double-mask the trial. | Dietary supplement | Food supplement Comparator |
| Placebo PowderActive supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water. | Dietary supplement | Food supplement Active, Food supplement placebo |
Primary outcome
Skin aging hallmarks
Time frame: 8 weeks
Change from baseline in skin hallmarks of aging (assessed on 2X2mm punch skin biopsies) after 8 weeks in a subpanel of participants
3 secondary outcomes
Dermatological Assessments of Skin Health (Photo-grading using VISIA imaging)
Time frame: 8 weeks
changes in circulating levels of Urolithin A in plasma samples of participants by bioanalytical assessments.
Time frame: 8 weeks
Incidence of adverse events
Time frame: 8 weeks
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 22 Sep 2026.
- 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.
Dr. Mukta Sachdev, MD study director
MS Clinical Research Pvt. Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active SoftGel Supplement and Active Comparator Powder in people with Skin Aging, run by Amazentis SA at 1 site in India.
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 13 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. 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 India. 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?
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 Anurag Singh, MD PhD (+41215221274, asingh@timeline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin aging hallmarks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.