Skin AgingNCT03460860
Astaxanthin (2 mg) + Lycopene (1.8 mg) + D-Alpha-Tocopherol (10 IU) For The Treatment Of Skin Aging
A study testing Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU) in people with Skin Aging and Wrinkles, run by United Laboratories at 1 site in Philippines.
Trial summary
The purpose of this study is to determine the clinical efficacy of a combination of Astaxanthin (2 mg), Lycopene (1.8 mg), and d-alpha-Tocopherol (10 IU) in terms of its skin anti-aging properties. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Wrinkles
- What is being tested?
- Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePhilippines
- Study dates
- 5 Mar 2018to 7 Feb 2019
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals age 30 to 60 years old
- Fitzpatrick Skin Type I-IV
- Crow's Feet Wrinkle Scale Class 1-2
- Subjects willing to provide written informed consent
Who cannot join
- Use of topical or oral anti-aging drug therapy 1 month prior to the study
- History of allergy to cosmetics and anti-aging drugs
- History of photosensitivity reactions
- Any current or past medical condition, including seizures and stroke
- History of pigmentation disorder such as but not limited to vitiligo and leukoderma
- Immunocompromised state
Show all 11Show fewer
- Pregnant or lactating (pregnancy kit will be used to check)
- Patients who have undergone laser, radiofrequency, peeling, and other procedural therapies for anti-aging in the month prior to the study.
- Patients with current inflammatory or infectious skin disease on the face, or history of such in the month prior to the study.
- Patients taking OCDs and other photosensitizing drugs (e.g. tetracycline).
- Not willing to provide informed consent
Trial locations and contacts
1 site in 1 country.
Philippines1 site
PDC Building, 1440 Taft Avenue
Manila, National Capital Region
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating The Safety And Efficacy Of An Oral Supplement Containing Astaxanthin (2 mg) + Lycopene (1.8 mg) + D-Alpha-Tocopherol (10 IU) For The Treatment Of Skin Aging
The purpose of this study is to determine the clinical efficacy of a combination of Astaxanthin (2 mg), Lycopene (1.8 mg), and d-alpha-Tocopherol (10 IU) in terms of its skin anti-aging properties. Specifically, the investigators aim to determine the increase in hydration levels of the skin, decrease in atypical skin pigmentation, and reduction of signs of photoaging, particularly facial fine lines.
- Conditions
- Skin Aging, Wrinkles
- Being tested
- Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)Dietary supplement
The intervention is to be taken once daily, for 12 weeks.
PlaceboDietary supplement
The intervention is to be taken once daily, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU) | Experimental | Not described Receives: Dietary Supplement: Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU) |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects within each treatment group with a significant decrease in skin wrinkling measured by a validated Crow's Feet Wrinkle scale.
The scale ratings are 0 for no wrinkles, 1 for very fine wrinkles, 2 for fine wrinkles, 3 for moderate wrinkles, and 4 for severe wrinkles.
Measured: 12 weeks
Secondary outcomes (2)
Proportion of subjects within each treatment group with a significant increase in skin hydration measured by a corneometer.
Measured: 12 weeks
Proportion of subjects within each treatment group with a significant decrease in pigmentation measured by a mexameter.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start5 Mar 2018
- Primary completion10 Oct 2018
- Study completion7 Feb 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460860
- Sponsor's protocol ID
- RD2017-06 (Anti-Aging Study)
- Status last verified
- Jun 2019
- First submitted
- 4 Mar 2018
- Last updated
- 26 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating The Safety And Efficacy Of An Oral Supplement Containing Astaxanthin (2 mg) + Lycopene (1.8 mg) + D-Alpha-Tocopherol (10 IU) For The Treatment Of Skin Aging
- ClinicalTrials.gov ID
- NCT03460860
- Acronym / sponsor ID
- RD2017-06 (Anti-Aging Study)
- Conditions
- Skin Aging, Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- United LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 9 Mar 2018 (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 purpose of this study is to determine the clinical efficacy of a combination of Astaxanthin (2 mg), Lycopene (1.8 mg), and d-alpha-Tocopherol (10 IU) in terms of its skin anti-aging properties. Specifically, the investigators aim to determine the increase in hydration levels of the skin, decrease in atypical skin pigmentation, and reduction of signs of photoaging, particularly facial fine lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU) | Experimental | Dietary Supplement: Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy individuals age 30 to 60 years old
- Fitzpatrick Skin Type I-IV
- Crow's Feet Wrinkle Scale Class 1-2
- Subjects willing to provide written informed consent
Key exclusion criteria (11 listed)
- Use of topical or oral anti-aging drug therapy 1 month prior to the study
- History of allergy to cosmetics and anti-aging drugs
- History of photosensitivity reactions
- Any current or past medical condition, including seizures and stroke
- History of pigmentation disorder such as but not limited to vitiligo and leukoderma
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 |
|---|---|---|
| Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)The intervention is to be taken once daily, for 12 weeks. | Dietary supplement | Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU) |
| PlaceboThe intervention is to be taken once daily, for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Proportion of subjects within each treatment group with a significant decrease in skin wrinkling measured by a validated Crow's Feet Wrinkle scale.
Time frame: 12 weeks
The scale ratings are 0 for no wrinkles, 1 for very fine wrinkles, 2 for fine wrinkles, 3 for moderate wrinkles, and 4 for severe wrinkles.
2 secondary outcomes
Proportion of subjects within each treatment group with a significant increase in skin hydration measured by a corneometer.
Time frame: 12 weeks
Proportion of subjects within each treatment group with a significant decrease in pigmentation measured by a mexameter.
Time frame: 12 weeks
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 26 Jun 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU) in people with Skin Aging and Wrinkles, run by United Laboratories at 1 site in Philippines.
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 11 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 26 Jun 2019. 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 Philippines. 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?
Proportion of subjects within each treatment group with a significant decrease in skin wrinkling measured by a validated Crow's Feet Wrinkle scale. (time frame: 12 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 26 Jun 2019.