ClinicalTrials.gg
CompletedNCT03460860Updated Jun 26, 2019

Astaxanthin (2 mg) + Lycopene (1.8 mg) + D-Alpha-Tocopherol (10 IU) For The Treatment Of Skin Aging

An interventional study of Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU) and Placebo in Skin Aging and Wrinkles, sponsored by United Laboratories. Completed at 1 site in Philippines. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-26.

Sponsored by United Laboratories · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Skin Aging
  • Wrinkles
03

In context

Lead sponsor

United Laboratories is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • state
  • 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
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)

    Dietary Supplement: Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementAstaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)

    Drug pages: Astaxanthine · Lycopene · Alpha-Tocopherol

    The intervention is to be taken once daily, for 12 weeks.

  • Dietary supplementPlacebo

    The intervention is to be taken once daily, for 12 weeks.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. Proportion of subjects within each treatment group with a significant increase in skin hydration measured by a corneometer.

    Time frame: 12 weeks

  2. Proportion of subjects within each treatment group with a significant decrease in pigmentation measured by a mexameter.

    Time frame: 12 weeks

07

Study locations

1 site
  • PDC Building, 1440 Taft Avenue
    Manila, Metro Manila, Philippines
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03460860
Lead sponsor
United Laboratories
Responsible party
Sponsor
First posted
Mar 9, 2018
Start date
Mar 5, 2018
Primary completion
Oct 10, 2018
Completion
Feb 7, 2019
Last update
Jun 26, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Astaxanthine · Lycopene · Alpha-Tocopherol

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