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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03460860
Enrollment
100
Registered
2018-03-09
Start date
2018-03-05
Completion date
2019-02-07
Last updated
2019-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Aging, Wrinkles

Brief 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.

Interventions

DIETARY_SUPPLEMENTAstaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)

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

DIETARY_SUPPLEMENTPlacebo

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

Sponsors

United Laboratories
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes

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 informed consent

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 * Immunocompromised 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 informed consent

Design outcomes

Primary

MeasureTime frameDescription
Proportion of subjects within each treatment group with a significant decrease in skin wrinkling measured by a validated Crow's Feet Wrinkle scale.12 weeksThe 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.

Secondary

MeasureTime frame
Proportion of subjects within each treatment group with a significant decrease in pigmentation measured by a mexameter.12 weeks
Proportion of subjects within each treatment group with a significant increase in skin hydration measured by a corneometer.12 weeks

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026