NCT03460860

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2019

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

7 months

First QC Date

March 4, 2018

Last Update Submit

June 24, 2019

Conditions

Skin AgingWrinkles

Outcome Measures

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.

    12 weeks

Secondary Outcomes (2)

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

    12 weeks

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

    12 weeks

Study Arms (2)

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

Interventions

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

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

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

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

Placebo

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PDC Building, 1440 Taft Avenue

Manila, National Capital Region, Philippines

Location

MeSH Terms

Interventions

astaxanthineLycopenealpha-Tocopherol

Intervention Hierarchy (Ancestors)

CarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological FactorsTocopherolsVitamin EBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2018

First Posted

March 9, 2018

Study Start

March 5, 2018

Primary Completion

October 10, 2018

Study Completion

February 7, 2019

Last Updated

June 26, 2019

Record last verified: 2019-06

Locations

PH(1)