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

June 24, 2019 updated by: United Laboratories

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
    • Metro Manila
      • Manila, Metro Manila, Philippines
        • PDC Building, 1440 Taft Avenue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
The intervention is to be taken once daily, for 12 weeks.
Experimental: Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)
Dietary supplement: Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)
The intervention is to be taken once daily, for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects within each treatment group with a significant increase in skin hydration measured by a corneometer.
Time Frame: 12 weeks
12 weeks
Proportion of subjects within each treatment group with a significant decrease in pigmentation measured by a mexameter.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2018

Primary Completion (Actual)

October 10, 2018

Study Completion (Actual)

February 7, 2019

Study Registration Dates

First Submitted

March 4, 2018

First Submitted That Met QC Criteria

March 4, 2018

First Posted (Actual)

March 9, 2018

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 24, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD2017-06 (Anti-Aging Study)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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