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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 10, 2018

Interventions

  • Dietary Supplement: Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)
    • The intervention is to be taken once daily, for 12 weeks.
  • Dietary Supplement: Placebo
    • The intervention is to be taken once daily, for 12 weeks.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • United Laboratories
  • Provider of Information About this Clinical Study
    • Sponsor

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