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Completed

NCT Number: NCT03460860

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.

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Key information

Conditions

Skin Aging Wrinkles

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PDC Building, 1440 Taft Avenue

Manila, National Capital Region, Philippines

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

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

Placebo

Dietary Supplement

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

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.

    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 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

Sponsors and collaborators

Lead sponsor

United Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 9, 2018
Registry last updated
Jun 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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