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

Skin Aging Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03460860
• Other study ID #: RD2017-06 (Anti-Aging Study)
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: February 7, 2019

Study information

• Verified date: June 2019
• Source: United Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 7, 2019
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Aging
• Wrinkles

Intervention

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

Locations

Country	Name	City	State
Philippines	PDC Building, 1440 Taft Avenue	Manila	Metro Manila

Sponsors (1)

Lead Sponsor	Collaborator
United Laboratories

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of subjects within each treatment group with a significant increase in skin hydration measured by a corneometer.		12 weeks
Secondary	Proportion of subjects within each treatment group with a significant decrease in pigmentation measured by a mexameter.		12 weeks