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

Not Applicable

Completed

• Conditions: Skin Aging; Wrinkles
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)

• Registration Number: NCT03460860
• Lead Sponsor: United Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-04
• Study First Submitted QC: 2018-03-04
• Study Start: 2018-03-05
• Study First Posted: 2018-03-09
• Primary Completion: 2018-10-10
• Study Completion: 2019-02-07
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-24
• Last Update Posted: 2019-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)	Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects within each treatment group with a significant decrease in skin wrinkling measured by a validated Crow's Feet Wrinkle scale.	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

PDC Building, 1440 Taft Avenue; 🇵🇭 Manila, Metro Manila, Philippines