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

Study Overview
=================
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.

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

Conditions
-----------------
Skin Aging, Wrinkles

Intervention / Treatment
-----------------
* Dietary Supplement: Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

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. | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |