Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03460860
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Skin Aging Wrinkles Dietary Supplement: Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU) Dietary Supplement: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 5, 2018
Estimated Primary Completion Date : August 10, 2018
Estimated Study Completion Date : September 7, 2018


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

Placebo Comparator: Placebo Dietary Supplement: Placebo
The intervention is to be taken once daily, for 12 weeks.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460860


Contacts
Layout table for location contacts
Contact: Juliene G Co, Ph.D. 858-1000 ext 8553 julieneco@gmail.com

Locations
Layout table for location information
Philippines
PDC Building, 1440 Taft Avenue Recruiting
Manila, Metro Manila, Philippines
Contact: Nenita Alberto, MD    (632) 5232519    albertonenita@yahoo.com   
Sponsors and Collaborators
United Laboratories

Layout table for additonal information
Responsible Party: United Laboratories
ClinicalTrials.gov Identifier: NCT03460860     History of Changes
Other Study ID Numbers: RD2017-06 (Anti-Aging Study)
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
Lycopene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Anti-Inflammatory Agents
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents