CompletedNCT03460860Updated Jun 26, 2019

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

An interventional study of Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU) and Placebo in Skin Aging and Wrinkles, sponsored by United Laboratories. Completed at 1 site in Philippines. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-26.

Sponsored by United Laboratories · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 30 Years to 60 Years
Sex: All

Study 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.

Conditions studied

Skin Aging
Wrinkles

Who can participate

Ages eligible: 30 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 100 participants (actual)

Study arms

Experimental
Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)
Dietary Supplement: Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)
Placebo comparator
Placebo
Dietary Supplement: Placebo

Interventions

Dietary supplementAstaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)
The intervention is to be taken once daily, for 12 weeks.
Dietary supplementPlacebo
The intervention is to be taken once daily, for 12 weeks.

What researchers measure

Primary outcomes

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.
Time frame: 12 weeks

Secondary outcomes

Proportion of subjects within each treatment group with a significant increase in skin hydration measured by a corneometer.
Time frame: 12 weeks
Proportion of subjects within each treatment group with a significant decrease in pigmentation measured by a mexameter.
Time frame: 12 weeks

Study locations

1 site

PDC Building, 1440 Taft Avenue
Manila, Metro Manila, Philippines

Registry details

Key details

Study ID: NCT03460860
Lead sponsor: United Laboratories
Responsible party: Sponsor
First posted: Mar 9, 2018
Start date: Mar 5, 2018
Primary completion: Oct 10, 2018
Completion: Feb 7, 2019
Last update: Jun 26, 2019

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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