A Study to Assess the Effects of an Oral Dietary Supplement on Overall Facial Appearance Among Healthy Adult Women With Existing Skin Damage From Sun Exposure

NCT ID: NCT01787461

Last Updated: 2015-03-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study hypothesis is that Imedeen will show effects on skin health, when compared to placebo over a 6 month intervention period with respect to changes in skin appearance, skin density, moisture, and in fine lines and wrinkles.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Photodamaged Skin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Imedeen

Imedeen is the study product

Group Type EXPERIMENTAL

Imedeen

Intervention Type DIETARY_SUPPLEMENT

Two tablets per day for 6 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Two tablets per day for 6 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Imedeen

Two tablets per day for 6 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

Two tablets per day for 6 months

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Imedeen Time Perfection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

In general good health and have no contraindications to the study product; Have Fitzpatrick Skin Type I-IV as determined by a trained evaluator. Have Glogau Classification of Photoaging of II or III as determined by the investigator.

Exclusion Criteria

Use of any dietary supplement, over-the-counter or prescription product with the indication of improving the appearance or condition of the skin within one month of baseline.

History of or current disease or condition of the skin that the investigator deems inappropriate for participation (eg, atopic skin, facial scars, psoriasis, eczema, other scaly inflammatory diseases).

Subjects who have had a facial cosmetic procedures (eg, fillers, toxins, facial peel) or invasive surgical procedures (eg, laser treatment or face lift) or other facial treatments by a physician or skin care professional within the last 6 to 9 months from baseline (pending procedure type) or plan to have a treatment during the study.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Baumann Cosmetic and Research Institute

Miami, Florida, United States

Site Status

TKL Research, Inc.

Fair Lawn, New Jersey, United States

Site Status

The Education & Research Foundation, Inc.

Lynchburg, Virginia, United States

Site Status

McDaniel Institute of Anti-Aging Research

Virginia Beach, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B5271003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Oligopin® on Skin Ageing
NCT04141059 COMPLETED NA
Effect of Platelet Rich Plasma on Photoaged Skin
NCT01372566 ACTIVE_NOT_RECRUITING PHASE1/PHASE2