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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01787461
First received: December 5, 2012
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Photodamaged Skin
Dietary Supplement: Imedeen
Dietary Supplement: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Double-blind, Placebo-Controlled Trial Assessing The Effects of an Oral Dietary Supplement Containing Marine and Plant Extracts on Overall Facial Skin Appearance Among Healthy Adult Women With Photo-aged Skin

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Investigator's Global Assessment (IGA) of subject's overall facial appearance at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Investigator will examine changes in the overall facial appearance assessing fine lines and wrinkles of the periocular and perioral areas, dark circles, mottled hyperpigmentation, sallowness and roughness


Secondary Outcome Measures:
  • Photograph assessment of the subject's overall facial appearance at Week 24 as compared to Baseline by an Independent Panel Review Committee (IPRC) using an improvement scale [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Photograph assessment of the subject's overall facial appearance at Week 24 as compared to Baseline by an Independent Panel Review Committee (IPRC) using an improvement scale

  • Investigator's Global Assessment of subject's overall facial appearance at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Investigator's Global Assessment of subject's overall facial appearance at Week 12 assessing fine lines and wrinkles of the periocular and perioral areas, dark circles, mottled hyperpigmentation, sallowness and roughness

  • Investigator's assessment of face, decolletage, and back of hands on photoaging parameters using a numerical severity scale [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
    Investigator's assessment of face, decolletage, and back of hands

  • Corneometry (hydration) Trans-Epidermal Water Loss Ultrasound (skin density) [ Time Frame: Week 6, 12, 18, 24 ] [ Designated as safety issue: No ]
    Corneometry (hydration) Trans-Epidermal Water Loss Ultrasound (skin density)


Enrollment: 194
Study Start Date: January 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imedeen
Imedeen is the study product
Dietary Supplement: Imedeen
Two tablets per day for 6 months
Other Name: Imedeen Time Perfection
Placebo Comparator: Placebo Dietary Supplement: Placebo
Two tablets per day for 6 months

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787461

Locations
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33137
United States, New Jersey
Pfizer Investigational Site
Fair Lawn, New Jersey, United States, 07410
United States, Virginia
Pfizer Investigational Site
Lynchburg, Virginia, United States, 24501
Pfizer Investigational Site
Virginia Beach, Virginia, United States, 23462
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01787461     History of Changes
Other Study ID Numbers: B5271003
Study First Received: December 5, 2012
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
Trial assessing effects of an oral dietary supplement on overall facial appearance among healthy women with photodamaged skin.

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014