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

NCT01787461 | Completed Phase 4 Results

• 1 other identifier: B5271003
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Photodamaged Skin

Keywords

Trial assessing effects of an oral dietary supplement on overall facial appearance among healthy women with photodamaged skin.

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24

  IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (\<=) 3 signifies Mild; greater than (\>) 3 to \<=6 signifies Moderate and \>6 to \<=9 signifies Severe.

  Baseline, Week 24

Secondary Outcomes (10)

• Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24

  Week 24

• Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12

  Baseline, Week 12

• Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24

  Baseline, Week 12, 24

• Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24

  Baseline, Week 12, 24

• Participants Improvement Assessment of Face at Week 12 and 24

  Baseline, Week 12, 24

Study Arms (2)

Imedeen

EXPERIMENTAL

Imedeen is the study product

Dietary Supplement: Imedeen

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Imedeen DIETARY_SUPPLEMENT

Two tablets per day for 6 months

Also known as: Imedeen Time Perfection

Imedeen

Placebo DIETARY_SUPPLEMENT

Two tablets per day for 6 months

Placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Baumann Cosmetic and Research Institute

Miami, Florida, 33137, United States

Location

TKL Research, Inc.

Fair Lawn, New Jersey, 07410, United States

Location

The Education & Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

McDaniel Institute of Anti-Aging Research

Virginia Beach, Virginia, 23462, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Imedeen

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: February 8, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 18, 2015
• Results First Posted: March 18, 2015

Record last verified: 2015-03

Locations

US (4)