Clinical trial NCT01787461: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Photodamaged Skin
Keywords: Trial assessing effects of an oral dietary supplement on overall facial appearance among healthy women with photodamaged skin.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 194
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24
timeFrame: Week 24
measure: Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Participants Improvement Assessment of Face at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24
timeFrame: Baseline, Week 6, 12, 18, 24
measure: Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24
timeFrame: Baseline, Week 6, 12, 18, 24
measure: Change From Baseline in Skin Thickness at Week 6, 12,18 and 24
timeFrame: Baseline, Week 6, 12, 18, 24
measure: Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode)
timeFrame: Baseline, Week 6, 12, 18, 24
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baumann Cosmetic and Research Institute
state: Florida
city: Fair Lawn
country: United States
facility: TKL Research, Inc.
state: New Jersey
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
city: Virginia Beach
country: United States
facility: McDaniel Institute of Anti-Aging Research
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: