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

Pfizer194 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

194

Conditions

Photodamaged Skin

Interventions

ImedeenDIETARY_SUPPLEMENT

Two tablets per day for 6 months

PlaceboDIETARY_SUPPLEMENT

Two tablets per day for 6 months

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

Baumann Cosmetic and Research Institute

Miami, Florida, United States

TKL Research, Inc.

Fair Lawn, New Jersey, United States

The Education & Research Foundation, Inc.

Lynchburg, Virginia, United States

McDaniel Institute of Anti-Aging Research

Virginia Beach, Virginia, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 24

Secondary Outcomes

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

IPRC assessment was performed in accordance with the Canfield procedures and rated the improvement relative to Baseline. The investigators used an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).

Time frame: Week 24

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

Time frame: Baseline, Week 12

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

Investigator performed the assessment of face (Fine lines/wrinkles (L/W) of the periocular area (A), Fine lines/wrinkles of the perioral area, dark circles (dc) or "bags" under the eye, mottled hyperpigmentation (MH), sallowness/yellowing, roughness/texture) using a numerical severity rating scale of 0 to 9, where 0 to less than or equal to (\<=) 3 signifies Mild; greater than (\>) 3 to \<=6 signifies Moderate and \>6 to \<=9 signifies Severe.

Time frame: Baseline, Week 12, 24

Data from ClinicalTrials.gov

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

Investigator performed the assessment of decolletage and back of hands (crepyness, mottled hyperpigmentation \[MH\]) 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.

Time frame: Baseline, Week 12, 24

Participants Improvement Assessment of Face at Week 12 and 24

Participants performed the assessment of face (overall facial (OA) appearance, fine lines and wrinkles (L/W) present in the eye area, upper lip, or cheek areas, under eye dark circles (dc) or bags, discoloration \[uneven, patchy, blotchy areas of light and dark, age spots, liver spots\], complexion/glow \[bright radiant appearance\] and smoothness) at Baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the facial parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).

Time frame: Baseline, Week 12, 24

Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24

Participants performed the assessment of decolletage (decolletage overall, decolletage-wrinkling/crinkling (W/C), decolletage-discoloration (DD) and back of hands (back of hands overall, back of hands (BOH) - Fine lines/wrinkles (L/W), back of hands - discoloration) and Body - Dryness (BD) Overall at baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the Decolletage, Back of Hands and Body parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).

Time frame: Baseline, Week 12, 24

Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24

DermaLab Combo Skin Lab with an 8-pin probe was used to measure hydration (corneometry). Hydration measurements of the left cheek, left inner arm, and left outer arm were taken (up to 3 measurement).

Time frame: Baseline, Week 6, 12, 18, 24

Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24

Trans-epidermal water loss (TEWL) measurements were done using DermaLab Combo SkinLab with a cylindrical diffusion chamber (10 mm \[millimeter\] diameter) containing 2 combined humidity/temperature sensors to determine the amount of water vapor that moves across the stratum corneum. TEWL measurements were taken on the left cheek and the left inner and outer arm (up to 3 measurement).

Time frame: Baseline, Week 6, 12, 18, 24

Change From Baseline in Skin Thickness at Week 6, 12,18 and 24

Skin thickness was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).

Time frame: Baseline, Week 6, 12, 18, 24

Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode)

Skin density was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system with 100 percent (%) calibration mode. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).

Time frame: Baseline, Week 6, 12, 18, 24