Phase 4 N=194 Randomized Double-blind Prevention

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

Photodamaged Skin

Bottom Line

View on ClinicalTrials.gov: NCT01787461 ↗

Enrolled (actual)

194

Serious AEs

1.0%

Results posted

Mar 2015

Primary outcome: Primary: Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24 — 6.04; 5.81; 0.6; 0.7 units on scale — p=0.358

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Imedeen (Dietary_supplement); Placebo (Dietary_supplement)
Age: Adult, Older Adult · 35+ yrs
Sex: Female
Sponsor: Pfizer
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24	6.04; 5.81; 0.6; 0.7	0.358
SECONDARY Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24	-0.2; -0.1	0.568
SECONDARY Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12	6.04; 5.81; 0.4; 0.4	0.797
SECONDARY Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24	5.95; 5.79; 4.89; 4.69; 5.68; 5.34	0.965
SECONDARY Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24	4.65; 4.56; 5.09; 5.08; 5.37; 5.19	0.901
SECONDARY Participants Improvement Assessment of Face at Week 12 and 24	5.67; 5.60; 6.51; 6.46; 5.80; 5.82	0.688
SECONDARY Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24	5.34; 5.19; 5.59; 5.48; 5.88; 6.06	0.017 sig
SECONDARY Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24	231.7; 238.7; -5.2; 1.9; 16.7; 20.0	0.587
SECONDARY Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24	11.7; 11.0; -0.0; 0.4; 0.0; 0.8	0.214
SECONDARY Change From Baseline in Skin Thickness at Week 6, 12,18 and 24	1568.2; 1531.1; 2.4; -33.9; 11.3; -37.1	0.266
SECONDARY Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode)	10.5; 10.3; -0.1; -0.7; -0.1; -0.8	0.458

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01787461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.