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

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Pfizer

Status and phase

Completed
Phase 4

Conditions

Photodamaged Skin

Treatments

Dietary Supplement: Imedeen
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01787461
B5271003

Details and patient eligibility

About

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.

Enrollment

194 patients

Sex

Female

Ages

35 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

194 participants in 2 patient groups, including a placebo group

Imedeen
Experimental group
Description:
Imedeen is the study product
Treatment:
Dietary Supplement: Imedeen
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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