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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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Baumann Cosmetic and Research Institute
Miami, Florida, 33137 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Photodamaged Skin
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT01787461
Pfizer
Completed
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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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
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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  • Dietary Supplement: Imedeen
    Two tablets per day for 6 months
    Other Name: Imedeen Time Perfection
  • Dietary Supplement: Placebo
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  • Experimental: Imedeen
    Imedeen is the study product
    Intervention: Dietary Supplement: Imedeen
  • Placebo Comparator: Placebo
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Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
March 2014
March 2014   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: Female
35 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01787461
B5271003
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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