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Photodamaged SkinPhase 4NCT01787461

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

A Phase 4 study testing Imedeen in people with Photodamaged Skin, run by Pfizer at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Photodamaged Skin
What is being tested?
Imedeen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
194 participants
Where
4 sitesUnited States
Study dates
Jan 2013to Mar 2014
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

4 sites in 1 country.

United States4 sites
  • TKL Research, Inc.

    Fair Lawn, New Jersey, 07410

  • The Education & Research Foundation, Inc.

    Lynchburg, Virginia, 24501

  • Baumann Cosmetic and Research Institute

    Miami, Florida, 33137

  • McDaniel Institute of Anti-Aging Research

    Virginia Beach, Virginia, 23462

Other trials in United States

About this study

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

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.

Being tested
Imedeen, Placebo
Keywords
Trial assessing effects of an oral dietary supplement on overall facial appearance among healthy women with photodamaged skin.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImedeenDietary supplement

    Also called Imedeen Time Perfection

    Two tablets per day for 6 months

  • PlaceboDietary supplement

    Two tablets per day for 6 months

Study groups in NCT01787461
Study groupRoleWhat they receive
ImedeenExperimentalImedeen is the study product
Receives: Dietary Supplement: Imedeen
PlaceboPlacebo comparatorNot described
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 24

Secondary outcomes (10)
  1. 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).

    Measured: Week 24

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

    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.

    Measured: Baseline, Week 12

  3. 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.

    Measured: Baseline, Week 12, 24

  4. 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.

    Measured: Baseline, Week 12, 24

  5. 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).

    Measured: Baseline, Week 12, 24

  6. 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).

    Measured: Baseline, Week 12, 24

  7. 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).

    Measured: Baseline, Week 6, 12, 18, 24

  8. 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).

    Measured: Baseline, Week 6, 12, 18, 24

  9. 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).

    Measured: Baseline, Week 6, 12, 18, 24

  10. 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).

    Measured: Baseline, Week 6, 12, 18, 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01787461
Sponsor's protocol ID
B5271003
Status last verified
Mar 2015
First submitted
5 Dec 2012
Last updated
18 Mar 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Imedeen in people with Photodamaged Skin, run by Pfizer at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.

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