Evidence map›Paper›PMID 27042135›Full record

ArticleClinical, cosmetic and investigational dermatology2016

A placebo-controlled, double-blind clinical trial to evaluate the efficacy of Imedeen(®) Time Perfection(®) for improving the appearance of photodamaged skin.

Thomas J Stephens, Monya L Sigler, James H Herndon, Lisa Dispensa, Anne Le Moigne

9 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Clinical, cosmetic and investigational dermatology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 9 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04101825 nacompletednot on this mapstarted 2020, after this paper: background citation

Open, Non-comparative Study to Evaluate the Performance and Safety of the Medical Device AURALYA® (Hyaluronic Acid-dermal Filler) in the Treatment of Nasolabial Wrinkles to Obtain Facial Rejuvenation

TypeinterventionalSponsorI.R.A. Istituto Ricerche Applicate S.p.A.Ran2020 to 2021Enrolled60ConditionsNasolabial Fold, HypoplasticArmsAuralya
NCT04103125 nacompletednot on this mapstarted 2020, after this paper: background citation

Open, Non-Comparative Study To Evaluate The Performance And Safety Of The Medical Device JANESSE® (Hyaluronic Acid-Dermal Filler) In The Correction Of Facial Wrinkles

TypeinterventionalSponsorI.R.A. Istituto Ricerche Applicate S.p.A.Ran2020 to 2020Enrolled61ConditionsWrinkleArmsJanesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.
NCT04103918 nacompletednot on this mapstarted 2020, after this paper: background citation

Open, Non-Comparative Study To Evaluate The Performance And Safety Of The Medical Device Jalucomplex® (Hyaluronic Acid-Dermal Filler) In the Treatment Of Facial And Neck Wrinkles To Obtain Facial Rejuvanation

TypeinterventionalSponsorI.R.A. Istituto Ricerche Applicate S.p.A.Ran2020 to 2021Enrolled60ConditionsWrinkleArmsJalucomplex
NCT05239117 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Plenhyage® (Polymerised Polynucleotides Dermal Filler) in the Treatment of Dermal Tissue Defects

TypeinterventionalSponsorI.R.A. Istituto Ricerche Applicate S.p.A.Ran2022 to 2022Enrolled48ConditionsCicatrix, Lipodystrophy, PlaqueArmsPlenhyage
NCT05239130 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Auralya® (Hyaluronic Acid-dermal Filler) in the Treatment of Facial Dermal Tissue Defects

TypeinterventionalSponsorI.R.A. Istituto Ricerche Applicate S.p.A.Ran2022 to 2022Enrolled48ConditionsCicatrix, Lipodystrophy, PlaqueArmsAuralya
NCT05239156 nacompletednot on this mapstarted 2022, after this paper: background citation

Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Janesse® (Hyaluronic Acid-dermal Filler) in the Treatment of Facial Dermal Tissue Defects

TypeinterventionalSponsorI.R.A. Istituto Ricerche Applicate S.p.A.Ran2022 to 2022Enrolled48ConditionsCicatrix, Lipodystrophy, PlaqueArmsJanesse
NCT05239351 nacompletednot on this mapstarted 2022, after this paper: background citation

Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Jalucomplex® (Hyaluronic Acid-dermal Filler) in the Treatment of Facial and Neck Dermal Tissue Defects

TypeinterventionalSponsorI.R.A. Istituto Ricerche Applicate S.p.A.Ran2022 to 2022Enrolled48ConditionsCicatrix, Lipodystrophy, PlaqueArmsJalucomplex
NCT05345093 nacompletednot on this mapstarted 2022, after this paper: background citation

Open, Non-comparative, Multicentre, Interventional Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Ialuxid® Gel (Hydrogen Peroxide and Hyaluronic Acid) in the Treatment of Acne Vulgaris and Folliculitis.

TypeinterventionalSponsorBMG PharmaRan2022 to 2023Enrolled66ConditionsAcne Vulgaris, FolliculitisArmsIaluxid gel
NCT05649332 nacompletednot on this mapstarted 2023, after this paper: background citation

Open, Non-comparative, Multicentre, Interventional Post-market Clinical Follow-up (PMCF) Study to Evaluate the Performance and Safety of the Medical Device Argogen® (adsorbing Spray Powder for Exudates with Silver Ions) in the Treatment of Pressure Ulcers and Minor (first and Second Degree) Burn Wounds

TypeinterventionalSponsorSignorini Medicale S.r.l.Ran2023 to 2023Enrolled58ConditionsBurn Wound, Pressure Ulcers Stage II, Pressure Ulcers Stage IIIArmsArgogen (silver zeolite powder)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Skin Aging, Cellular Senescence and Natural Polyphenols.International journal of molecular sciences · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Thomas J StephensThomas J. Stephens and Associates, Inc., Richardson, TX, USA.
Monya L SiglerThomas J. Stephens and Associates, Inc., Richardson, TX, USA.
James H HerndonDermatology Center of Dallas, Dallas, TX, USA.
Lisa DispensaPfizer Consumer Healthcare, Madison, NJ, USA.
Anne Le MoignePfizer Consumer Healthcare, Madison, NJ, USA.
Pfizer (United States) · USStephens College · USDermatology Treatment & Research Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the efficacy of Imedeen Time Perfection for improving the appearance and condition of photoaged skin in healthy women.

methodsThis randomized, double-blind, placebo-controlled clinical trial enrolled healthy women, 35-60 years of age, with Fitzpatrick I-III and Glogau II-III skin types and mild-to-moderate facial fine lines/wrinkles. The eligible subjects were randomized to receive two tablets daily of either Imedeen Time Perfection (Imedeen) or a matching placebo for 12 weeks. Efficacy assessments included investigator rating of 16 photoaging parameters (ie, global facial appearance and 15 individual facial parameters and the average of all parameters), instrumentation (ie, ultrasound dermal density, moisture level of the stratum corneum, transepidermal water loss, cutometry), and subjects' self-assessment. Differences in the mean change from baseline to week 12 values on these outcomes were compared between Imedeen and placebo using analysis of variance or a paired t-test.

resultsSeventy-four subjects with primarily Fitzpatrick skin type III (78%-79%) and Glogau type III (53%-58%) completed the study (Imedeen: n=36; placebo: n=38). The mean difference in change from baseline to week 12 for global facial assessment significantly favored Imedeen over placebo (-0.52; P=0.0017). Additionally, the mean differences in the average of all facial photoaging parameters (-0.29), mottled hyperpigmentation (-0.25), tactile laxity (-0.24), dullness (-0.47), and tactile roughness (-0.62) significantly favored Imedeen over placebo (P≤0.05). Significantly greater increases in ultrasound dermal density (+11% vs +1%; P≤0.05) and stratum corneum moisturization (+30% vs +6%; P≤0.05) were also observed for Imedeen than for placebo. There were no significant differences on other instrumental outcomes.

conclusionThe results of this study suggest that Imedeen Time Perfection can positively affect the appearance of photoaged skin, moisturization, and skin density over 12 weeks of treatment.

Indexed as

dietary supplementmarine complexphotoaging

Identifiers

PMID27042135
PMCPMC4801055
OpenAlexW2298142647

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

and 3 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.