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Trial · Interventional

CompletedPhase 3Registry data

Argireline in Treatment of Periorbital Wrinkles

NCTNCT01381484 (opens ClinicalTrials.gov in a new tab)Other idSvarothai
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
70 participants (actual)
Sponsor
Mahidol University · Other
Design
Randomized · Triple masking
Countries
1 country

Thailand

Start
Mar 2009
Primary completion
Sept 2009
Completion
Sept 2009
First posted
27 Jun 2011 (estimated)
Last update posted
27 Jun 2011 (estimated)
Conditions
Wrinkles

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20092010
  1. Ph 3

    Argireline in Treatment of Periorbital Wrinkles

    NCT01381484

    Mar 2009 to Sept 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine whether La Jolie gel is effective in the treatment of periorbital wrinkles.

Interventions

  • 10% ArgirelineDrug

Arms2

  • No intervention

    Placebo

    This group received placebo gel and requested to apply periorbital area and over the face for 3 months.

  • Experimental

    Study group

    This group received La Jolie Gel and requested to apply periorbital area and over the face for 3 months.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Efficacy

    Time frame · 3 months

    Registry description

    Objective evaluation * Noninvasive measurement by skin bioengineering technique e.g. visioscan, corneometer, cutometer * Comparative photographic evaluation by certified dermatologists Subjective evaluation * Patient Self assessment satifaction review

Secondary outcomes(1)

  1. Safety

    Time frame · 3 months

    Registry description

    Number of participants with adverse events Categorized adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2002

7 results

A synthetic hexapeptide (Argireline) with antiwrinkle activity.

Blanes-Mira et al. 2002International journal of cosmetic sciencecited by 92

PMID 18498523DOI 10.1046/j.1467-2494.2002.00153.xPUB-18498523

Full text at the publisher7 results
Publisher pageSee results (7)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultFarage MA, Miller KW, Elsner P, Maibach HI. Intrinsic and extrinsic factors in skin ageing: a review. Int J Cosmet Sci. 2008 Apr;30(2):87-95. doi: 10.1111/j.1468-2494.2007.00415.x. PMID 18377617
  • ResultKlein AW. Complications, adverse reactions, and insights with the use of botulinum toxin. Dermatol Surg. 2003 May;29(5):549-56; discussion 556. doi: 10.1046/j.1524-4725.2003.29129.x. No abstract available. PMID 12752527
  • ResultBrown MB, Jones SA. Hyaluronic acid: a unique topical vehicle for the localized delivery of drugs to the skin. J Eur Acad Dermatol Venereol. 2005 May;19(3):308-18. doi: 10.1111/j.1468-3083.2004.01180.x. PMID 15857456
  • ResultAbella ML. Evaluation of anti-wrinkle efficacy of adenosine-containing products using the FOITS technique. Int J Cosmet Sci. 2006 Dec;28(6):447-51. doi: 10.1111/j.1467-2494.2006.00349.x. PMID 18489289
  • ResultSenni K, Gueniche F, Foucault-Bertaud A, Igondjo-Tchen S, Fioretti F, Colliec-Jouault S, Durand P, Guezennec J, Godeau G, Letourneur D. Fucoidan a sulfated polysaccharide from brown algae is a potent modulator of connective tissue proteolysis. Arch Biochem Biophys. 2006 Jan 1;445(1):56-64. doi: 10.1016/j.abb.2005.11.001. Epub 2005 Nov 28. PMID 16364234
  • ResultNarins RS, Brandt F, Leyden J, Lorenc ZP, Rubin M, Smith S. A randomized, double-blind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol Surg. 2003 Jun;29(6):588-95. doi: 10.1046/j.1524-4725.2003.29150.x. PMID 12786700
  • ResultRohrich RJ. The increasing popularity of cosmetic surgery procedures: a look at statistics in plastic surgery. Plast Reconstr Surg. 2000 Nov;106(6):1363-5. doi: 10.1097/00006534-200011000-00023. No abstract available. PMID 11083570
  • ResultManaloto RM, Alster TS. Periorbital rejuvenation: a review of dermatologic treatments. Dermatol Surg. 1999 Jan;25(1):1-9. doi: 10.1046/j.1524-4725.1999.08049.x. PMID 9935084

Eligibility

Who could join, as posted.

Sex
Female
Age
from 35 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * healthy woman at 35-45 years old * Presence of periorbital wrinkles Exclusion Criteria: * Pregnancy * Nursing * Keloids /scar at periorbital area * pre-treatment with topical periorbital products within 1 month * Botulinum toxin A injection,facial plastic surgery within 1 year * Allergic to active ingredients including acetyl hexapeptide-3 Argireline®, sodium hyaluronate,adenosine,arbutin,fucus vesiculosus)

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