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Completed

NCT Number: NCT01381484

Argireline in Treatment of Periorbital Wrinkles

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

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Key information

Conditions

Wrinkles

Age range

35 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

About this study

Argireline has mechanism of action that significantly inhibited neurotransmitter release with a potency similar to that of BoNTA. Inhibition of neurotransmitter release was due to the interference of the hexapeptide with the formation and/or stability of SNARE complex. Notably, this peptide did not exhibit in vivo oral toxicity nor primary irritation at high doses. These findings demonstrate that Argireline is a anti-wrinkle peptide that emulates the action of currently used BoNTs.

In vivo study, Topical Argireline 10% is applied on lateral preorbital area twice daily for 30 days. The result demonstrates a significant anti-wrinkle activity by decreased skin wrinkle 30%. These findings demonstrate a significant anti-wrinkle activity for Argireline, in agreement with its in vitro and cellular activities. Topical Argireline represents a bio-safe alternative to BoNTs in anti-wrinkle therapy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

10% Argireline

Drug

10% Argireline (La jolie gel®, Pacific health care, Thailand) were instructed to apply the gel over the face and periorbital area twice daily for a period of 3 months.

Other names: 10% Argireline (La jolie gel®)

Primary outcomes

  1. Efficacy

    Time frame: 3 months

    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. Safety

    Time frame: 3 months

    Number of participants with adverse events Categorized adverse events

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Pacific Health Foundation

Registry information

Official study title

Efficacy and Safety of Topical Argireline in the Treatment of Periorbital Wrinkles

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 27, 2011
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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