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Argireline in Treatment of Periorbital Wrinkles

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01381484
Enrollment
70
Registered
2011-06-27
Start date
2009-03-31
Completion date
2009-09-30
Last updated
2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wrinkles

Keywords

Periorbital wrinkles, Efficacy and safety

Brief summary

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

Detailed description

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.

Interventions

DRUG10% Argireline

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.

Sponsors

Pacific Health Foundation
CollaboratorOTHER
Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 45 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Efficacy3 monthsObjective 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

MeasureTime frameDescription
Safety3 monthsNumber of participants with adverse events Categorized adverse events

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026