Argireline in Treatment of Periorbital Wrinkles

Phase 3

Completed

• Conditions: Wrinkles
• Interventions: Drug: 10% Argireline

• Registration Number: NCT01381484
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2011-03
• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-06-23
• Last Update Submitted: 2011-06-23
• Study First Posted: 2011-06-27
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	10% Argireline	This group received La Jolie Gel and requested to apply periorbital area and over the face for 3 months.

Primary Outcome Measures

Name	Time	Method
Efficacy	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 Outcome Measures

Name	Time	Method
Safety	3 months	Number of participants with adverse events Categorized adverse events

Trial Locations

Locations (1)

Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkoknoi, Bangkok, Thailand