Argireline in Treatment of Periorbital Wrinkles

Study Overview
=================
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.

Official Title
-----------------
Efficacy and Safety of Topical Argireline in the Treatment of Periorbital Wrinkles

Conditions
-----------------
Wrinkles

Intervention / Treatment
-----------------
* Drug: 10% Argireline


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Placebo<br>This group received placebo gel and requested to apply periorbital area and over the face for 3 months. | |
| Experimental: Study group<br>This group received La Jolie Gel and requested to apply periorbital area and over the face for 3 months. | Drug: 10% Argireline<br>* 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.<br>* Other names: 10% Argireline (La jolie gel®);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of participants with adverse events Categorized adverse events | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periorbital wrinkles, Efficacy and safety