Argireline in Treatment of Periorbital Wrinkles

June 23, 2011 updated by: Mahidol University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 10% 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.
Other Names:
  • 10% Argireline (La jolie gel®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Pacific Health Foundation

Investigators

  • Principal Investigator: Supenya varothai, M.D., Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

March 30, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 23, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Svarothai

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wrinkles

Clinical Trials on 10% Argireline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe