Argireline in Treatment of Periorbital Wrinkles

This study has been completed.
Sponsor:
Collaborator:
Pacific Health Foundation
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01381484
First received: March 30, 2011
Last updated: June 23, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention Phase
Wrinkles
Drug: 10% Argireline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Topical Argireline in the Treatment of Periorbital Wrinkles

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    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:
  • Safety [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events Categorized adverse events


Enrollment: 70
Study Start Date: March 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 10% Argireline (La jolie gel®)

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.

  Eligibility

Ages Eligible for Study:   35 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381484

Locations
Thailand
Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Pacific Health Foundation
Investigators
Principal Investigator: Supenya varothai, M.D. Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
  More Information

Publications:

Responsible Party: Department of dermatology, Mahidol university
ClinicalTrials.gov Identifier: NCT01381484     History of Changes
Other Study ID Numbers: Svarothai
Study First Received: March 30, 2011
Last Updated: June 23, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Periorbital wrinkles
Efficacy and safety

ClinicalTrials.gov processed this record on April 17, 2014