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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
History of Changes
  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 May 19, 2013