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

March 30, 2011
June 23, 2011
March 2009
September 2009   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01381484 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Number of participants with adverse events Categorized adverse events
Same as current
Not Provided
Not Provided
 
Argireline in Treatment of Periorbital Wrinkles
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Wrinkles
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®)
  • 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.
    Intervention: Drug: 10% Argireline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
September 2009
September 2009   (final data collection date for primary outcome measure)

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)
Female
35 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01381484
Svarothai
Yes
Department of dermatology, Mahidol university
Mahidol University
Pacific Health Foundation
Principal Investigator: Supenya varothai, M.D. Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Mahidol University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP