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Argireline in Treatment of Periorbital Wrinkles

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ClinicalTrials.gov Identifier: NCT01381484
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
Sponsor:
Collaborator:
Pacific Health Foundation
Information provided by:
Mahidol University

Study Description
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Brief Summary:
The purpose of this study is to determine whether La Jolie gel is effective in the treatment of periorbital wrinkles.

Condition or disease Intervention/treatment Phase
Wrinkles Drug: 10% Argireline Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Topical Argireline in the Treatment of Periorbital Wrinkles
Study Start Date : March 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

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Arms and Interventions
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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 Name: 10% Argireline (La jolie gel®)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Safety [ Time Frame: 3 months ]
    Number of participants with adverse events Categorized adverse events


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 45 Years   (Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381484


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

Other Publications:

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Responsible Party: Department of dermatology, Mahidol university
ClinicalTrials.gov Identifier: NCT01381484    
Other Study ID Numbers: Svarothai
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: March 2011
Keywords provided by Mahidol University:
Periorbital wrinkles
Efficacy and safety