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Argireline in Treatment of Periorbital Wrinkles

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01381484
First Posted: June 27, 2011
Last Update Posted: June 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pacific Health Foundation
Information provided by:
Mahidol University
  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
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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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:
  • Safety [ Time Frame: 3 months ]
    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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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
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:
Farage MA, Miller KW, Elsner P, Maibach HI. Intrinsic and extrinsic factors in skin ageing: a review. Int J Cosmet Sci. 2008 Apr;30(2):87-95. doi: 10.1111/j.1468-2494.2007.00415.x. Review.
Klein AW. Complications, adverse reactions, and insights with the use of botulinum toxin. Dermatol Surg. 2003 May;29(5):549-56; discussion 556. Review.
Brown MB, Jones SA. Hyaluronic acid: a unique topical vehicle for the localized delivery of drugs to the skin. J Eur Acad Dermatol Venereol. 2005 May;19(3):308-18. Review.
Abella ML. Evaluation of anti-wrinkle efficacy of adenosine-containing products using the FOITS technique. Int J Cosmet Sci. 2006 Dec;28(6):447-51. doi: 10.1111/j.1467-2494.2006.00349.x.
Senni K, Gueniche F, Foucault-Bertaud A, Igondjo-Tchen S, Fioretti F, Colliec-Jouault S, Durand P, Guezennec J, Godeau G, Letourneur D. Fucoidan a sulfated polysaccharide from brown algae is a potent modulator of connective tissue proteolysis. Arch Biochem Biophys. 2006 Jan 1;445(1):56-64. Epub 2005 Nov 28.
Narins RS, Brandt F, Leyden J, Lorenc ZP, Rubin M, Smith S. A randomized, double-blind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol Surg. 2003 Jun;29(6):588-95.
Rohrich RJ. The increasing popularity of cosmetic surgery procedures: a look at statistics in plastic surgery. Plast Reconstr Surg. 2000 Nov;106(6):1363-5.
Manaloto RM, Alster TS. Periorbital rejuvenation: a review of dermatologic treatments. Dermatol Surg. 1999 Jan;25(1):1-9. Review.
Blanes-Mira C, Clemente J, Jodas G, Gil A, Fernández-Ballester G, Ponsati B, Gutierrez L, Pérez-Payá E, Ferrer-Montiel A. A synthetic hexapeptide (Argireline) with antiwrinkle activity. Int J Cosmet Sci. 2002 Oct;24(5):303-10. doi: 10.1046/j.1467-2494.2002.00153.x.
Tokiwa Y, Kitagawa M, Raku T, Yanagitani S, Yoshino K. Enzymatic synthesis of arbutin undecylenic acid ester and its inhibitory effect on melanin synthesis. Bioorg Med Chem Lett. 2007 Jun 1;17(11):3105-8. Epub 2007 Mar 16.

Responsible Party: Department of dermatology, Mahidol university
ClinicalTrials.gov Identifier: NCT01381484     History of Changes
Other Study ID Numbers: Svarothai
First Submitted: March 30, 2011
First Posted: June 27, 2011
Last Update Posted: June 27, 2011
Last Verified: March 2011

Keywords provided by Mahidol University:
Periorbital wrinkles
Efficacy and safety


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