Argireline in Treatment of Periorbital Wrinkles

NCT ID: NCT01381484

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Wrinkles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

This group received placebo gel and requested to apply periorbital area and over the face for 3 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Study group

This group received La Jolie Gel and requested to apply periorbital area and over the face for 3 months.

Group Type EXPERIMENTAL

10% Argireline

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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10% Argireline (La jolie gel®)

Eligibility Criteria

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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)
Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pacific Health Foundation

OTHER

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Mahidol university

Principal Investigators

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Supenya varothai, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Locations

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Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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Blanes-Mira C, Clemente J, Jodas G, Gil A, Fernandez-Ballester G, Ponsati B, Gutierrez L, Perez-Paya 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.

Reference Type BACKGROUND
PMID: 18498523 (View on PubMed)

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. doi: 10.1016/j.bmcl.2007.03.039. Epub 2007 Mar 16.

Reference Type BACKGROUND
PMID: 17418566 (View on PubMed)

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.

Reference Type RESULT
PMID: 18377617 (View on PubMed)

Klein AW. Complications, adverse reactions, and insights with the use of botulinum toxin. Dermatol Surg. 2003 May;29(5):549-56; discussion 556. doi: 10.1046/j.1524-4725.2003.29129.x. No abstract available.

Reference Type RESULT
PMID: 12752527 (View on PubMed)

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. doi: 10.1111/j.1468-3083.2004.01180.x.

Reference Type RESULT
PMID: 15857456 (View on PubMed)

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.

Reference Type RESULT
PMID: 18489289 (View on PubMed)

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. doi: 10.1016/j.abb.2005.11.001. Epub 2005 Nov 28.

Reference Type RESULT
PMID: 16364234 (View on PubMed)

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. doi: 10.1046/j.1524-4725.2003.29150.x.

Reference Type RESULT
PMID: 12786700 (View on PubMed)

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. doi: 10.1097/00006534-200011000-00023. No abstract available.

Reference Type RESULT
PMID: 11083570 (View on PubMed)

Manaloto RM, Alster TS. Periorbital rejuvenation: a review of dermatologic treatments. Dermatol Surg. 1999 Jan;25(1):1-9. doi: 10.1046/j.1524-4725.1999.08049.x.

Reference Type RESULT
PMID: 9935084 (View on PubMed)

Other Identifiers

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Svarothai

Identifier Type: -

Identifier Source: org_study_id

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