Argireline in Treatment of Periorbital Wrinkles

Wrinkles Clinical Trial

Official title:

Efficacy and Safety of Topical Argireline in the Treatment of Periorbital Wrinkles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381484
• Other study ID #: Svarothai
• Status: Completed
• Phase: Phase 3
• First received: March 30, 2011
• Last updated: June 23, 2011
• Start date: March 2009
• Est. completion date: September 2009

Study information

• Verified date: March 2011
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wrinkles

Intervention

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.

Locations

Country	Name	City	State
Thailand	Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkoknoi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Pacific Health Foundation

Country where clinical trial is conducted

Thailand, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Klein AW. Complications, adverse reactions, and insights with the use of botulinum toxin. Dermatol Surg. 2003 May;29(5):549-56; discussion 556. Review. — View Citation

Manaloto RM, Alster TS. Periorbital rejuvenation: a review of dermatologic treatments. Dermatol Surg. 1999 Jan;25(1):1-9. Review. — View Citation

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. — View Citation

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. — View Citation

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 Bioche — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	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	3 months	Yes
Secondary	Safety	Number of participants with adverse events Categorized adverse events	3 months	Yes