Argireline in Treatment of Periorbital Wrinkles

NCT01381484 | Completed Phase 3 DMC

• 1 other identifier: Svarothai
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Wrinkles

Keywords

Periorbital wrinkles; Efficacy and safety

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Safety

  3 months

Study Arms (2)

Placebo

NO INTERVENTION

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

Study group

EXPERIMENTAL

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

Drug: 10% Argireline

Interventions

10% Argireline 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.

Also known as: 10% Argireline (La jolie gel®)

Study group

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy woman at 35-45 years old
• Presence of periorbital wrinkles

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mahidol University: lead
• Pacific Health Foundation: collaborator

Study Sites (1)

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

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (10)

• 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.

  PMID: 18498523 BACKGROUND

• 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.

  PMID: 17418566 BACKGROUND

• 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.

  PMID: 18377617 RESULT

• 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.

  PMID: 12752527 RESULT

• 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.

  PMID: 15857456 RESULT

• 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.

  PMID: 18489289 RESULT

• 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.

  PMID: 16364234 RESULT

• 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.

  PMID: 12786700 RESULT

• 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.

  PMID: 11083570 RESULT

• 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.

  PMID: 9935084 RESULT

MeSH Terms

Interventions

acetyl-glutamyl-glutamyl-methionyl-glutaminyl-arginyl-argininamide

Study Officials

• Supenya varothai, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: June 27, 2011
• Study Start: March 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 27, 2011

Record last verified: 2011-03

Locations

TH (1)