Argireline in Treatment of Periorbital Wrinkles

This study has been completed.

Sponsor:

Collaborator:

Pacific Health Foundation

Information provided by:

Mahidol University

ClinicalTrials.gov Identifier:

NCT01381484

First received: March 30, 2011

Last updated: June 23, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 30, 2011

Last Updated Date

June 23, 2011

Start Date ^ICMJE

March 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01381484 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Number of participants with adverse events Categorized adverse events

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Argireline in Treatment of Periorbital Wrinkles

Official Title ^ICMJE

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

Brief Summary

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Wrinkles

Intervention ^ICMJE

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®)

Study Arm (s)

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.

Intervention: Drug: 10% Argireline

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Female

Ages

35 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT01381484

Other Study ID Numbers ^ICMJE

Svarothai

Has Data Monitoring Committee

Yes

Responsible Party

Department of dermatology, Mahidol university

Study Sponsor ^ICMJE

Mahidol University

Collaborators ^ICMJE

Pacific Health Foundation

Investigators ^ICMJE

Principal Investigator:

Supenya varothai, M.D.

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

Information Provided By

Mahidol University

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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