Argireline in Treatment of Periorbital Wrinkles
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|ClinicalTrials.gov Identifier: NCT01381484|
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
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|Condition or disease||Intervention/treatment||Phase|
|Wrinkles||Drug: 10% Argireline||Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy and Safety of Topical Argireline in the Treatment of Periorbital Wrinkles|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
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®)
- Efficacy [ Time Frame: 3 months ]
- Noninvasive measurement by skin bioengineering technique e.g. visioscan, corneometer, cutometer
- Comparative photographic evaluation by certified dermatologists
- Patient Self assessment satifaction review
- Safety [ Time Frame: 3 months ]Number of participants with adverse events Categorized adverse events
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|Ages Eligible for Study:||35 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- healthy woman at 35-45 years old
- Presence of periorbital wrinkles
- 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)
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
|Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University|
|Bangkoknoi, Bangkok, Thailand, 10700|
|Principal Investigator:||Supenya varothai, M.D.||Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University|
|Responsible Party:||Department of dermatology, Mahidol university|
|Other Study ID Numbers:||
|First Posted:||June 27, 2011 Key Record Dates|
|Last Update Posted:||June 27, 2011|
|Last Verified:||March 2011|
Efficacy and safety