Argireline in Treatment of Periorbital Wrinkles
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Topical Argireline in the Treatment of Periorbital Wrinkles|
- Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]Number of participants with adverse events Categorized adverse events
|Study Start Date:||March 2009|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
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®)
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|