Clinical trial NCT01381484: Argireline in Treatment of Periorbital Wrinkles
Official title: Efficacy and Safety of Topical Argireline in the Treatment of Periorbital Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wrinkles
Keywords: Periorbital wrinkles
Efficacy and safety
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Pacific Health Foundation
First posted: 2011-06-27
Enrollment: 70
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Efficacy
timeFrame: 3 months
Secondary outcomes:
measure: Safety
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Supenya varothai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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