Argireline in Treatment of Periorbital Wrinkles

Mahidol University

Status and phase: Completed; Phase 3

Conditions: Wrinkles

Treatments: Drug: 10% Argireline

Study type: Interventional

Funder types: Other

Identifiers

NCT01381484

Svarothai

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 35 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Placebo

No Intervention group

Description:

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

Study group

Experimental group

Description:

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

Treatment:

Drug: 10% Argireline