WrinklesPhase 3NCT01381484
Argireline in Treatment of Periorbital Wrinkles
A Phase 3 study testing 10% Argireline in people with Wrinkles, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether La Jolie gel is effective in the treatment of periorbital wrinkles. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkles
- What is being tested?
- 10% Argireline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2009to Sep 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy woman at 35-45 years old
- Presence of periorbital wrinkles
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Thailand1 site
Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
About this study
Official title: Efficacy and Safety of Topical Argireline in the Treatment of Periorbital Wrinkles
The purpose of this study is to determine whether La Jolie gel is effective in the treatment of periorbital wrinkles.
Read the 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.
- Conditions
- Wrinkles
- Being tested
- 10% Argireline
- Keywords
- Periorbital wrinkles, Efficacy and safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% ArgirelineDrug
Also called 10% Argireline (La jolie gel®)
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | This group received placebo gel and requested to apply periorbital area and over the face for 3 months. |
| Study group | Experimental | This group received La Jolie Gel and requested to apply periorbital area and over the face for 3 months. Receives: Drug: 10% Argireline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
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
Measured: 3 months
Secondary outcomes (1)
Safety
Number of participants with adverse events Categorized adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for WrinklesStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Pacific Health Foundation
- Investigators
- Supenya varothai, M.D., Principal investigator, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381484
- Sponsor's protocol ID
- Svarothai
- Status last verified
- Mar 2011
- First submitted
- 30 Mar 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Blanes-Mira C, Clemente J, Jodas G, Gil A, Fernandez-Ballester G, Ponsati B, Gutierrez L, Perez-Paya E, Ferrer-Montiel A. A synthetic hexapeptide (Argireline) with antiwrinkle activity. Int J Cosmet Sci. 2002 Oct;24(5):303-10. doi: 10.1046/j.1467-2494.2002.00153.x.
PubMed 18498523Tokiwa Y, Kitagawa M, Raku T, Yanagitani S, Yoshino K. Enzymatic synthesis of arbutin undecylenic acid ester and its inhibitory effect on melanin synthesis. Bioorg Med Chem Lett. 2007 Jun 1;17(11):3105-8. doi: 10.1016/j.bmcl.2007.03.039. Epub 2007 Mar 16.
PubMed 17418566Farage MA, Miller KW, Elsner P, Maibach HI. Intrinsic and extrinsic factors in skin ageing: a review. Int J Cosmet Sci. 2008 Apr;30(2):87-95. doi: 10.1111/j.1468-2494.2007.00415.x.
PubMed 18377617Klein AW. Complications, adverse reactions, and insights with the use of botulinum toxin. Dermatol Surg. 2003 May;29(5):549-56; discussion 556. doi: 10.1046/j.1524-4725.2003.29129.x. No abstract available.
PubMed 12752527Brown MB, Jones SA. Hyaluronic acid: a unique topical vehicle for the localized delivery of drugs to the skin. J Eur Acad Dermatol Venereol. 2005 May;19(3):308-18. doi: 10.1111/j.1468-3083.2004.01180.x.
PubMed 15857456Abella ML. Evaluation of anti-wrinkle efficacy of adenosine-containing products using the FOITS technique. Int J Cosmet Sci. 2006 Dec;28(6):447-51. doi: 10.1111/j.1467-2494.2006.00349.x.
PubMed 18489289Senni K, Gueniche F, Foucault-Bertaud A, Igondjo-Tchen S, Fioretti F, Colliec-Jouault S, Durand P, Guezennec J, Godeau G, Letourneur D. Fucoidan a sulfated polysaccharide from brown algae is a potent modulator of connective tissue proteolysis. Arch Biochem Biophys. 2006 Jan 1;445(1):56-64. doi: 10.1016/j.abb.2005.11.001. Epub 2005 Nov 28.
PubMed 16364234Narins RS, Brandt F, Leyden J, Lorenc ZP, Rubin M, Smith S. A randomized, double-blind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol Surg. 2003 Jun;29(6):588-95. doi: 10.1046/j.1524-4725.2003.29150.x.
PubMed 12786700Rohrich RJ. The increasing popularity of cosmetic surgery procedures: a look at statistics in plastic surgery. Plast Reconstr Surg. 2000 Nov;106(6):1363-5. doi: 10.1097/00006534-200011000-00023. No abstract available.
PubMed 11083570Manaloto RM, Alster TS. Periorbital rejuvenation: a review of dermatologic treatments. Dermatol Surg. 1999 Jan;25(1):1-9. doi: 10.1046/j.1524-4725.1999.08049.x.
PubMed 9935084
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Argireline in the Treatment of Periorbital Wrinkles
- ClinicalTrials.gov ID
- NCT01381484
- Acronym / sponsor ID
- Svarothai
- Conditions
- Wrinkles
- Keywords
- Periorbital wrinkles, Efficacy and safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Pacific Health Foundation
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –This group received placebo gel and requested to apply periorbital area and over the face for 3 months. |
| Study group | Experimental | Drug: 10% ArgirelineThis group received La Jolie Gel and requested to apply periorbital area and over the face for 3 months. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy woman at 35-45 years old
- Presence of periorbital wrinkles
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% ArgirelineAlso: 10% Argireline (La jolie gel®)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. | Drug | Study group |
Primary outcome
Efficacy
Time frame: 3 months
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
1 secondary outcome
Safety
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
- Background: PubMed 18498523Blanes-Mira C, Clemente J, Jodas G, Gil A, Fernandez-Ballester G, Ponsati B, Gutierrez L, Perez-Paya E, Ferrer-Montiel A. A synthetic hexapeptide (Argireline) with antiwrinkle activity. Int J Cosmet Sci. 2002 Oct;24(5):303-10. doi: 10.1046/j.1467-2494.2002.00153.x.
- Background: PubMed 17418566Tokiwa Y, Kitagawa M, Raku T, Yanagitani S, Yoshino K. Enzymatic synthesis of arbutin undecylenic acid ester and its inhibitory effect on melanin synthesis. Bioorg Med Chem Lett. 2007 Jun 1;17(11):3105-8. doi: 10.1016/j.bmcl.2007.03.039. Epub 2007 Mar 16.
- Results publication: PubMed 18377617Farage MA, Miller KW, Elsner P, Maibach HI. Intrinsic and extrinsic factors in skin ageing: a review. Int J Cosmet Sci. 2008 Apr;30(2):87-95. doi: 10.1111/j.1468-2494.2007.00415.x.
- Results publication: PubMed 12752527Klein AW. Complications, adverse reactions, and insights with the use of botulinum toxin. Dermatol Surg. 2003 May;29(5):549-56; discussion 556. doi: 10.1046/j.1524-4725.2003.29129.x. No abstract available.
- Results publication: PubMed 15857456Brown MB, Jones SA. Hyaluronic acid: a unique topical vehicle for the localized delivery of drugs to the skin. J Eur Acad Dermatol Venereol. 2005 May;19(3):308-18. doi: 10.1111/j.1468-3083.2004.01180.x.
- Results publication: PubMed 18489289Abella ML. Evaluation of anti-wrinkle efficacy of adenosine-containing products using the FOITS technique. Int J Cosmet Sci. 2006 Dec;28(6):447-51. doi: 10.1111/j.1467-2494.2006.00349.x.
- Results publication: PubMed 16364234Senni K, Gueniche F, Foucault-Bertaud A, Igondjo-Tchen S, Fioretti F, Colliec-Jouault S, Durand P, Guezennec J, Godeau G, Letourneur D. Fucoidan a sulfated polysaccharide from brown algae is a potent modulator of connective tissue proteolysis. Arch Biochem Biophys. 2006 Jan 1;445(1):56-64. doi: 10.1016/j.abb.2005.11.001. Epub 2005 Nov 28.
- Results publication: PubMed 12786700Narins RS, Brandt F, Leyden J, Lorenc ZP, Rubin M, Smith S. A randomized, double-blind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol Surg. 2003 Jun;29(6):588-95. doi: 10.1046/j.1524-4725.2003.29150.x.
- Results publication: PubMed 11083570Rohrich RJ. The increasing popularity of cosmetic surgery procedures: a look at statistics in plastic surgery. Plast Reconstr Surg. 2000 Nov;106(6):1363-5. doi: 10.1097/00006534-200011000-00023. No abstract available.
- Results publication: PubMed 9935084Manaloto RM, Alster TS. Periorbital rejuvenation: a review of dermatologic treatments. Dermatol Surg. 1999 Jan;25(1):1-9. doi: 10.1046/j.1524-4725.1999.08049.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Supenya varothai, M.D. principal investigator
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10% Argireline in people with Wrinkles, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01381484, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.