Efficacy and Safety of a Cutaneous Formulation of Gonyautoxin 2/3 (GTX 2/3) for the Treatment of Facial Wrinkles

Study Overview
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Brief Summary
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The main objective of the trial is to determine whether the current topical formulation of GTX 2/3 reduces the wrinkling of the skin (crow's feet) after a single application Other evaluation criteria include: safety assessment and local tolerance, depth of facial wrinkles (video microscopy imaging).

Detailed Description
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This is a single volunteer group study. Each volunteer will be her own control. A volunteer will receive the active product containing cream on one side of her face and will receive the placebo cream on the other side.

Official Title
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Efficacy and Safety of a Cutaneous Formulation of Gonyautoxin 2/3 (GTX 2/3) for the Treatment of Facial Wrinkles. Study # CLN 08-003.

Conditions
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Facial Wrinkles

Intervention / Treatment
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* Other: Wrinkle cream application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with no bearing-child potential or with adequate birth control method. Volunteers between 30 to 60 years of age. Subjects with bilateral crow's feet wrinkles. Regular user of cosmetic products, willing and able to comply with the study objectives. Signed informed consent. Exclusion Criteria: Any medical condition or any use of a medication that could modify the study results (e.g.: NSAIDs, immunosuppressant drugs, insulin...). Any other significant medical condition (e.g.: diabetes mellitus, heart disease, liver disease...). Any other condition that in the investigator's opinion could not be appropriate with the participation in this trial. Any health condition that could affect the evaluation of study parameters. Acute or chronic skin disease. History of allergic reaction to cosmetic compounds. Pregnancy, planned pregnancy or breast-feeding. Allergy to shellfish, fish or sea product (seaweed). Known or suspected hypersensitivity to any of the study product compounds. Participation in another clinical trial within 30 days previous to enrolment. Known or suspected alcohol or drug abuse.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>Volunteers will be their own control by randomly receiving the active on one face side and the placebo on the opposite one. | Other: Wrinkle cream application<br>* Single application on the crow's feet wrinkles. Placebo cream will be applied on one side, the active cream on the other side.<br>* Other names: No other product will be used.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth of facial wrinkles |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local and general tolerance |  | 1day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gonyautoxin