Facial Wrinkles
Conditions
Keywords
gonyautoxin
Brief summary
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
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.
Interventions
OTHERWrinkle cream application
Single application on the crow's feet wrinkles. Placebo cream will be applied on one side, the active cream on the other side.
Sponsors
Phytotox SA
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depth of facial wrinkles | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Local and general tolerance | 1day |
Countries
Argentina
Outcome results
None listed