Efficacy and Safety of a Cutaneous Formulation of Gonyautoxin 2/3 (GTX 2/3) for the Treatment of Facial Wrinkles
Phase 1
Withdrawn
- Conditions
- Facial Wrinkles
- Interventions
- Other: Wrinkle cream application
- Registration Number
- NCT00734786
- Lead Sponsor
- Phytotox SA
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- 15
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 2 Wrinkle cream application Volunteers will be their own control by randomly receiving the active on one face side and the placebo on the opposite one.
- Primary Outcome Measures
Name Time Method Depth of facial wrinkles 24 hours
- Secondary Outcome Measures
Name Time Method Local and general tolerance 1day
Trial Locations
- Locations (1)
CLAIM
🇦🇷Buenos Aires, CF, Argentina