Status:
WITHDRAWN
Efficacy and Safety of a Cutaneous Formulation of Gonyautoxin 2/3 (GTX 2/3) for the Treatment of Facial Wrinkles
Lead Sponsor:
Phytotox SA
Conditions:
Facial Wrinkles
Eligibility:
FEMALE
30-60 years
Phase:
PHASE1
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00734786
Start Date
August 1 2008
End Date
September 1 2008
Last Update
August 25 2008
Active Locations (1)
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1
CLAIM
Buenos Aires, Buenos Aires F.D., Argentina