Efficacy and Safety of a Cutaneous Formulation of Gonyautoxin 2/3 (GTX 2/3) for the Treatment of Facial Wrinkles
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of a Cutaneous Formulation of Gonyautoxin 2/3 (GTX 2/3) for the Treatment of Facial Wrinkles. Study # CLN 08-003.|
- Depth of facial wrinkles [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Local and general tolerance [ Time Frame: 1day ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||September 2008|
|Estimated Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: 2
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
Single application on the crow's feet wrinkles. Placebo cream will be applied on one side, the active cream on the other side.
Other Name: No other product will be used.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734786
|Buenos Aires, CF, Argentina|
|Principal Investigator:||Silvia H Pérez-Damonte, PhD||CLAIM|