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.