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Sponsored by: |
Phytotox SA |
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Information provided by: | Phytotox SA |
ClinicalTrials.gov Identifier: | NCT00734786 |
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).
Condition | Intervention | Phase |
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Facial Wrinkles |
Other: Wrinkle cream application |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 15 |
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) |
Arms | Assigned Interventions |
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2: Placebo Comparator
Volunteers will be their own control by randomly receiving the active on one face side and the placebo on the opposite one.
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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.
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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.
Ages Eligible for Study: | 30 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | CLAIM ( Dra Silvia Pérez Damonte ) |
Study ID Numbers: | CLN 08-003 |
Study First Received: | August 7, 2008 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00734786 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
gonyautoxin |
Facies |
Disease Attributes Pathologic Processes |