Efficacy and Safety of a Cutaneous Formulation of Gonyautoxin 2/3 (GTX 2/3) for the Treatment of Facial Wrinkles

This study has been withdrawn prior to enrollment.
(Study cancelled.)
Sponsor:
Information provided by:
Phytotox SA
ClinicalTrials.gov Identifier:
NCT00734786
First received: August 7, 2008
Last updated: August 22, 2008
Last verified: August 2008
  Purpose

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
Facial Wrinkles
Other: Wrinkle cream application
Phase 1
Phase 2

Study Type: Interventional
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.

Further study details as provided by Phytotox SA:

Primary Outcome Measures:
  • Depth of facial wrinkles [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local and general tolerance [ Time Frame: 1day ] [ Designated as safety issue: Yes ]

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
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.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734786

Locations
Argentina
CLAIM
Buenos Aires, CF, Argentina
Sponsors and Collaborators
Phytotox SA
Investigators
Principal Investigator: Silvia H Pérez-Damonte, PhD CLAIM
  More Information

No publications provided

Responsible Party: Dra Silvia Pérez Damonte, CLAIM
ClinicalTrials.gov Identifier: NCT00734786     History of Changes
Other Study ID Numbers: CLN 08-003
Study First Received: August 7, 2008
Last Updated: August 22, 2008
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Phytotox SA:
gonyautoxin

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014