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

Sponsored by:	Phytotox SA
Information provided by:	Phytotox SA
ClinicalTrials.gov Identifier:	NCT00734786

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 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.

Resource links provided by NLM:

Drug Information available for: Gonyautoxin

U.S. FDA Resources

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
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.	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.

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

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

Locations

Argentina, CF
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:	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 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Phytotox SA:

gonyautoxin

Study placed in the following topic categories:

Facies

ClinicalTrials.gov processed this record on September 04, 2009