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

Phytotox SA

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Facial Wrinkles

Treatments

Other: Wrinkle cream application

Study type

Interventional

Funder types

Industry

Identifiers

NCT00734786

CLN 08-003

Details and patient eligibility

About

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).

Full 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.

Enrollment

15 estimated patients

Sex

Female

Ages

30 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.