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

Facial Wrinkles Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00734786
• Other study ID #: CLN 08-003
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: August 7, 2008
• Last updated: August 22, 2008
• Start date: August 2008
• Est. completion date: September 2008

Study information

• Verified date: August 2008
• Source: Phytotox SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 15
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Wrinkles
• Facies

Intervention

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.

Locations

Country	Name	City	State
Argentina	CLAIM	Buenos Aires	CF

Sponsors (1)

Lead Sponsor	Collaborator
Phytotox SA

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depth of facial wrinkles		24 hours	No
Secondary	Local and general tolerance		1day	Yes