MedDataX Logo

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

NCT ID: NCT00734786

Last Updated: 2008-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Facial Wrinkles

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

gonyautoxin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2

Volunteers will be their own control by randomly receiving the active on one face side and the placebo on the opposite one.

Group Type PLACEBO_COMPARATOR

Wrinkle cream application

Intervention Type OTHER

Single application on the crow's feet wrinkles. Placebo cream will be applied on one side, the active cream on the other side.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

No other product will be used.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Phytotox SA

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

CLAIM

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Silvia H Pérez-Damonte, PhD

Role: PRINCIPAL_INVESTIGATOR

CLAIM

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CLAIM

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Argentina

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLN 08-003

Identifier Type: -

Identifier Source: org_study_id