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

August 22, 2008 updated by: Phytotox SA

Efficacy and Safety of a Cutaneous Formulation of Gonyautoxin 2/3 (GTX 2/3) for the Treatment of Facial Wrinkles. Study # CLN 08-003.

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • CF
      • Buenos Aires, CF, Argentina
        • CLAIM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • No other product will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depth of facial wrinkles
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Local and general tolerance
Time Frame: 1day
1day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phytotox SA

Investigators

  • Principal Investigator: Silvia H Pérez-Damonte, PhD, CLAIM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ANTICIPATED)

September 1, 2008

Study Completion (ANTICIPATED)

September 1, 2008

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (ESTIMATE)

August 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 25, 2008

Last Update Submitted That Met QC Criteria

August 22, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN 08-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Facial Wrinkles

Clinical Trials on Wrinkle cream application

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe