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

NCT00734786 | Withdrawn Phase 1

• 1 other identifier: CLN 08-003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Facial Wrinkles

Keywords

gonyautoxin

Outcome Measures

Primary Outcomes (1)

• Depth of facial wrinkles

  24 hours

Secondary Outcomes (1)

• Local and general tolerance

  1day

Study Arms (1)

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

Interventions

Wrinkle cream application OTHER

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

Also known as: No other product will be used.

2

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Phytotox SA: lead

Study Sites (1)

CLAIM

Buenos Aires, Buenos Aires F.D., Argentina

Location

Study Officials

• Silvia H Pérez-Damonte, PhD

  CLAIM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 14, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 25, 2008

Record last verified: 2008-08

Locations

AR (1)