Facial WrinklesPhase 1/2NCT00734786
Efficacy and Safety of a Cutaneous Formulation of Gonyautoxin 2/3 (GTX 2/3) for the Treatment of Facial Wrinkles
A Phase 1/2 study testing Wrinkle cream application in people with Facial Wrinkles, run by Phytotox SA at 1 site in Argentina.
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). Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles
- What is being tested?
- Wrinkle cream application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteArgentina
- Study dates
- Aug 2008to Sep 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read the 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.
- Conditions
- Facial Wrinkles
- Being tested
- Wrinkle cream application
- Keywords
- gonyautoxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrinkle cream applicationOther
Also called No other product will be used.
Single application on the crow's feet wrinkles. Placebo cream will be applied on one side, the active cream on the other side.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Wrinkle cream application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of facial wrinkles
Measured: 24 hours
Secondary outcomes (1)
Local and general tolerance
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2008 (estimated)
- Study completionSep 2008 (estimated)
Why it stopped: Study cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phytotox SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Silvia H Pérez-Damonte, PhD, Principal investigator, CLAIM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734786
- Sponsor's protocol ID
- CLN 08-003
- Status last verified
- Aug 2008
- First submitted
- 7 Aug 2008
- Last updated
- 25 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00734786
- Acronym / sponsor ID
- CLN 08-003
- Conditions
- Facial Wrinkles
- Keywords
- gonyautoxin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study cancelled.
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Phytotox SAIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Sep 2008 (estimated)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Other: Wrinkle cream applicationVolunteers will be their own control by randomly receiving the active on one face side and the placebo on the opposite one. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrinkle cream applicationAlso: No other product will be used.Single application on the crow's feet wrinkles. Placebo cream will be applied on one side, the active cream on the other side. | Other | 2 |
Primary outcome
Depth of facial wrinkles
Time frame: 24 hours
1 secondary outcome
Local and general tolerance
Time frame: 1day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia H Pérez-Damonte, PhD principal investigator
CLAIM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Wrinkle cream application in people with Facial Wrinkles, run by Phytotox SA at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depth of facial wrinkles (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2008.