Wound HealingPhase 1NCT00736593
A Study Evaluating Nexagon™ in the Treatment of Skin Wounds.
A Phase 1 study of Wound Healing, run by OcuNexus Therapeutics, Inc. at 1 site in New Zealand.
Trial summary
Nexagon™ is a novel compound that promotes wound healing by temporarily disrupting cellular communication at the wound site, thereby promoting accelerated healing, reducing inflammation and pain. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Healing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteNew Zealand
- Study dates
- Sep 2008to Apr 2009
- Phase
- Phase 1
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects.
- Fair skinned (Fitzpatrick Classification Level I - III).
- Aged between 18 and 40 years inclusive.
- Subjects who are able to comply with all study procedures, including follow-up assessment visits.
- Subjects who are willing and able to give written informed consent to take part in the study.
Who cannot join
- Subjects who have pigmented skin due to an increased susceptibility to hypertrophic and keloid scarring (Fitzpatrick Classification Level IV - VI).
- Subjects who are known hypertrophic or keloid scar formers.
- Subjects who smoke.
- Subjects with a body mass index of greater than 30 kg/m2.
- Subjects with bleeding disorders or taking anti-coagulants.
- Subjects with any other skin lesion sites or a chronic or currently active skin disorder, which would adversely affect the healing of the acute wounds or which involve the areas to be examined in this study.
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- Subjects taking or who have taken prescribed drugs in the 30 days prior to Day 0, in particular, topical or systemic steroids, anti-inflammatories, anti-coagulants, anti-proliferative drugs, or antibiotics.
- Subjects who regularly take aspirin, ginseng, gilboa, Alka Seltzer or any other over-the-counter medicine or complimentary health product that can affect the blood clotting process.
- Subjects with a history of clinically relevant allergies.
- Subjects with tattoos, scars or abrasions at the site to be studied.
- Subjects with any clinically significant abnormality following review of pre-study laboratory data and physical examination.
- Subjects showing evidence of drug abuse.
- Subjects with any clinically significant mental illness in the opinion of the Investigator.
- Females who are currently pregnant or breast-feeding. Females of child-bearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined the protocol.
- Subjects who have a past or present disease, which as judged by the Investigator may affect the safety of the subject or the outcome of the study.
- Subjects who have participated in a clinical study within the 30 days prior to Day 0.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Prospective, Within-Subject, Double-Blind, Vehicle-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Clinical Effect of Nexagon™ in Full-Thickness Punch Wounds
Nexagon™ is a novel compound that promotes wound healing by temporarily disrupting cellular communication at the wound site, thereby promoting accelerated healing, reducing inflammation and pain. This randomized double-blind study will assess the safety, tolerability and clinical effect of Nexagon™ when applied to skin wounds created by punch biopsy in healthy volunteers. 43 healthy, fair-skinned males and females between ages 18-40 will be enrolled. Subjects will be reviewed again at 3 months and 9 months for follow-up safety assessments and wound appearance evaluation.
- Conditions
- Wound Healing
- Being tested
- Nexagon™ or Nexagon™ vehicle
- Keywords
- Wound, Healing
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexagon™ or Nexagon™ vehicleDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Nexagon™ or Nexagon™ vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessed by the incidence of adverse events from the time of application of the investigational product
Measured: Until the end of the study.
Secondary outcomes (4)
Time to complete closure of the wounds
Measured: 35 days post-application
Rate of healing
Measured: 35 days post application
Clinical assessment by rating scales
Measured: 35 days post application
Pain
Measured: 35 days post application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OcuNexus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rod Ellis-Pegler, Principal investigator, Auckland Clinical Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736593
- Sponsor's protocol ID
- NEX-SKI-001
- Status last verified
- Apr 2009
- First submitted
- 14 Aug 2008
- Last updated
- 27 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Prospective, Within-Subject, Double-Blind, Vehicle-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Clinical Effect of Nexagon™ in Full-Thickness Punch Wounds
- ClinicalTrials.gov ID
- NCT00736593
- Acronym / sponsor ID
- NEX-SKI-001
- Conditions
- Wound Healing
- Keywords
- Wound, Healing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- OcuNexus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 18 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.
Nexagon™ is a novel compound that promotes wound healing by temporarily disrupting cellular communication at the wound site, thereby promoting accelerated healing, reducing inflammation and pain. This randomized double-blind study will assess the safety, tolerability and clinical effect of Nexagon™ when applied to skin wounds created by punch biopsy in healthy volunteers. 43 healthy, fair-skinned males and females between ages 18-40 will be enrolled. Subjects will be reviewed again at 3 months and 9 months for follow-up safety assessments and wound appearance evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nexagon™ or Nexagon™ vehicle |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects.
- Fair skinned (Fitzpatrick Classification Level I - III).
- Aged between 18 and 40 years inclusive.
- Subjects who are able to comply with all study procedures, including follow-up assessment visits.
- Subjects who are willing and able to give written informed consent to take part in the study.
Key exclusion criteria (16 listed)
- Subjects who have pigmented skin due to an increased susceptibility to hypertrophic and keloid scarring (Fitzpatrick Classification Level IV - VI).
- Subjects who are known hypertrophic or keloid scar formers.
- Subjects who smoke.
- Subjects with a body mass index of greater than 30 kg/m2.
- Subjects with bleeding disorders or taking anti-coagulants.
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 |
|---|---|---|
| Nexagon™ or Nexagon™ vehicle | Drug | 1 |
Primary outcome
Assessed by the incidence of adverse events from the time of application of the investigational product
Time frame: Until the end of the study.
4 secondary outcomes
Time to complete closure of the wounds
Time frame: 35 days post-application
Rate of healing
Time frame: 35 days post application
Clinical assessment by rating scales
Time frame: 35 days post application
Pain
Time frame: 35 days post application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2009.
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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.
Rod Ellis-Pegler principal investigator
Auckland Clinical Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Wound Healing, run by OcuNexus Therapeutics, Inc. at 1 site in New Zealand.
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 16 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: finished, as of the sponsor's last update on 27 Apr 2009. 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 New Zealand. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessed by the incidence of adverse events from the time of application of the investigational product (time frame: Until the end of the study.). 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 27 Apr 2009.