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CompletedNCT00736593Updated Apr 27, 2009

A Study Evaluating Nexagon™ in the Treatment of Skin Wounds.

A Phase 1 interventional study of Nexagon™ or Nexagon™ vehicle in Wound Healing, sponsored by OcuNexus Therapeutics, Inc.. Completed at 1 site in New Zealand. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-04-27.

Sponsored by OcuNexus Therapeutics, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Wound Healing

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Keywords

  • Wound
  • Healing
03

In context

Wounds and Injuries

5,085 studies on the registry are indexed under Wounds and Injuries; 849 are open to participants now.

This study's planned enrollment of 43 is below the median of 52 across 3,261 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

OcuNexus Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy male or female subjects.
  2. Fair skinned (Fitzpatrick Classification Level I - III).
  3. Aged between 18 and 40 years inclusive.
  4. Subjects who are able to comply with all study procedures, including follow-up assessment visits.
  5. Subjects who are willing and able to give written informed consent to take part in the study.

Exclusion criteria

Exclusion Criteria:

  1. Subjects who have pigmented skin due to an increased susceptibility to hypertrophic and keloid scarring (Fitzpatrick Classification Level IV - VI).
  2. Subjects who are known hypertrophic or keloid scar formers.
  3. Subjects who smoke.
  4. Subjects with a body mass index of greater than 30 kg/m2.
  5. Subjects with bleeding disorders or taking anti-coagulants.
  6. 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.
  7. 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.
  8. 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.
  9. Subjects with a history of clinically relevant allergies.
  10. Subjects with tattoos, scars or abrasions at the site to be studied.
  11. Subjects with any clinically significant abnormality following review of pre-study laboratory data and physical examination.
  12. Subjects showing evidence of drug abuse.
  13. Subjects with any clinically significant mental illness in the opinion of the Investigator.
  14. 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.
  15. 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.
  16. Subjects who have participated in a clinical study within the 30 days prior to Day 0.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
43 participants (estimated)

Study arms

  • Experimental
    1

    Drug: Nexagon™ or Nexagon™ vehicle

Interventions

  • DrugNexagon™ or Nexagon™ vehicle
06

What researchers measure

Primary outcomes

  1. Assessed by the incidence of adverse events from the time of application of the investigational product

    Time frame: Until the end of the study.

Secondary outcomes

  1. Time to complete closure of the wounds

    Time frame: 35 days post-application

  2. Rate of healing

    Time frame: 35 days post application

  3. Clinical assessment by rating scales

    Time frame: 35 days post application

  4. Pain

    Time frame: 35 days post application

07

Study locations

1 site
  • Auckland Clinical Studies
    Auckland, New Zealand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00736593
Lead sponsor
OcuNexus Therapeutics, Inc.
First posted
Aug 18, 2008
Start date
Sep 2008
Primary completion
Jan 2009
Completion
Apr 2009
Last update
Apr 27, 2009

Study contacts

Rod Ellis-Pegler
principal investigator · Auckland Clinical Studies

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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