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OpenTrials
Completed

NCT Number: NCT00736593

A Study Evaluating Nexagon™ in the Treatment of Skin 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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Auckland Clinical Studies

Auckland, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Nexagon™ or Nexagon™ vehicle

Drug

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

Sponsors and collaborators

Lead sponsor

OcuNexus Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 18, 2008
Registry last updated
Apr 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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