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

This study has been completed.
Sponsor:
Information provided by:
CoDa Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00736593
First received: August 14, 2008
Last updated: April 23, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Wound Healing
 Drug: Nexagon™ or Nexagon™ vehicle
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by CoDa Therapeutics Inc.:

Primary Outcome Measures:
  • Assessed by the incidence of adverse events from the time of application of the investigational product [ Time Frame: Until the end of the study. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to complete closure of the wounds [ Time Frame: 35 days post-application ] [ Designated as safety issue: No ]
  • Rate of healing [ Time Frame: 35 days post application ] [ Designated as safety issue: No ]
  • Clinical assessment by rating scales [ Time Frame: 35 days post application ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 35 days post application ] [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: September 2008
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Nexagon™ or Nexagon™ vehicle

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736593

Locations
New Zealand
Auckland Clinical Studies
Auckland, New Zealand
Sponsors and Collaborators
CoDa Therapeutics Inc.
Investigators
Principal Investigator: Rod Ellis-Pegler Auckland Clinical Studies
  More Information

No publications provided

Responsible Party: Alexis White, CoDaTherapeutics
ClinicalTrials.gov Identifier: NCT00736593     History of Changes
Other Study ID Numbers: NEX-SKI-001
Study First Received: August 14, 2008
Last Updated: April 23, 2009
Health Authority: New Zealand: Medsafe

Keywords provided by CoDa Therapeutics Inc.:
Wound
Healing

ClinicalTrials.gov processed this record on June 18, 2013