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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00736593
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : April 27, 2009
Information provided by:
CoDa Therapeutics Inc.

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, 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
Study Start Date : September 2008
Primary Completion Date : January 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Nexagon™ or Nexagon™ vehicle

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00736593

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

Responsible Party: Alexis White, CoDaTherapeutics Identifier: NCT00736593     History of Changes
Other Study ID Numbers: NEX-SKI-001
First Posted: August 18, 2008    Key Record Dates
Last Update Posted: April 27, 2009
Last Verified: April 2009

Keywords provided by CoDa Therapeutics Inc.:

Additional relevant MeSH terms:
Wounds and Injuries