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

Wound Healing Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736593
• Other study ID #: NEX-SKI-001
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2008
• Last updated: April 23, 2009
• Start date: September 2008
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: CoDa Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Medsafe
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Wound Healing

Intervention

Drug:
• Nexagon™ or Nexagon™ vehicle

Locations

Country	Name	City	State
New Zealand	Auckland Clinical Studies	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
CoDa Therapeutics Inc.

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessed by the incidence of adverse events from the time of application of the investigational product		Until the end of the study.	Yes
Secondary	Time to complete closure of the wounds		35 days post-application	No
Secondary	Rate of healing		35 days post application	No
Secondary	Clinical assessment by rating scales		35 days post application	No
Secondary	Pain		35 days post application	No