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

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

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.

Study Overview

• Status: Completed
• Conditions: Wound Healing
• Intervention / Treatment: Drug: Nexagon™ or Nexagon™ vehicle

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • Auckland Clinical Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Nexagon™ or Nexagon™ vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessed by the incidence of adverse events from the time of application of the investigational product	Until the end of the study.

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to complete closure of the wounds	35 days post-application
Rate of healing	35 days post application
Clinical assessment by rating scales	35 days post application
Pain	35 days post application

Collaborators and Investigators

• Sponsor: OcuNexus Therapeutics, Inc.
• Investigators: Principal Investigator: Rod Ellis-Pegler, Auckland Clinical Studies

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: August 14, 2008
• First Submitted That Met QC Criteria: August 15, 2008
• First Posted (Estimate): August 18, 2008

Study Record Updates

• Last Update Posted (Estimate): April 27, 2009
• Last Update Submitted That Met QC Criteria: April 23, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Wound; Healing
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: NEX-SKI-001