Back to resultsA Study Evaluating Nexagon™ in the Treatment of Skin Wounds.
Primary Purpose
Wound Healing
Status
Completed
Phase
Phase 1
Locations
New Zealand
Study Type
Interventional
Intervention
Nexagon™ or Nexagon™ vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Wound Healing focused on measuring Wound, Healing
Eligibility Criteria
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.
Sites / Locations
- Auckland Clinical Studies
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Assessed by the incidence of adverse events from the time of application of the investigational product
Secondary Outcome Measures
Time to complete closure of the wounds
Rate of healing
Clinical assessment by rating scales
Pain
Full Information
NCT ID
NCT00736593
First Posted
August 14, 2008
Last Updated
April 23, 2009
Sponsor
OcuNexus Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00736593
Brief Title
A Study Evaluating Nexagon™ in the Treatment of Skin Wounds.
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 Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
OcuNexus Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing
Keywords
Wound, Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nexagon™ or Nexagon™ vehicle
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Time to complete closure of the wounds
Time Frame
35 days post-application
Title
Rate of healing
Time Frame
35 days post application
Title
Clinical assessment by rating scales
Time Frame
35 days post application
Title
Pain
Time Frame
35 days post application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rod Ellis-Pegler
Organizational Affiliation
Auckland Clinical Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auckland Clinical Studies
City
Auckland
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating Nexagon™ in the Treatment of Skin Wounds.
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