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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00736593




Registration number
NCT00736593
Ethics application status
Date submitted
14/08/2008
Date registered
18/08/2008
Date last updated
27/04/2009

Titles & IDs
Public title
A Study Evaluating Nexagon™ in the Treatment of Skin Wounds.
Scientific 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
Secondary ID [1] 0 0
NEX-SKI-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound Healing 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nexagon™ or Nexagon™ vehicle

Experimental: 1 -


Treatment: Drugs: Nexagon™ or Nexagon™ vehicle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assessed by the incidence of adverse events from the time of application of the investigational product
Timepoint [1] 0 0
Until the end of the study.
Secondary outcome [1] 0 0
Time to complete closure of the wounds
Timepoint [1] 0 0
35 days post-application
Secondary outcome [2] 0 0
Rate of healing
Timepoint [2] 0 0
35 days post application
Secondary outcome [3] 0 0
Clinical assessment by rating scales
Timepoint [3] 0 0
35 days post application
Secondary outcome [4] 0 0
Pain
Timepoint [4] 0 0
35 days post application

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
43
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
OcuNexus Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00736593
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rod Ellis-Pegler
Address 0 0
Auckland Clinical Studies
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00736593