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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
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

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
Timepoint [4] 0 0
35 days post application

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
Minimum age
18 Years
Maximum age
40 Years
Both males and females
Can healthy volunteers participate?
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

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
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 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0

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

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

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
Other publications