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

NCT ID: NCT00736593

Last Updated: 2009-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-04-30

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.

Conditions

Wound Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: EXPERIMENTAL

Nexagon™ or Nexagon™ vehicle

Intervention Type: DRUG

Interventions

Nexagon™ or Nexagon™ vehicle

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

OcuNexus Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

CoDaTherapeutics

Principal Investigators

Rod Ellis-Pegler

Role: PRINCIPAL_INVESTIGATOR

Auckland Clinical Studies

Locations

Auckland Clinical Studies

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

NEX-SKI-001

Identifier Type: -

Identifier Source: org_study_id