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

NCT00736593 | Completed Phase 1 DMC

• 1 other identifier: NEX-SKI-001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Keywords

Wound; Healing

Outcome Measures

Primary Outcomes (1)

• Assessed by the incidence of adverse events from the time of application of the investigational product

  Until the end of the study.

Secondary Outcomes (4)

• 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

Study Arms (1)

1

EXPERIMENTAL

Drug: Nexagon™ or Nexagon™ vehicle

Interventions

Nexagon™ or Nexagon™ vehicle DRUG

1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OcuNexus Therapeutics, Inc.: lead

Study Sites (1)

Auckland Clinical Studies

Auckland, New Zealand

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Rod Ellis-Pegler

  Auckland Clinical Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 18, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 27, 2009

Record last verified: 2009-04

Locations

NZ (1)