Status:
COMPLETED
A Study Evaluating Nexagon™ in the Treatment of Skin Wounds.
Lead Sponsor:
OcuNexus Therapeutics, Inc.
Conditions:
Wound Healing
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00736593
Start Date
September 1 2008
End Date
April 1 2009
Last Update
April 27 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Auckland Clinical Studies
Auckland, New Zealand