NCT00713349

Brief Summary

The objective of the study is to compare the healing of wounds induced by cryo-injury when treated with white petrolatum versus an ointment vehicle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

December 6, 2013

Completed
Last Updated

December 6, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

July 9, 2008

Results QC Date

October 9, 2013

Last Update Submit

October 9, 2013

Conditions

Wounds

Keywords

WhitePetrolatumXenadermVehiclePartial thickness woundsHealingCryo-surgery

Outcome Measures

Primary Outcomes (1)

  • Complete Wound Closure

    Each subject acting as their own control

    21 Days

Study Arms (2)

1

OTHER

Xenaderm Vehicle

Drug: Xenaderm Vehicle

2

PLACEBO COMPARATOR

Placebo Comparator

Other: Placebo comparator

Interventions

Xenaderm VehicleDRUG

Ointment to be applied three times a day on cryo-surgery wound for 21 days.

Also known as: Subject acts as own control
1
Placebo comparatorOTHER

Ointment to be applied three times a day on cryo-surgery wound for 21 days.

Also known as: Subject acts as own control
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be considered qualified for enrollment if they:
  • Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks and contact information.
  • Are male or female, ≥ 18 years of age, of any race.
  • Are willing to attend all required study visits, and to comply with study procedures.

You may not qualify if:

  • Subjects will be considered NOT qualified for enrollment if they:
  • Have a history of dermatomyositis, systemic sclerosis, scleroderma, Sjögren's syndrome, systemic lupus erythematosis, discoid lupus, Ehler's Danlos disease, icthyosis vulgaris, vasculitis or bleeding disorders (coagulopathies).
  • Have any dermatologic disease which may be aggravated or provoked by the wounding procedure, such as Lichen Planus, Psoriasis or Vitiligo.
  • Have Fitzpatrick scale skin type 6 (never sunburns, deeply pigmented).
  • Are at risk of keloid or hypertrophic scar formation, based on personal history, family history, or brief skin exam (conducted at the screening visit to look for keloids or hypertrophic scars).
  • Have been treated within the last three months for uncontrolled diabetes mellitus, peripheral vascular disease, vitamin C deficiency, connective tissue disorders, or any other disease process that impedes wound healing.
  • Are taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs.
  • Are using topical glycolic acid products, alpha-hydroxy acid products, retinoids or chemical peel agents in the treatment areas.
  • Are using systemic steroids or immunosuppressant agents, or have used these drugs within the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Dermatology, Wake Forrest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Granulex

Results Point of Contact

Title
Jaime Dickerson, PhD
Organization
Smith & Nephew Biotherapeutics
jaime.dickerson@smith-nephew.com
817-302-3914

Study Officials

  • Herbert R Slade, MD

    Healthpoint

    STUDY CHAIR

  • D. Innes Cargill, PhD

    Healthpoint

    STUDY DIRECTOR

  • Steven R Feldman, MD, PhD

    Wake Forest

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 11, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2008

Study Completion

September 1, 2008

Last Updated

December 6, 2013

Results First Posted

December 6, 2013

Record last verified: 2013-10

Locations

US(1)