Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing

NCT ID: NCT00713349

Last Updated: 2013-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2008-09-30

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.

Conditions

Wounds

Keywords

White; Petrolatum; Xenaderm; Vehicle; Partial thickness wounds; Healing; Cryo-surgery

Study Design

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

Study Groups

1

Xenaderm Vehicle

Group Type: OTHER

Xenaderm Vehicle

Intervention Type: DRUG

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

2

Placebo Comparator

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: OTHER

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

Interventions

Xenaderm Vehicle

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

Intervention Type: DRUG

Placebo comparator

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

Intervention Type: OTHER

Other Intervention Names

Subject acts as own control; Subject acts as own control

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

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

Sponsors

Healthpoint

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert R Slade, MD

Role: STUDY_CHAIR

Healthpoint

D. Innes Cargill, PhD

Role: STUDY_DIRECTOR

Healthpoint

Steven R Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest

Locations

Dept. of Dermatology, Wake Forrest School of Medicine

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

011-101-09-004

Identifier Type: -

Identifier Source: org_study_id

NCT00693810

Identifier Type: -

Identifier Source: nct_alias