NCT00713349CompletedPhase 2
A Randomized, Evaluator Blinded, Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing of Induced Thermal Wounds
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Healthpoint
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Complete Wound Closure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •Meet none of the exclusion criteria (any single exclusion criterion which is met by a potential subject will disqualify that subject from participation in this study).
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.
Arms & Interventions
2
Placebo Comparator
Placebo Comparator
Intervention: Placebo comparator (Other)
1
Other
Xenaderm Vehicle
Intervention: Xenaderm Vehicle (Drug)
Outcomes
Primary Outcomes
Complete Wound Closure
Time Frame: 21 Days
Each subject acting as their own control
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Cryocompression After Total Knee ArthroplastyCryotherapy EffectNCT05395273University of Applied Sciences and Arts of Southern Switzerland40
Suspended
Not Applicable
Assessment of Cryotherapy's Analgesic Impact in Anti-aromatase-induced ArthralgiaAromatase InhibitorsBreast CancerNCT05315011University Hospital, Montpellier70
Active, not recruiting
Phase 2
A Phase 2 Trial for Patients With Metastatic Solid CancerMetastatic CancerNCT04713371Rampart Health, L.L.C.32
Recruiting
Phase 2
The efficacy of two methods of cryotherapy with intralesional injection of Bloemycin in treatment of anogenital wartIRCT20190519043631N1Shahid Beheshti University of Medical Sciences60
Suspended
Not Applicable
Cryotherapy & OxaliplatinColon CancerPeripheral NeuropathyNCT06281925NYU Langone Health40