Wounds
Conditions
Keywords
White, Petrolatum, Xenaderm, Vehicle, Partial thickness wounds, Healing, Cryo-surgery
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.
Interventions
DRUGXenaderm Vehicle
Ointment to be applied three times a day on cryo-surgery wound for 21 days.
OTHERPlacebo comparator
Ointment to be applied three times a day on cryo-surgery wound for 21 days.
Sponsors
Healthpoint
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Wound Closure | 21 Days | Each subject acting as their own control |
Countries
United States
Participant flow
Recruitment details
Healthy adult volunteers, 18 years of age and older
Pre-assignment details
Each subject acting as their own control
Participants by arm
| Arm | Count |
|---|---|
| Vehicle vs. Placebo Xenaderm Vehicle and White Petrolatum as Placebo Comparator
Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.
White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days
Each subject acting as their own control | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Vehicle vs. Placebo |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age Continuous | 43 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 25 | 6 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Complete Wound Closure
Each subject acting as their own control
Time frame: 21 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Complete Wound Closure | 14.8 days | Standard Deviation 1.1 |
| Placebo Control | Complete Wound Closure | 14.9 days | Standard Deviation 1.3 |