Healthy
Conditions
Keywords
wound healing, phototoxicity, Healthy Subjects
Brief summary
The product is being tested to see if exposure to light causes toxic reactions on the skin.
Interventions
DRUGXenaderm
20mg under Finn chambers
DRUGPlacebo
20mg under Finn chambers
Sponsors
Healthpoint
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects
Exclusion criteria
* Under 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Reaction Score | 48 hours | Scores for phototoxic skin irritation were used to evaluate safety. In this study, irritation was graded using a scale that ranged from 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. |
Participant flow
Recruitment details
This phase 1 study was conducted at one investigational site (Research Laboratory) located in the US, and conducted on healthy adult subjects of either gender, and skin-type I, II, or III, who were 18 years of age and older, from 19-Feb-2008 to 29-Feb-2008.
Participants by arm
| Arm | Count |
|---|---|
| Xenaderm vs. Vehicle - Subjects Acted as Own Comparator Subjects received duplicate 20 mg applications of Xenaderm Ointment and Xenaderm vehicle contained in Finn Chambers, to the left sides of their backs | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Xenaderm vs. Vehicle - Subjects Acted as Own Comparator |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants |
| Age, Continuous | 37.5 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Skin Reaction Score
Scores for phototoxic skin irritation were used to evaluate safety. In this study, irritation was graded using a scale that ranged from 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units.
Time frame: 48 hours
Population: Intent-to-Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Xenaderm Ointment - Irradiated | Skin Reaction Score | Day 2 at patch removal | 0.4 units on a scale | Standard Deviation 0.5 |
| Xenaderm Ointment - Irradiated | Skin Reaction Score | Day 4 - 48 hours post UV radiation | 0.4 units on a scale | Standard Deviation 0.8 |
| Xenaderm Ointment - Irradiated | Skin Reaction Score | Day 3 - 24 hours post UV radiation | 0.5 units on a scale | Standard Deviation 1 |
| Xenaderm Ointment - Irradiated | Skin Reaction Score | Day 2 immediately post UV radiation | 0.3 units on a scale | Standard Deviation 0.6 |
| Xenaderm Vehicle - Irradiated | Skin Reaction Score | Day 4 - 48 hours post UV radiation | 0.6 units on a scale | Standard Deviation 1 |
| Xenaderm Vehicle - Irradiated | Skin Reaction Score | Day 2 immediately post UV radiation | 0.7 units on a scale | Standard Deviation 0.9 |
| Xenaderm Vehicle - Irradiated | Skin Reaction Score | Day 2 at patch removal | 0.5 units on a scale | Standard Deviation 0.6 |
| Xenaderm Vehicle - Irradiated | Skin Reaction Score | Day 3 - 24 hours post UV radiation | 0.8 units on a scale | Standard Deviation 1.1 |
| Control - Irradiated | Skin Reaction Score | Day 2 immediately post UV radiation | 0.5 units on a scale | Standard Deviation 0.8 |
| Control - Irradiated | Skin Reaction Score | Day 2 at patch removal | 0.1 units on a scale | Standard Deviation 0.2 |
| Control - Irradiated | Skin Reaction Score | Day 4 - 48 hours post UV radiation | 0.7 units on a scale | Standard Deviation 1.1 |
| Control - Irradiated | Skin Reaction Score | Day 3 - 24 hours post UV radiation | 0.9 units on a scale | Standard Deviation 1.1 |
| Xenaderm Ointment - Non-irradiated | Skin Reaction Score | Day 3 - 24 hours post UV radiation | 0.3 units on a scale | Standard Deviation 0.6 |
| Xenaderm Ointment - Non-irradiated | Skin Reaction Score | Day 2 immediately post UV radiation | 0.2 units on a scale | Standard Deviation 0.5 |
| Xenaderm Ointment - Non-irradiated | Skin Reaction Score | Day 2 at patch removal | 0.4 units on a scale | Standard Deviation 0.5 |
| Xenaderm Ointment - Non-irradiated | Skin Reaction Score | Day 4 - 48 hours post UV radiation | 0.2 units on a scale | Standard Deviation 0.5 |
| Xenaderm Vehicle - Non-irradiated | Skin Reaction Score | Day 4 - 48 hours post UV radiation | 0.2 units on a scale | Standard Deviation 0.5 |
| Xenaderm Vehicle - Non-irradiated | Skin Reaction Score | Day 2 at patch removal | 0.5 units on a scale | Standard Deviation 0.6 |
| Xenaderm Vehicle - Non-irradiated | Skin Reaction Score | Day 2 immediately post UV radiation | 0.4 units on a scale | Standard Deviation 0.6 |
| Xenaderm Vehicle - Non-irradiated | Skin Reaction Score | Day 3 - 24 hours post UV radiation | 0.2 units on a scale | Standard Deviation 0.4 |