Healthy
Conditions
Keywords
wound healing, photoallergenicity, Healthy subjects
Brief summary
The product is being tested to see if exposure to light causes photoallergic reactions on the skin.
Interventions
OTHEROintment Vehicle
Subject acts as own control. 20 mg under Finn chambers
DRUGXenaderm
20 mg under Finn chambers
Sponsors
Healthpoint
Study design
Allocation
NA
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
* Less than 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency Distribution of Skin Irritation Scores | 48-hours post irradiation | Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. Photoallergic reactions were characterized by irritation scores of 3 or higher. |
Countries
United States
Participant flow
Recruitment details
Planned: Approximately 60 evaluable subjects. Analyzed: 59 subjects were enrolled in the study, of which 58 were randomized and received test article. 7 subjects were prematurely withdrawn - 1 prior to receiving test articles; 52 subjects completed the study and were evaluable.
Participants by arm
| Arm | Count |
|---|---|
| Xenaderm Subject serves as own control | 59 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Xenaderm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants |
| Age Continuous | 38.8 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment United States | 59 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / — |
| serious Total, serious adverse events | 0 / 59 |
Outcome results
Primary
Frequency Distribution of Skin Irritation Scores
Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. Photoallergic reactions were characterized by irritation scores of 3 or higher.
Time frame: 48-hours post irradiation
Population: Analysis was based on number of subjects who completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Xenaderm | Frequency Distribution of Skin Irritation Scores | Large vesiculo-bullous reaction (7) | 0 Scores on a scale |
| Xenaderm | Frequency Distribution of Skin Irritation Scores | No reaction (0) | 39 Scores on a scale |
| Xenaderm | Frequency Distribution of Skin Irritation Scores | Minimal (doubtful) response (1) | 10 Scores on a scale |
| Xenaderm | Frequency Distribution of Skin Irritation Scores | Definite, mild erythema (2) | 3 Scores on a scale |
| Xenaderm | Frequency Distribution of Skin Irritation Scores | Moderate erythema (3) | 0 Scores on a scale |
| Xenaderm | Frequency Distribution of Skin Irritation Scores | Erythema with slight edema (4) | 0 Scores on a scale |
| Xenaderm | Frequency Distribution of Skin Irritation Scores | Erythema with marked edema (5) | 0 Scores on a scale |
| Xenaderm | Frequency Distribution of Skin Irritation Scores | Erythema w/infiltration w/wo vesiculation (6) | 0 Scores on a scale |