A Phase 1 interventional study of Xenaderm and Placebo in Healthy, sponsored by Healthpoint. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-13.
Sponsored by Healthpoint · Phase 1 and Interventional
The product is being tested to see if exposure to light causes toxic reactions on the skin.
Healthpoint is the lead sponsor of 33 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug
Drug: Xenaderm
Placebo comparator
Drug: Placebo
Subjects serve as own controls.
20mg under Finn chambers
20mg under Finn chambers
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
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.
| Milestone | Xenaderm Ointment - Subjects Acted as Own Comparator |
|---|---|
| Started | 38 |
| Completed | 36 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
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.
| units on a scale | Xenaderm Ointment - Irradiated | Xenaderm Vehicle - Irradiated | Control - Irradiated | Xenaderm Ointment - Non-irradiated | Xenaderm Vehicle - Non-irradiated |
|---|---|---|---|---|---|
| Day 2 at patch removal | 0.4 ± 0.5 | 0.5 ± 0.6 | 0.1 ± 0.2 | 0.4 ± 0.5 | 0.5 ± 0.6 |
| Day 2 immediately post UV radiation | 0.3 ± 0.6 | 0.7 ± 0.9 | 0.5 ± 0.8 | 0.2 ± 0.5 | 0.4 ± 0.6 |
| Day 3 - 24 hours post UV radiation | 0.5 ± 1.0 | 0.8 ± 1.1 | 0.9 ± 1.1 | 0.3 ± 0.6 | 0.2 ± 0.4 |
| Day 4 - 48 hours post UV radiation | 0.4 ± 0.8 | 0.6 ± 1.0 | 0.7 ± 1.1 | 0.2 ± 0.5 | 0.2 ± 0.5 |
Collected over All subjects were exposed to Xenaderm Ointment and Xenaderm vehicle at Day 1. The exposures were occluded under Finn Chambers for 24 hours.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Xenaderm Ointment - Subjects Acted as Own Comparator | — | 0/36 (0%) | 3/36 (8.3%) |
| Event | Xenaderm Ointment - Subjects Acted as Own Comparator |
|---|---|
| Skin IrritationSkin and subcutaneous tissue disorders | 3/36 |
| Age, Categorical(Participants) | Xenaderm vs. Vehicle - Subjects Acted as Own Comparator |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 37 |
| >=65 years | 0 |
| Age, Continuous(years) | Xenaderm vs. Vehicle - Subjects Acted as Own Comparator |
|---|---|
| Mean | 37.5 ± 10.7 |
| Sex: Female, Male(Participants) | Xenaderm vs. Vehicle - Subjects Acted as Own Comparator |
|---|---|
| Female | 20 |
| Male | 18 |
| Region of Enrollment(participants) | Xenaderm vs. Vehicle - Subjects Acted as Own Comparator |
|---|---|
| United States | 38 |
No study locations are listed for this record.
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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