Trial | NCT00644917

Official Title

Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment

Phase
Phase 1

Lead Sponsor
Healthpoint

Study Type
Interventional

Status
Completed Results Posted

Indication/Condition
Healthy

Intervention/Treatment
castor oil trypsin myroxylon balsamum ...
Xenaderm Placebo

Study Participants
38

The product is being tested to see if exposure to light causes toxic reactions on the skin.

Study Started

Feb 29

2008

Primary Completion

Feb 29

2008

Study Completion

Feb 29

2008

Results Posted

Jan 13

2014

Estimate

Last Update

Jan 13

2014

Estimate

Drug Xenaderm

20mg under Finn chambers

Drug Placebo

20mg under Finn chambers

B Placebo Comparator

Placebo comparator

Drug Placebo

C No Intervention

Subjects serve as own controls.

A Experimental

Drug

Drug Xenaderm

Criteria

Inclusion Criteria:

Healthy subjects

Exclusion Criteria:

Under 18 years of age

Summary

Xenaderm Ointment - Subjects Acted as Own Comparator

All Events

Event Type	Organ System	Event Term	Xenaderm Ointment - Subjects Acted as Own Comparator

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.

Xenaderm Ointment - Irradiated

Day 2 at patch removal

0.4

units on a scale (Mean)

Standard Deviation: 0.5

Day 2 immediately post UV radiation

0.3

units on a scale (Mean)

Standard Deviation: 0.6

Day 3 - 24 hours post UV radiation

0.5

units on a scale (Mean)

Standard Deviation: 1.0

Day 4 - 48 hours post UV radiation

0.4

units on a scale (Mean)

Standard Deviation: 0.8

Xenaderm Vehicle - Irradiated

Day 2 at patch removal

0.5

units on a scale (Mean)

Standard Deviation: 0.6

Day 2 immediately post UV radiation

0.7

units on a scale (Mean)

Standard Deviation: 0.9

Day 3 - 24 hours post UV radiation

0.8

units on a scale (Mean)

Standard Deviation: 1.1

Day 4 - 48 hours post UV radiation

0.6

units on a scale (Mean)

Standard Deviation: 1.0

Control - Irradiated

Day 2 at patch removal

0.1

units on a scale (Mean)

Standard Deviation: 0.2

Day 2 immediately post UV radiation

0.5

units on a scale (Mean)

Standard Deviation: 0.8

Day 3 - 24 hours post UV radiation

0.9

units on a scale (Mean)

Standard Deviation: 1.1

Day 4 - 48 hours post UV radiation

0.7

units on a scale (Mean)

Standard Deviation: 1.1

Xenaderm Ointment - Non-irradiated

Day 2 at patch removal

0.4

units on a scale (Mean)

Standard Deviation: 0.5

Day 2 immediately post UV radiation

0.2

units on a scale (Mean)

Standard Deviation: 0.5

Day 3 - 24 hours post UV radiation

0.3

units on a scale (Mean)

Standard Deviation: 0.6

Day 4 - 48 hours post UV radiation

0.2

units on a scale (Mean)

Standard Deviation: 0.5

Xenaderm Vehicle - Non-irradiated

Day 2 at patch removal

0.5

units on a scale (Mean)

Standard Deviation: 0.6

Day 2 immediately post UV radiation

0.4

units on a scale (Mean)

Standard Deviation: 0.6

Day 3 - 24 hours post UV radiation

0.2

units on a scale (Mean)

Standard Deviation: 0.4

Day 4 - 48 hours post UV radiation

0.2

units on a scale (Mean)

Standard Deviation: 0.5

Age, Continuous

37.5

years (Mean)

Standard Deviation: 10.7