Trial Outcomes & Findings for Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment (NCT NCT00644917)

NCT ID: NCT00644917

Last Updated: 2014-01-13

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 38 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2014-01-13

Participant Flow

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.

Participant milestones

Measure	Xenaderm Ointment - Subjects Acted as Own Comparator Two 20 mg samples of Xenaderm Ointment and two 20 mg samples of Vehicle were applied in Finn Chambers to four test sites of the left side of each subject's back; a fifth test site was covered with an empty Finn Chamber as a control site
Overall Study STARTED	38
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Xenaderm Ointment - Subjects Acted as Own Comparator Two 20 mg samples of Xenaderm Ointment and two 20 mg samples of Vehicle were applied in Finn Chambers to four test sites of the left side of each subject's back; a fifth test site was covered with an empty Finn Chamber as a control site
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment

Baseline characteristics by cohort

Measure	Xenaderm vs. Vehicle - Subjects Acted as Own Comparator n=38 Participants Subjects received duplicate 20 mg applications of Xenaderm Ointment and Xenaderm vehicle contained in Finn Chambers, to the left sides of their backs
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37.5 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: Intent-to-Treat (ITT)

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.

Outcome measures

Measure	Xenaderm Ointment - Irradiated n=36 Participants 20 mg samples of Xenaderm Ointment applied in a Finn Chambers to test site the left side of each subject's back - then irradiated	Xenaderm Vehicle - Irradiated n=36 Participants 20 mg sample of Vehicle applied in Finn Chamber to test site on the left side of each subject's back - then irradiated	Control - Irradiated n=36 Participants test site was covered with an empty Finn Chamber as a control site - then irradiated	Xenaderm Ointment - Non-irradiated n=36 Participants 20 mg samples of Xenaderm Ointment applied in a Finn Chambers to test site the left side of each subject's back - not irradiated	Xenaderm Vehicle - Non-irradiated n=36 Participants 20 mg samples of Xenaderm Vehicle applied in a Finn Chambers to test site the left side of each subject's back - not irradiated
Skin Reaction Score Day 2 at patch removal	0.4 units on a scale Standard Deviation 0.5	0.5 units on a scale Standard Deviation 0.6	0.1 units on a scale Standard Deviation 0.2	0.4 units on a scale Standard Deviation 0.5	0.5 units on a scale Standard Deviation 0.6
Skin Reaction Score Day 2 immediately post UV radiation	0.3 units on a scale Standard Deviation 0.6	0.7 units on a scale Standard Deviation 0.9	0.5 units on a scale Standard Deviation 0.8	0.2 units on a scale Standard Deviation 0.5	0.4 units on a scale Standard Deviation 0.6
Skin Reaction Score Day 3 - 24 hours post UV radiation	0.5 units on a scale Standard Deviation 1.0	0.8 units on a scale Standard Deviation 1.1	0.9 units on a scale Standard Deviation 1.1	0.3 units on a scale Standard Deviation 0.6	0.2 units on a scale Standard Deviation 0.4
Skin Reaction Score Day 4 - 48 hours post UV radiation	0.4 units on a scale Standard Deviation 0.8	0.6 units on a scale Standard Deviation 1.0	0.7 units on a scale Standard Deviation 1.1	0.2 units on a scale Standard Deviation 0.5	0.2 units on a scale Standard Deviation 0.5

Adverse Events

Xenaderm Ointment - Subjects Acted as Own Comparator

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Xenaderm Ointment - Subjects Acted as Own Comparator n=36 participants at risk Two 20 mg samples of Xenaderm Ointment and two 20 mg samples of Vehicle were applied in Finn Chambers to four test sites of the left side of each subject's back; a fifth test site was covered with an empty Finn Chamber as a control site
Skin and subcutaneous tissue disorders Skin Irritation	8.3% 3/36 • Number of events 3 • All subjects were exposed to Xenaderm Ointment and Xenaderm vehicle at Day 1. The exposures were occluded under Finn Chambers for 24 hours. Tabulations of adverse events were used to qualitatively summarize the events by description, severity, and causality. The tabulations were reviewed for evidence of safety trends unrelated to the phototoxicity assessments.

Additional Information

Jaime E Dickerson, Jr, PhD

Smith & Nephew Biotherapeutics

Phone: 817-302-3914

Email: jaime.dickerson@smith-nephew.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60