Trial Outcomes & Findings for Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment (NCT NCT00645164)

Last Updated: 2010-06-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

59 participants

Primary outcome timeframe

48-hours post irradiation

Results posted on

2010-06-08

Participant Flow

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subjects were enrolled in the study, of which 58 were randomized and received test article. 7 subjects were prematurely withdrawn - 1 prior to receiving test articles; 52 subjects completed the study and were evaluable.

Participant milestones

Participant milestones
Measure	Xenaderm Subject serves as own control
Overall Study STARTED	59
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Xenaderm Subject serves as own control
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	4
Overall Study Protocol Violation	1

Baseline Characteristics

Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Xenaderm n=59 Participants Subject serves as own control
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	38.8 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment United States	59 participants n=5 Participants

PRIMARY outcome

Timeframe: 48-hours post irradiation

Population: Analysis was based on number of subjects who completed the study.

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.

Outcome measures

Outcome measures
Measure	Xenaderm n=52 Participants Subject serves as own control
Frequency Distribution of Skin Irritation Scores Minimal (doubtful) response (1)	10 Scores on a scale
Frequency Distribution of Skin Irritation Scores Definite, mild erythema (2)	3 Scores on a scale
Frequency Distribution of Skin Irritation Scores Moderate erythema (3)	0 Scores on a scale
Frequency Distribution of Skin Irritation Scores No reaction (0)	39 Scores on a scale
Frequency Distribution of Skin Irritation Scores Erythema with slight edema (4)	0 Scores on a scale
Frequency Distribution of Skin Irritation Scores Erythema with marked edema (5)	0 Scores on a scale
Frequency Distribution of Skin Irritation Scores Erythema w/infiltration w/wo vesiculation (6)	0 Scores on a scale
Frequency Distribution of Skin Irritation Scores Large vesiculo-bullous reaction (7)	0 Scores on a scale

Adverse Events

Xenaderm

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Xenaderm n=59 participants at risk Subject serves as own control
General disorders Burning at test site	5.1% 3/59 • Number of events 3
General disorders Itching at test site	13.6% 8/59 • Number of events 8
General disorders Fever	5.1% 3/59 • Number of events 3
Nervous system disorders Headache	10.2% 6/59 • Number of events 6
Skin and subcutaneous tissue disorders Tape reaction	28.8% 17/59 • Number of events 17

Additional Information

Herbert B. Slade MD, FAAAAI

DFB Pharmaceuticals

Phone: 817.302.3919

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place