Trial Outcomes & Findings for Contact Sensitization Potential of 828 Ointment (NCT NCT00767676)

Results Overview

To qualify for the claim of a reduced sensitization potential, all subjects completing the study could exhibit a value of no more than 1.5 on the Jordan-King Scale \[scale is 0 (no visible reaction) to 5 (severe erythema)\] No statistical analyses were performed.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

259 participants

Primary outcome timeframe

7 weeks

Results posted on

2014-06-27

Participant Flow

Healthy adult volunteers, 18 years of age and older

Participant milestones

Participant milestones
Measure	HP828-101 HP828-101 : Nine topical patch applications, each the approximate size of a nickel, over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
Overall Study STARTED	259
Overall Study COMPLETED	205
Overall Study NOT COMPLETED	54

Reasons for withdrawal

Reasons for withdrawal
Measure	HP828-101 HP828-101 : Nine topical patch applications, each the approximate size of a nickel, over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
Overall Study Investigator error	54

Baseline Characteristics

Contact Sensitization Potential of 828 Ointment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HP828-101 n=259 Participants HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	256 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	40.9 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	177 Participants n=5 Participants
Sex: Female, Male Male	82 Participants n=5 Participants
Region of Enrollment United States	259 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 weeks

Population: Per protocol

To qualify for the claim of a reduced sensitization potential, all subjects completing the study could exhibit a value of no more than 1.5 on the Jordan-King Scale \[scale is 0 (no visible reaction) to 5 (severe erythema)\] No statistical analyses were performed.

Outcome measures

Outcome measures
Measure	HP828-101 n=205 Participants HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
Number of Participants That Exhibited a Score Less Than 1.5 on the Jordan-King Scale	205 participants

Adverse Events

HP828-101

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jaime Dickerson, PhD

Smith & Nephew Biotherapeutics

Phone: 817-302-3914

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60