Trial Outcomes & Findings for Evaluation of Effects of HP828-101 for Moisture Associated Skin Damage (NCT NCT01108523)

NCT ID: NCT01108523

Last Updated: 2013-12-06

Results Overview

• Recruitment status: TERMINATED
• Study phase: EARLY_PHASE1
• Target enrollment: 7 participants
• Primary outcome timeframe: 15 Days
• Results posted on: 2013-12-06

Participant Flow

Male or female subjects, age ≥ 18 years old, who were receiving care in a Nursing Home or Long Term Acute Care Facility (LTAC) and who had qualifying moisture damaged skin, with denudation in the range of 2 to 64 cm x cm

Participant milestones

Measure	HP828-101 HP828-101 Experimental Formulation
Overall Study STARTED	7
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	HP828-101 HP828-101 Experimental Formulation
Overall Study Protocol Violation	4

Baseline Characteristics

Evaluation of Effects of HP828-101 for Moisture Associated Skin Damage

Baseline characteristics by cohort

Measure	HP828-101 n=7 Participants HP828-101 Experimental Formulation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age Continuous	74.9 years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 Days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4, 8, 12, and 15 days

Outcome measures

Outcome data not reported

Adverse Events

HP828-101

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	HP828-101 n=7 participants at risk HP828-101 Experimental Formulation
Nervous system disorders Metastatic brain cancer	14.3% 1/7 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Jaime Dickerson, 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