Trial Outcomes & Findings for Hydrogel Patch for the Treatment of Eczema (NCT NCT00924508)

Results Overview

Percent change in mean EASI score week 0 to week 6: Each lesion was scored using a 12-point modified Eczema Area and Severity Index (EASI) at baseline and 2 weeks after the 4-week treatment period (week6). An experienced evaluator assessed each lesion on the severity of 4 domains, with higher scores indicating more severity: 1) intensity of redness (erythema), 2) thickness (induration, papulation, oedema), 3) scratching (excoriation) and 4) lichenification (lined skin) as as none (0), mild (1), moderate (2) and severe (3). Pictorial and descriptive instructions guided the evaluator in scoring the lesions based on visual appearance.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

Baseline, 6 weeks

Results posted on

2014-01-31

Participant Flow

Eligible eczema patients from one U.S. clinical site were invited to participate

Consent was initially obtained from 23 participants, but 3 participants withdrew consent

Participant milestones

Participant milestones
Measure	TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
Overall Study STARTED	23
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Hydrogel Patch for the Treatment of Eczema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone n=23 Participants This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
Age, Continuous	45.6 years STANDARD_DEVIATION 19.2 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 weeks

Population: 3 of 23 enrolled participants withdrew consent and did not provide data for analysis. Each participant had 3 lesions treated in the study, one by each of 3 study treatments.

Percent change in mean EASI score week 0 to week 6: Each lesion was scored using a 12-point modified Eczema Area and Severity Index (EASI) at baseline and 2 weeks after the 4-week treatment period (week6). An experienced evaluator assessed each lesion on the severity of 4 domains, with higher scores indicating more severity: 1) intensity of redness (erythema), 2) thickness (induration, papulation, oedema), 3) scratching (excoriation) and 4) lichenification (lined skin) as as none (0), mild (1), moderate (2) and severe (3). Pictorial and descriptive instructions guided the evaluator in scoring the lesions based on visual appearance.

Outcome measures

Outcome measures
Measure	Hydrogel Patch n=20 Lesions Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily. After 4 weeks of occlusion therapy, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.	TAC 0.1% n=20 Lesions Patients were instructed to apply TAC 0.1% twice daily to one lesion. After 4 weeks, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.	Patch + TAC n=20 Lesions Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily and triamcinolone (TAC) 0.1% cream twice daily to one lesion. After 4 weeks of occlusion + TAC treatment, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
Change in Disease Severity: Percent Change in Mean EASI Score	-47 percentage change Interval -100.0 to 17.0	-56 percentage change Interval -100.0 to 0.0	-61 percentage change Interval -100.0 to 17.0

SECONDARY outcome

Timeframe: 6 weeks

Population: 3 of 23 enrolled participants withdrew consent and did not provide data for analysis. Each participant had 3 lesions treated in the study, one by each of 3 study treatments.

Outcome measures

Outcome measures
Measure	Hydrogel Patch n=20 Participants Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily. After 4 weeks of occlusion therapy, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.	TAC 0.1% Patients were instructed to apply TAC 0.1% twice daily to one lesion. After 4 weeks, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.	Patch + TAC Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily and triamcinolone (TAC) 0.1% cream twice daily to one lesion. After 4 weeks of occlusion + TAC treatment, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
Number of Adverse Events Associated With Treatment	0 Adverse events	—	—

Adverse Events

TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone

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

John Koo, MD

UCSF

Phone: 415-476-6281

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place