Trial Outcomes & Findings for Acupressure in Pruritus for Atopic Dermatitis (NCT NCT01074164)
NCT ID: NCT01074164
Last Updated: 2015-01-05
Results Overview
The VAS score assesses itch intensity in subject's with AD. The VAS consists of a 21.5 cm horizontal line with its left and right boundaries marked by vertical lines. The left boundary vertical line is labeled "Least Itch," and the right boundary vertical line is labeled "Worst Itch." Subjects are instructed to draw a vertical line across this scale that represents the intensity of itch that they are currently experiencing. Vertical lines drawn by subjects towards the left boundary of the horizontal line are associated with less itch intensity, and vertical lines drawn by subjects towards the right boundary of the horizontal line are associated with worse itch intensity. A ruler is then used to measure distance from the left boundary vertical line to the vertical line drawn by the subject to the nearest millimeter. Possible values range from 0 to 21.5 centimeters, with 0 centimeters associated with less itch intensity and 21.5 cm associated with worse itch intensity.
COMPLETED
NA
15 participants
Baseline and 4 weeks
2015-01-05
Participant Flow
Participant milestones
| Measure |
Control Group
This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
|
Accu-patch Pellet
This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
4
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupressure in Pruritus for Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Control Group
n=7 Participants
This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
|
Accu-patch Pellet
n=8 Participants
This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 18.3 • n=5 Participants
|
35.1 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
37.3 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksThe VAS score assesses itch intensity in subject's with AD. The VAS consists of a 21.5 cm horizontal line with its left and right boundaries marked by vertical lines. The left boundary vertical line is labeled "Least Itch," and the right boundary vertical line is labeled "Worst Itch." Subjects are instructed to draw a vertical line across this scale that represents the intensity of itch that they are currently experiencing. Vertical lines drawn by subjects towards the left boundary of the horizontal line are associated with less itch intensity, and vertical lines drawn by subjects towards the right boundary of the horizontal line are associated with worse itch intensity. A ruler is then used to measure distance from the left boundary vertical line to the vertical line drawn by the subject to the nearest millimeter. Possible values range from 0 to 21.5 centimeters, with 0 centimeters associated with less itch intensity and 21.5 cm associated with worse itch intensity.
Outcome measures
| Measure |
Control Group
n=4 Participants
This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
|
Accu-patch Pellet
n=7 Participants
This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
|
|---|---|---|
|
Change in Itch Intensity as Measured by a Change in Visual Analog Scale (VAS) Score
|
0.8 centimeters
Interval -3.2 to 1.8
|
-5.0 centimeters
Interval -11.0 to 0.5
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksThe IGA score is an assessment of AD severity. It is an assessment of the patient's disease state at the time of examination and does not attempt a comparison with any of the patient's previous disease states. Possible scores range from 0 to 5. A score of 0 is associated with no evidence of AD and a score of 5 is associated with severe AD.
Outcome measures
| Measure |
Control Group
n=4 Participants
This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
|
Accu-patch Pellet
n=7 Participants
This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
|
|---|---|---|
|
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score
|
0.5 units on a scale
Interval 0.0 to 3.0
|
-1 units on a scale
Interval -3.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksThe EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining area subscale score, the percent area of skin involvement is determined and assigned a score of 0 to 6, where 0 correlates with no skin involvement, 1 represents \< 10% skin involvement, 2 represents 10-29% skin involvement, 3 represents 30-49% skin involvement, 4 represents 50-69% skin involvement, 5 represents 70-89% skin involvement, and 6 represents 90-100% skin involvement. Possible scores range from 0 to 6, where 0 correlates with better disease severity and 6 correlates with worse disease severity. Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18.
Outcome measures
| Measure |
Control Group
n=4 Participants
This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
|
Accu-patch Pellet
n=7 Participants
This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
|
|---|---|---|
|
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Area Subscale Score
|
0 units on a scale
Interval 0.0 to 1.0
|
-1 units on a scale
Interval -3.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksThe EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the erythema subscale score, erythema is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity. Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18.
Outcome measures
| Measure |
Control Group
n=4 Participants
This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
|
Accu-patch Pellet
n=7 Participants
This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
|
|---|---|---|
|
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Erythema Subscale Score
|
0 units on a scale
Interval -1.0 to 1.0
|
-1 units on a scale
Interval -3.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksThe EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the infiltration/papulation subscale score, infiltration/papulation is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity. Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18.
Outcome measures
| Measure |
Control Group
n=4 Participants
This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
|
Accu-patch Pellet
n=7 Participants
This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
|
|---|---|---|
|
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Infiltration/Papulation Subscale Score
|
0 units on a scale
Interval -2.0 to 1.0
|
-1 units on a scale
Interval -2.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksThe EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the excoriation subscale score, excoriation is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity. Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18.
Outcome measures
| Measure |
Control Group
n=4 Participants
This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
|
Accu-patch Pellet
n=7 Participants
This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
|
|---|---|---|
|
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Excoriation Subscale Score
|
0 units on a scale
Interval -2.0 to 2.0
|
-1 units on a scale
Interval -2.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksThe EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the lichenification subscale score, lichenification is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity. Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18.
Outcome measures
| Measure |
Control Group
n=4 Participants
This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
|
Accu-patch Pellet
n=7 Participants
This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
|
|---|---|---|
|
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Lichenification Subscale Score
|
0 units on a scale
Interval -1.0 to 1.0
|
-1 units on a scale
Interval -2.0 to 0.0
|
Adverse Events
Control Group
Accu-patch Pellet
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mandy Browning
Northwestern University Department of Dermatology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place