An interventional study of Standard-of-care treatment for AD and Accu-patch pellet in Atopic Dermatitis, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-05.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
The purpose of this study is to see if acupressure will be effective at reducing itch in people with atopic dermatitis (AD).
Atopic dermatitis (AD) is recognized as a major and common problem worldwide. In the United States, AD and related eczematous symptoms affect 17% of the population; 1 in 10 individuals report having experienced symptoms causing quality of life (QOL) distress, including itching/scratching, red/inflamed rash, excessive dryness/scaling, and/or symptoms lasting ≥ 14 days. Two-thirds of these subjects noted at least moderate to severe symptoms, with itch being the most disturbing. Effective treatment of AD and of pruritus (itching) are interconnected. Treating AD will decrease the stimulus for the itch, whereas treating pruritus will decrease the feedback cycle brought on when a patient scratches the skin continually. Effective medications for AD and related symptoms include topical corticosteroids and calcineurin inhibitors. Oftentimes, these remedies are insufficient at treating the itch component of the disease. There is demand for alternative, complementary treatments for AD-related pruritus.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 15 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
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Exclusion Criteria:
This group of subjects will serve as the control group and will follow a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
Other: Standard-of-care treatment for AD
This group of subjects will follow a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they will use 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.
Device: Accu-patch pellet
Subjects will receive standard of care treatment for atopic dermatitis, including moisturizers and topical corticosteroids, per their dermatologist.
The accu-patch pellets will be applied to the LI11 pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times a week for 1 month.
Change in Itch Intensity as Measured by a Change in Visual Analog Scale (VAS) Score
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.
Time frame: Baseline and 4 weeks
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score
The 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.
Time frame: Baseline and 4 weeks
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Area Subscale Score
The 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.
Time frame: Baseline and 4 weeks
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Erythema Subscale Score
The 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.
Time frame: Baseline and 4 weeks
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Infiltration/Papulation Subscale Score
The 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.
Time frame: Baseline and 4 weeks
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Excoriation Subscale Score
The 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.
Time frame: Baseline and 4 weeks
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Lichenification Subscale Score
The 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.
Time frame: Baseline and 4 weeks
| Milestone | Control Group | Accu-patch Pellet |
|---|---|---|
| Started | 7 | 8 |
| Completed | 4 | 7 |
| Not completed | 3 | 1 |
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.
| centimeters | Control Group | Accu-patch Pellet |
|---|---|---|
| Change in Itch Intensity as Measured by a Change in Visual Analog Scale (VAS) Score | 0.8 (-3.2 to 1.8) | -5.0 (-11.0 to 0.5) |
The 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.
| units on a scale | Control Group | Accu-patch Pellet |
|---|---|---|
| Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score | 0.5 (0 to 3) | -1 (-3 to 0) |
The 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.
| units on a scale | Control Group | Accu-patch Pellet |
|---|---|---|
| Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Area Subscale Score | 0 (0 to 1) | -1 (-3 to 1) |
The 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.
| units on a scale | Control Group | Accu-patch Pellet |
|---|---|---|
| Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Erythema Subscale Score | 0 (-1 to 1) | -1 (-3 to 1) |
The 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.
| units on a scale | Control Group | Accu-patch Pellet |
|---|---|---|
| Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Infiltration/Papulation Subscale Score | 0 (-2 to 1) | -1 (-2 to 0) |
The 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.
| units on a scale | Control Group | Accu-patch Pellet |
|---|---|---|
| Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Excoriation Subscale Score | 0 (-2 to 2) | -1 (-2 to 0) |
The 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.
| units on a scale | Control Group | Accu-patch Pellet |
|---|---|---|
| Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Lichenification Subscale Score | 0 (-1 to 1) | -1 (-2 to 0) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | — | 0/7 (0%) | 0/7 (0%) |
| Accu-patch Pellet | — | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | Control Group | Accu-patch Pellet | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 8 | 14 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | Control Group | Accu-patch Pellet | Total |
|---|---|---|---|
| Mean | 39.7 ± 18.3 | 35.1 ± 11.3 | 37.3 ± 15.2 |
| Sex: Female, Male(Participants) | Control Group | Accu-patch Pellet | Total |
|---|---|---|---|
| Female | 1 | 4 | 5 |
| Male | 6 | 4 | 10 |
| Region of Enrollment(participants) | Control Group | Accu-patch Pellet | Total |
|---|---|---|---|
| United States | 7 | 8 | 15 |
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