Clinical Trial: Eczema & Psoriasis

An Open-Label Pilot Study to Evaluate the Efficacy of a Silk-Like Bedding Fabric (DermaTherapy®) As Used in the Treatment of Mild Atopic Dermatitis

This study, completed February 2006, was carried out by the Wake Forest University School of Medicine, Department of Dermatology, in Winston-Salem, North Carolina. The principal investigator was Alan B. Fleischer, Jr., MD.

STUDY DESIGN:
This study involved patients with mild atopic dermatitis (>5% Body Surface Area and 2 or 3 on the Investigator Global Assessment scale). Thirty-seven subjects (average age 16; female 78%) were enrolled. Patients were assigned to sleep on the experimental fabric, in the form of a bed sheet set that included a pillow case, a flat top sheet, and a fitted bottom sheet. The study consisted of an 8-week Treatment Phase. Subjects were permitted to apply moisturizer as needed during the day and in the evening. Subjects were not permitted to use any topical or systemic medication to treat atopic dermatitis while participating in the study.

The primary outcome was the investigator assessment of severity of atopic dermatitis, erythema, papulation/ induration, excoriation, lichenification, scaling, oozing/crusting and global improvement from baseline to week 8. The severity of atopic dermatitis was measured using the Investigator Global Assessment (IGA) scale and the Eczema Area Severity Index (EASI). The secondary outcome was patient assessment of itching and their quality of life. The itching of the subject was measured by the Visual Analog Scale. Satisfaction with the bedding was measured using a Quality of Life Questionnaire at Baseline and Week 8.

In the graphs that follow, “Baseline” results depict assessments of the patients at the beginning of the study, prior to treatment phase. “Week 8” results depict assessments of patients after using the DermaTherapy® bedding for 8 weeks.

STUDY RESULTS:

Improvements in Atopic Dermatitis
Using Investigator Global Assessment

Data in this case had a p-value of 0.0257 using the Wilcoxon Signed Rank Test, indicating that a 97.4% chance that the improvement seen in the study was not a random result.

Improvements in Eczema
Using Eczema Area Severity Index

EASI involves ratings of the area, redness, excoriation, papulation/induration,
lichenification, etc. on the head, neck, trunk, groin, upper and lower extremities.

Data in this case had a p-value of 0.0142 using the Wilcoxon Signed Rank Test, or a 98.6% chance that the improvements relative to eczema were not a random result.

Improvements in Itching
Using Assessment of Itch Ratings

Data in this case had a p-value of 0.0101 using the Wilcoxon Signed Rank Test, or a 99.0% chance that the improvements seen in the study relative to improvements in itching were not a random result.

Improvements in Quality of Life

ASSESSMENT OF CURRENT COTTON BEDDING AT BASELINE

ASSESSMENT OF DermaTherapy® BEDDING AT 8 WEEKS

CONCLUSIONS:
In this study of patients with mild atopic dermatitis, statistically significant improvements were demonstrated in the severity of atopic dermatitis, eczema, the level of itching, and perceived quality of life after only eight weeks of using DermaTherapy® bedding.

In comparison with their current cotton bedding, study participants using DermaTherapy® bedding reported significant improvements in:

• The amount of itching that they experienced,
• Their tendency to scratch,
• Their overall skin appearance,
• The amount of uninterrupted sleep,
• The amount of moisturizers they used,
• And the level of perceived comfort.