A double-blind randomized controlled assessment of Cottonique« underwear products vs control among patients with underwear contact dermatitis

Poster Presentation, American Contact Dermatitis Society Annual Meeting, March 2009. 

Gregorio-Elizaga Abigail, Verallo-Rowell VM. 

 

POSTER Number one form of scientific study, called double-blind randomized controlled trial, shows prototype underwear products from Cottonique, truly effective for people allergic to regular underwear. 

 

ABSTRACT :

The purpose of the study was to first confirm that subjects who appeared to be, or thought they were truly allergic to underwear. This was done by a 5 day skin testing procedure where 98 allergy-causing chemicals (allergens), on day one, were applied to the skin, and kept firmly in place; removed on day 3, at which time, and after another 2 days the skin was examined for any reaction to the allergens.  At least one positive reaction to a chemical known to be present in underwear (used in the production of the textile, or of the article of clothing, or its accessories, or the laundry soap or softener) confirmed the underwear allergy. 

 

On these subjects Cottonique, Inc. underwear were compared with a Control with similar claims to being “hypoallergenic” or “100% cotton”. At baseline, then Weekly for 4 weeks, the effect of using the underwear products were evaluated in a “double-blind” way. This means neither the subjects  nor the investigating physician did not know which type of underwear   was being used. The physician used not just qualitative measures (how subjects felt, or thought about the underwear), but also used dermatological instruments that measured the effects on the skin. 

At the end of the study, the instruments uniformly showed a decline in redness and skin darkening which are signs of inflammation; while 

 

Abigail Gregorio, MD; VMVerallo-Rowell, MD; VSRC Research Team

 

MAIN OUTCOME MEASURES Quantitative and qualitative measurements were used to evaluate the effect of using Cottonique, Inc. vs Control in UCD. Quantitative measurements of selected sites of the skin showing UCD include the use of the Mexameter, Tewameter, and Corneometer while two qualitative measures of overall assessment (clinical appearance and pattern of UCD skin lesions, adverse reactions, photographs) were made: the patient’s and that of the physician investigators. 

 

RESULTS Quantitative measurement on subjects under the Cottonique group using the Mexameter showed a decline in the melanin and erythema index from baseline to follow-up. Subjects under the same group also showed a consistent increase in the Corneometer reading. Tewameter readings, on the other hand, showed a decrease on the top area of skin site while having slight increase on the bottom area. Subjects’ assessments are very similar and also mirror the changes seen in the quantitative data while the doctors’ evaluations are also consistent with these results noting that skin improvement is 20% more likely on those using the Cottonique underwear.