Clinical Study


Clinically Tested. Dermatologist Verified.

A double-blind, randomized controlled trial demonstrated significant improvement in patients with underwear contact dermatitis when using Cottonique products.

IRB Approved Double-Blind Study 51 Participants 4-Week Trial
88%
of Cottonique users showed clinical improvement
10×
more likely to report reduced redness & itching
20×
more likely to receive "improved" rating from physicians
98
allergens tested in comprehensive patch testing panel

About the Study

In 2008, VMV Skin Research Center + Clinics (VSRC) conducted a rigorous clinical trial to evaluate Cottonique underwear for patients diagnosed with underwear contact dermatitis (UCD).

The study compared Cottonique products against a leading "100% cotton" competitor brand in a double-blind, randomized controlled trial—the gold standard of clinical research.

All participants had their diagnosis confirmed through comprehensive patch testing using 98 allergens, including the NACDG 65-allergen series and 33 textile-specific allergens from Chemotechnique Diagnostics.

Study Details

Study Design Double-blind RCT
Participants 51 adults with confirmed UCD
Duration 4 weeks
Institution VMV Skin Research Center + Clinics, Makati, Philippines
Ethics Approval IRB approved by VSRC
Lead Investigators Abigail Gregorio, MD; VMVerallo-Rowell, MD

Methodology

Patient Selection & Diagnosis

Participants were adults with symptoms and clinical features of underwear contact dermatitis. All patients underwent comprehensive patch testing to confirm their diagnosis using:

  • NACDG 65-allergen standard series
  • 33 textile-specific allergens (dyes, resins, rubber chemicals)
  • Readings at 48, 72, and 96 hours following NACDG protocols

Only patients with relevant positive patch test reactions were enrolled, ensuring all participants had confirmed contact allergy.

Double-Blind Protocol

To eliminate bias, neither participants nor investigators knew which underwear brand each patient received:

  • Products were repackaged in identical packaging by the VSRC Pharmacy
  • Random assignment using numbered paper selection
  • Both Cottonique and control underwear were similar in appearance, color, and design
  • Each participant received 3 pieces of their assigned underwear
Assessment Instruments

Skin condition was assessed at baseline and after 4 weeks using validated instruments:

  • Mexameter – Measures skin redness (Erythema Index) and pigmentation (Melanin Index)
  • Corneometer – Measures skin hydration levels
  • Tewameter – Measures skin barrier function (trans-epidermal water loss)
  • Clinical examination – Weekly visual assessment by dermatologists
  • Patient questionnaires – Self-reported symptoms including itching, rashes, and comfort

Results

Physicians rated Cottonique users as 20× more likely to show improvement compared to the control group

10× more likely to report improvement in redness
10× more likely to report improvement in itching
10× more likely to report improvement in skin darkening
5× more likely to report improvement in rashes

Patient-Reported Outcomes

Outcome Measure Cottonique Control
Improvement in redness 89% improved 39% improved
Improvement in rashes 79% improved 52% improved
Improvement in itching 96% improved 35% improved
Improvement in skin darkening 68% improved 26% improved
Physician-rated overall improvement 92% improved 59% improved
Adverse events 0 reported 0 reported

"Across all parameters—instrumental, patient, and physician assessment—the skin of those wearing Cottonique brand underwear was much more significantly improved. While both were claimed to be '100% cotton' and hypoallergenic, the Cottonique brand was clearly superior and produced clearing of the UCD in majority of the patients."

— Study Conclusion

Manufacturing Process Comparison

The study revealed that "100% cotton" labeling alone does not guarantee suitability for sensitive skin. The chemicals used in textile processing—not the cotton itself—are often responsible for skin reactions.

Process Standard Apparel Cottonique
Scouring Caustic soda / soda ash Plain water (hydro extractor)
Cleansing Chemical detergents with APEO Mild, non-ionic agents free from APEO
Dyeing Reactive dyes with chromium, copper, lead None
pH Level 8-8.5 (alkaline) 5-7 (skin-balanced)
Softening Paraffin wax, chemical agents None
Shrinkage Control Melamine resins + catalysts Hydro-thermal (water + heat only)

Full Study Documentation

This study was conducted in accordance with standard clinical research protocols and received ethics approval from the Institutional Review Board of VMV Skin Research Center + Clinics.

Funding & Disclosures

External support: Cottonique, Inc.
Internal support: VMV Skin Research Center + Clinics, Skin & Cancer Foundation, Inc.
Conflicts of interest: None declared by investigators

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Clinically Tested

This study was conducted in 2008 at VMV Skin Research Center + Clinics, Makati, Philippines, with external support from Cottonique, Inc. Results may vary based on individual sensitivities and allergen profiles. This study evaluated underwear products; other Cottonique product categories were not included in this specific trial.