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. 2019 Apr 26;2019(4):CD004055. doi: 10.1002/14651858.CD004055.pub2

NCT00614289.

Methods Double‐blind randomised within‐participant design
Participants 30 patients with hand eczema
Inclusion criteria
  • 18 years of age or older

  • Mild to moderate hand dermatitis, according to Investigator Global Assessment

  • Generally healthy, as determined by brief medical history

  • Negative urine test for pregnancy if female, and use of highly effective method of birth control, such as condoms and spermicide, implants, injectables, combined oral contraceptives, intrauterine device (IUD), sexual abstinence, or a vasectomised partner. For those using a hormonal contraceptive method, the dose and type of contraception should stay constant 1 month before enrolment and throughout the study

  • Capable of understanding and signing the consent form


Exclusion criteria
  • Clinically relevant allergic or irritant contact dermatitis and inability to avoid exposure

  • Severe and very severe hand dermatitis according to the Investigator Global Assessment

  • Severe vesiculation or bullae

  • History of psoriasis, contact urticaria, and/or pustular disease of the hands

  • Therapy for the hands with potent topical corticosteroids within 1 month of enrolment

  • Use of systemic treatment with oral retinoids, corticosteroids, or PUVA within 8 weeks before the beginning of the study

  • History of alcoholism or drug abuse

  • History or current evidence of a chronic or infectious skin disease

  • Pregnant or lactating females, or using method of birth control that does not comply with highly effective methods of birth control listed under inclusion criteria; pregnant or lactating females, or using method of birth control that does not comply with highly effective methods of birth control listed under inclusion criteria

Interventions This study is designed as a prospective, randomised, double‐blind right/left comparison of Epikeia coatings to improve hand dermatitis
Outcomes Primary outcomes of the trial
  • Investigator Global Assessment after 85 days within participant (test versus control hands)

  • Hand Eczema Area and Severity Scores after 85 days (within‐participant comparison)


Secondary outcomes of the trial
  • Ordinal scales measuring subjective efficacy, pain, and itching during 85 days

Notes Sponsor: Biomedical Development Corporation
Study has been completed; however we were unable to obtain data from the study authors, who were unresponsive