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

EUCTR2005‐005793‐75‐DE.

Methods Double‐blind randomised parallel‐group design
Participants 40 patients with chronic hand dermatitis rated mild to moderate according to Investigator’s global assessment (score, see page 20) that has persisted for longer than 6 month in spite of attempts to identify and remove the cause
Inclusion criteria
  • Men and women 18 to 70 years of age

  • Chronic hand dermatitis rated mild to moderate according to investigator’s global assessment (score, see page 20) that has persisted for longer than 6 months in spite of attempts to identify and remove the cause

  • Physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study

  • Danish sites: sexually active females of child‐bearing potential should be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, vaginal or transdermal, injection) or intrauterine device (IUD) during the trial and at least 15 days after the end of the study

  • German sites: sexually active females of child‐bearing potential should be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide

  • Danish sites: an epicutaneous test was performed within the previous 36 months before the first treatment and was documented in the participant record

  • German sites: an epicutaneous test was performed within the previous 12 months before the first treatment and was documented in the participant record

  • Written informed consent obtained


Exclusion criteria
  • Primary hyperkeratotic forms of dermatitis, hand dermatosis other than eczematous dermatoses, or acute infection

  • Allergic contact dermatitis if the allergen is identified and patient remained in contact with the allergen

  • Metal‐workers who are in permanent contact with cutting fluids

  • Sun‐tanned or hyperpigmentation or tattoos in the test fields

  • Dark‐skinned persons whose skin colour prevents ready assessment of skin reactions

  • Treatment within 3 months before study day 1 with systemic medications (i.e. glucocorticoids or immune modulators), treatment within 2 weeks with topical glucocorticosteroids, or treatment with other systemic or locally acting medications that might counter or influence the trial aim within 2 weeks before study day 1 and during the study

  • UV therapy within 4 weeks before study day 1 and during the study

  • Medical history of skin cancer in the area of the hands or generalised skin cancer

  • Known to be drug‐resistant for this indication

  • Evidence of drug or alcohol abuse

  • Pregnancy or nursing

  • Symptoms of a clinically significant illness that may influence the outcome of the study in the 4 weeks before study day 1 and during the study

  • Participation in another clinical trial involving pharmaceutical products in the 4 weeks before study day 1

  • Known allergic reactions to components of the study preparations

  • German sites: known allergic reactions with symptoms such as asthma, allergic rhinitis, or urticaria to 2‐acetoxy‐benzoic acid (acetylsalicylic acid) or other non‐steroidal antirheumatics (because of possible cross‐allergic reactions)

  • If in the opinion of the investigator or physician performing the initial examination, the patient should not participate in the study (e.g. due to probable non‐compliance or inability to understand the study and give adequately informed consent)

Interventions Intervention
• ASF‐1075 cream
Control intervention
• Placebo cream
Outcomes Primary outcomes of the trial
  • Clinical assessment of skin condition using the hand eczema severity index (HECSI)

Notes Current status: not recruiting