EUCTR2010-023543-15-FI进行中（未招募）不适用
Double-blind, placebo-controlled, multi-centre Phase II study to investigate dose response, safety, tolerability and efficacy of topical twice daily doses of 2.5% and 5% cis-urocanic acid in comparison to active comparator 0.1% Protopic® for up to 28 days in patients with moderate or severe atopic dermatitis
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Informed consent obtained prior to any screening procedure
- •2. Caucasian male or female patient
- •3. At least 18 years of age
- •4. Weight at least 45 kg
- •5. Patient with moderate or severe chronic atopic dermatitis
- •6. Good general health ascertained by medical history, physical examination and laboratory determinations, showing no signs of clinically significant findings, except chronic atopic dermatitis
- •7. Negative pregnancy test (premenopausal female patient) at screening and use of adequate contraceptive measures (both male and female patients) throughout the study and 30 days after the last cis-UCA dose
- •- Premenopausal female patient should be either surgically sterile or using a reliable contraception method: intrauterine device (hormonal or non-hormonal); oral combination pill or hormonal contraception patch; or two of the following: intra-vaginal hormonal ring, oral contraceptive containing progestin only, spermicidal foam, condom, sterilization of male sexual partner (surgical vasectomy)
- •- Patient with no current heterosexual relationship may be included according to the judgment of the Investigator
- •- If menopause occurred 2 years ago at the minimum, no contraception is required for a female participant, nor pregnancy test
- •- Reliable contraception for a male patient is concordant with above listed methods for females, as applicable
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of other significant skin disease (e.g., any skin disease requiring hospitalization), or skin manifestations of allergic illness or other dermatologic condition, except chronic moderate or severe atopic dermatitis, that would interfere with the trial assessments or compromise the patient’s safety according to the opinion of the Investigator
- •2. Present symptoms of other skin diseases, except chronic atopic dermatitis, that could disturb the study assessment and evaluation of the skin, according to the opinion of the Investigator
- •3. Current use of any active systemic medication (i.e., oral, subcutaneous, intravenous) for chronic atopic dermatitis within one month (30 days)
- •4. Current use of active topical medication in the planned investigational area for chronic atopic dermatitis within two weeks (14 days)
- •5. History of a sunny holiday, UV-light therapy or solarium use within one month (30 days) before beginning of study treatments, or planning such during the study or within seven (7) days after the study
- •6. Allergy to cis-UCA, or any constituents of the placebo emulsion cream (decyl oleate, cetearyl alcohol, glycerine, sodium cetearyl sulfate and methylparaben) or any constituents of Protopic® ointment (white soft paraffin, liquid paraffinpropylene carbonate, white beeswax, hard paraffin)
- •7.History of any skin-related cancer
- •8. Congenital or acquired immunodeficiency or ongoing therapy that cause immunosuppression
- •9. Earlier participation in a clinical study performed with cis-UCA
- •10. Any clinically significant laboratory test result
- •11. Suspected current drug or alcohol abuse
- •12. Clinically significant illness during the 4 weeks prior to the first dose administration (as determined by the Investigator)
- •13. Any other condition that in the opinion of the Investigator would interfere with the evaluation of the study results or constitute a health hazard for the patient
- •14. Unwillingness or doubtful capacity to comply with the protocol
- •15. Doubtful availability, in the opinion of the Investigator, to complete the study
研究者
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