Clinical trial NCT03134352 (phase 2, status: completed)
Conditions: eczema
ICD codes: B00.0, L20.82, L20.84, L20.83, H01.131, H01.132, H01.133
Drugs: zl-3101, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects between 18 and 65 years of age inclusive, at the time of
             signing the informed consent; from outpatient clinic;

          2. Subjects with a diagnosis of subacute eczema (Zhao 2001). Subacute eczema is often
             developed from improperly treated acute eczema or a few with presented subacute eczema
             from early on-set. Subacute eczema usually presents with papule, excoriations,
             crusting and pruritus. Occasionally patient will present with papulovesicle, blister
             and erosion. Patients also need to meet the requirement of:

               -  Subjects must have body surface area (BSA) disease involvement between 3-10%
                  (inclusive) as assessed by palm method;

               -  IGA score of 2 or 3;

               -  Skin lesions should be on the trunk or extremities, without palms/soles,
                  face/scalp, and vulvar areas involved;

          3. Based on TCM theory (Zheng 2002), patients with TCM "damp - heat" symptoms to be
             included. It is subject to TCM investigator's assessment, and symptoms could be (but
             not limited to):

               -  Main symptoms: erythema, pruritus, papule with less exudation;

               -  Secondary symptoms: Mild infiltration, excoriations, crusting, papulovesicle,
                  blister, irritability, thirst, yellowish urine and dry stool;

               -  Tongue and pulse analysis: red tongue with yellow or yellowish coating, slippery
                  pulse model;

          4. Subjects are general in good health; except for eczema, there are no other health
             conditions that possibly interfere with the study results;

          5. A signed and dated written informed consent is obtained from the subject.

        Exclusion Criteria:

          1. The subject presents with or has the history of any systemic disorders or active skin
             diseases (e.g. psoriasis) that would in any way confound interpretation of the study
             results;

          2. The subject has a current complication of overt bacterial, fungal or viral infection
             for which treatment with anti-infective are indicated;

          3. Have the history of hepatic and kidney function insufficiency, hepatic dysfunction ALT
             or AST>1.5 ULN, kidney function BUN, Cr>1.5 ULN;

          4. QT interval corrected according to Bazett's formula or QT interval corrected according
             to Fridericia's formula ≥450 msec; or QTc ≥480 msec in subjects with bundle branch
             block;

          5. Have the history or examination verified by physical and screening of clinically
             significant cardiovascular, pulmonary, gastrointestinal, liver, renal, hematological,
             neurological, abnormalities and psychology disorders which will interfere with the
             efficacy and/or safety of the individual subject;

          6. History of allergy to any component of test medications to be used in the study;

          7. The subject has been exposed to below therapy within the set timeframe:

               -  Systemic administration of anti-histamine agents 1 week

               -  Systemic administration of corticosteroid 4 weeks;

               -  Topical corticosteroid agents administered in the diseased skin 1 week;

               -  Systemic administration of immunosuppressive drugs 4 weeks;

               -  Topical immunosuppressive drugs administered in the diseased skin 1 week;

               -  Systemic administration of any TCM drugs 2 weeks;

               -  Topical administration of any TCM drugs 1 week;

               -  UV therapy 4 weeks

             The use of inhaled/intranasal steroids is permitted prior to and during the conduct of
             the study if already being used by the subject.

          8. The subject has a past history of alcohol or drug abuse;

          9. Pregnant women (as confirmed by a positive urine human chorionic gonadotrophin (HCG)
             test), women who are breast feeding, or sexually active women of child bearing
             potential who are not practicing an acceptable method of birth control (birth control
             pill, patch, implant, barrier with spermicidal jelly, IUD, etc.), as determined by the
             investigator. An acceptable method of birth control must be used during the entire
             study in sexually active women of childbearing potential. A woman of childbearing
             potential is defined as one who is biologically capable of becoming pregnant.
             Abstinence is considered as a medically acceptable form of contraception;

         10. The subject has received an investigational drug or participated in any other research
             trial within 30 days;

         11. Other subjects that investigator deemed as unsuitable for the trial;

         12. Subject's EASI score reaches 2 and above for lichenification and/or edema.