pityriasis rubra pilaris, hidradenitis suppurativa, Netherton syndrome, erythrokeratodermia variabilis and erythrokeratoderma progressive symmetrica
Conditions
Interventions
pityriasis rubra pilaris, Netherton syndrome, erythrokeratodermia variabilis and erythrokeratoderma progressive symmetrica:Ixekizumab at different doses in adults and juveniles with different body wei
hidradenitis suppurativa:Ixekizumab at different doses in adults and juveniles with different body weight
Sponsors
Dermatology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical or pathological diagnosis: pityriasis pilaris, pyogenic sweat gland inflammation, Netherton syndrome, variant erythematous keratosis and progressive symmetric erythematous keratosis; 2.6-65 years old: 3. The patient voluntarily joined the study and has signed the written informed consent form approved by Lilly or its designated personnel and the Investigation and Review Board (IRB)/Ethics Review Board (ERB) managing the research center; 4. Must agree to use reliable birth control methods: 1) In the case of male patients, the patients agreed to use reliable contraceptive methods during the study period and at least 12 weeks after the last drug use, whichever is longer. Contraceptive methods include but are not limited to the use of spermicide and condoms; 2) If a female patient with fertility has a negative pregnancy test and agrees to use reliable contraception methods or contraception during the study period and at least 12 weeks after the last drug use, whichever is longer; Contraceptive methods include but are not limited to: oral contraceptives, contraceptive patches, injectable or implantable contraceptives, intrauterine devices, vaginal rings, diaphragms with contraceptive gel or condoms with contraceptive foam; 3) If a female patient is not fertile, her pregnancy test must be negative and she does not need to use any contraceptive method. Non-fertility is defined as: women who have undergone surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation), or women who are = 60 years old, or women who are = 40 years old and<60 years old and have menopause for = 12 months, and who have no fertility potential (= 40 mIU/mL or = 40 IU/L) confirmed by follicle stimulating hormone (FSH) test, or girls who have no menarche; 5. Clinical judgment requires phototherapy and/or systemic therapy.
Exclusion criteria
Exclusion criteria: 1. History of any malignant tumor in the past 5 years, except for completely resected skin squamous cell carcinoma or basal cell carcinoma; 2. Active, untreated, acute or chronic infection (such as untreated tuberculosis), or low immune function, so that participation in the study will pose an unacceptable risk to subjects; 3. Human immunodeficiency virus, hepatitis B virus or hepatitis C virus are positive; 4. Have used any medicine specifically for interleukin 17 before; 5. Have received systemic therapy or phototherapy within the past 4 weeks or within the first 5 half-lives of the baseline, whichever is longer. For biotherapy, the specific clearance period used is: etanercept2.5 times of the upper normal limit, hemoglobin of male subjects2.0 mg/dL; 13. Inoculate live attenuated vaccine within 2 months after recruitment, or expect to vaccinate live attenuated vaccine during treatment; 14. The researcher believes that there are any other circumstances that make the subject unable to follow and complete the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index;Hidradenitis Suppurativa Lesion Area and Severity Index;Netherton Area Severity Assessment score;Eczema Area and Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatology Life Quality Index/Children’s Dermatology Life Quality Index;Visual Analogue Scale of pruritus; | — |
Countries
China
Contacts
Public ContactLin Zhimiao
Dermatology Hospital of Southern Medical University
Outcome results
None listed