Inflammatory lichen/keratotic dermatoses (e.g. chronic eczema, neurodermatitis, amyloidosis)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Be able to understand and follow the trial procedures, voluntarily participate in the trial and sign the informed consent form; 2. Age 18-65 years inclusive, male or female; 3. Patients diagnosed with chronic eczema, neurodermatitis, primary skin amyloidosis, total skin lesion area accounting for 2-8% of body surface area, and medical history >=3 months before screening, mild and moderate patients with stable disease judged by the investigator; 4. Target lesion (IGA) >=3 at screening and baseline visits; 5. The study doctor assessed that local lesions were suitable for treatment with tazarotene betasone; 6. Willing and able to follow scheduled visits, treatment plans, picture collection and other study procedures;
Exclusion criteria
Exclusion criteria: 1. Allergic to the investigational drug and related ingredients; 2. Pregnant, expectant or lactating women; 3. Lesions are only located in special parts such as head, face, vulva and other sensitive parts with rich hair or thin skin. 4. Bacterial, fungal and viral infections with skin lesions in acute phase or combined activities. 5. Patients with serious concomitant diseases at screening, requiring systemic hormone therapy or other intervention measures, affecting the evaluation of efficacy; 6. Those who have had or currently have serious respiratory system, cardiovascular and cerebrovascular diseases, liver, kidney, digestive tract, musculoskeletal diseases, genitourinary system, immunity, endocrine diseases (such as uncontrolled diabetes), metabolism, mental nerves and other diseases, which may affect the safety or result evaluation of the subjects according to the judgment of the investigator. 7. Use of biological agents within 3 months before enrollment; systemic use of JAK inhibitors, glucocorticoids, retinoids and immunosuppressants within the first 4 weeks; phototherapy within the first 4 weeks; use of systemic traditional Chinese medicines and Chinese patent medicines within the first 2 weeks; use of local treatment drugs such as topical corticosteroids (TCS), topical calcineurin inhibitors (TCI) and topical retinoids for target lesions within the first 1 week; 8. Any subject who, in the opinion of the investigator, is not suitable for participation in this clinical study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion IGA(Investigators Global Assessment)0/1 achieve; | — |
Secondary
| Measure | Time frame |
|---|---|
| recurrence rate;Improvement from baseline in target lesions (hyperkeratosis, hypertrophy, lichenization);dermatology life quality index, DLQI;2-point decrease of Target lesion IGA;VAS;incidence of adverse reactions; | — |
Countries
China
Contacts
Xi'an Jiaotong University Second Affiliated Hospital