Lupus Erythematosus
Conditions
Interventions
Experimental group:Oral hydroxychloroquine + oral DHA
Control group:Oral hydroxychloroquine + oral placebo
Sponsors
North Hospital of Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
12 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 12-60 years old; 2. Meet the diagnostic criteria for limited DLE, the number of skin lesions <3, and the skin lesions are mainly located in the exposed parts of the zygomatic, cheek, nose, and outer ear. All skin lesions must be examined by dermoscopy (DermLite DL3, California, 10 times magnification), and then pathological (HE staining). The results of dermoscopy and pathology must be confirmed by more than 2 dermatologists; The main points of dermoscopy diagnosis include: white scales, follicle horn plugs, red spots, white halos around hair follicles, pigmentation, telangiectasia, and white unstructured areas. The main points of histopathological diagnosis include: hair follicle horn plug, hyperkeratosis, basal cell liquefaction and degeneration, basement membrane thickening, pigment incontinence, upper dermal edema, vasodilation and mild red blood cell extravasation, diffuse dermal fibrosis, mucin deposition, hair follicles And lymphocyte infiltration around sweat glands. 3. The course of the disease is less than 1 year, and he has not taken any one or more of chloroquine, hydroxychloroquine, glucocorticoids, immunosuppressants or dihydroartemisinin in the past month; 4. During the trial period, the informed consent form must be signed in compliance with the medication requirements, and the process of obtaining the informed consent form meets the requirements of the quality management standards for drug clinical trials.
Exclusion criteria
Exclusion criteria: (1) Those suffering from systemic diseases including malignant tumors, active tuberculosis, HIV infection and other diseases; (2) Suffer from chronic diseases, such as: diabetes, hypertension, severe liver and kidney dysfunction (heart function 3-4, ALT and/or AST more than 1.5 times the upper limit of normal, Cr exceeds the upper limit of normal), unstable condition or Uncontrolled ones, those with fundus disease; (3) Women of childbearing age (18-45 years old) who have a positive pregnancy test, or are willing to become pregnant; or breastfeeding patients; (4) Patients who are allergic to hydroxychloroquine, artemisinin or dihydroartemisinin; (5) Those who have participated in other drug clinical trials within three months; (6) Other situations that the investigator thinks are not suitable for inclusion in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dermoscopy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood;Urine; | — |
Countries
China
Contacts
Public ContactHao Wu
North Hospital of Huashan Hospital, Fudan University
Outcome results
None listed