Severe acne and acne conglobata
Conditions
Interventions
Experimental group:Adalimumab + Isotretinoin
Control group:Isotretinoin
Sponsors
Dermatology Hosipital of Southern Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with grade IV and above severe acne and acne conglobata, and fully understand the content, nature, methods and possible adverse reactions of the trial, can complete the trial according to the requirements of the protocol; 2) Willing and able to follow the visits and treatment specified in this study; 3) 6 years to 65 years of age (including the boundary value); 4) Subjects (including partners) are willing to have no fertility plan within 6 months after the administration of the study drug and voluntarily take effective contraceptive measures; 5) Female patients are not pregnant or lactating; 6) Use of any monoclonal antibodies or biological drugs (including vaccines and other biological products) within 3 months before the administration of study drugs; 7) Normal biological agent safety screening (hepatitis B, tuberculosis, etc.);
Exclusion criteria
Exclusion criteria: 1) Patients with immune system, neuropsychiatric system, respiratory system, cardiovascular system, digestive tract system, haemolymph system, liver and kidney insufficiency, endocrine and metabolic system, musculoskeletal system disease or other diseases in the past, and the researcher judged that the previous medical history may have an impact on drug metabolism or safety; 2) They are known to be allergic to adalimumab injection or its excipients, and have a history of allergic diseases or allergic constitution; 3) Patients with history of tuberculosis or latent tuberculosis infection or suspected tuberculosis patients with clinical manifestations (including but not limited to pulmonary tuberculosis), or chest X-ray shows active pulmonary tuberculosis; 4) Plan to receive any monoclonal antibodies or biological drugs within 3 months after the administration of the study drug; 5) Participated in clinical trials of any other drugs or medical devices within 3 months before enrollment, or planned to participate in clinical trials of other drugs or medical devices during the research process; 6) Unable or unable to comply with ward management regulations, poor compliance during the study period, or unable to complete the study according to the program requirements; 7) The subjects were unable to complete the experiment due to personal reasons; 8) The researchers think it is not suitable to be included in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Acne Grading System;Drug tolerability assessment;Dermatology Life Quality Index;Related immunocytokine;Scar Assessment Scale;Acne erythema score; | — |
Secondary
| Measure | Time frame |
|---|---|
| White blood cell count;C-reactive protein; | — |
Countries
China
Contacts
Public ContactYongfeng Chen
Dermatology Hosipital of Southern Medical University
Outcome results
None listed