fibrosing alopecia in a pattern distribution
Conditions
Interventions
Experimental group:Oral administration apremilast
Sponsors
Department of Dermatology, Huashan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Male and female subjects aged 18 to 65 years old (including 18 and 65 years old), and the gender ratio was appropriate; (2)Clinical and biopsy pathology with a clear diagnosis of FAPD; (3) Understand the nature, significance, possible benefits, possible inconvenience and potential risks of the trial in detail before the trial, and voluntarily participated in the clinical trial, could communicate well with the investigators, complied with the requirements of the whole study, and signed the written informed consent; (4)Active phase of FAPD inflammation (scalp erythema/peripilaris>= 1 point).
Exclusion criteria
Exclusion criteria: (1) Patients with other alopecia disorders that may interfere with the progress of clinical trials, including alopecia areata and telogen alopecia, etc; (2) Current systemic or topical use of other PDE-4 inhibitors except apremilast; (3) Any medical condition, including laboratory abnormalities, that would put a subject at unacceptable risk at the time of study entry or interfere with the interpretation of study data; (4) Prior to screening or randomization, participants had a history of suicide attempt or major mental illness requiring hospitalization within the past 3 years; (5) Current malignancy or a history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years (except treated [i.e., cured] basal cell or squamous cell carcinoma in situ of the skin and treated [i.e., cured] cervical intraepithelial neoplasia or cervical carcinoma in situ without evidence of recurrence); (6) Bacterial infections or severe viral/fungal infections requiring oral or injectable antibiotics should resolve within 2 weeks before baseline (week 0). Treatment for such infections had to be completed and the infection resolved before screening, with no new infection or recurrence before the baseline visit; (7) Active tuberculosis or a history of tuberculosis (not cured); (8) Patients had a history of human immunodeficiency virus (HIV) infection; (9) Congenital or acquired immunodeficiency (e.g., common immunodeficiency); (10) Prior treatment with apremilast; (11) Receiving topical therapy (including but not limited to topical corticosteroids, topical tretinoin or vitamin D analogue preparations, tacrolimus, pimecrolimus, dithranol, or traditional Chinese medicine preparations) within 2 weeks before the baseline visit (week 0); (12) Receiving any systemic treatment for FAPD within 4 weeks before the baseline visit (week 0), including but not limited to corticosteroids, MTX, sulfasalazine, tacrolimus, azathioprine, or traditional Chinese medicine preparations; (13) Currently receiving treatment in another investigational device or drug study, or less than 30 days before the end of treatment with another investigational device or drug study. Participation in other research procedures during this study was not included; (14) Positive hepatitis B surface antigen or hepatitis B core antibody at screening; (15) Hepatitis C antibody was positive and hepatitis C virus RNA was detectable at the time of screening; (16) Female subjects of childbearing potential were unwilling to use a protocol-defined contraceptive method from the time they were receiving treatment until 30 days after the last dose of trial product; (17) Women who were lactating or planned to breastfeed during the study until 30 days after the last dose of trial product; (18) Women who plan to become pregnant during the study and within 30 days of the last dose of trial product; (19) Fertile female subjects had a positive result on a highly sensitive urine (day 1) or serum (screening) pregnancy test; (20) Allergic to apremilast; (21) To the knowledge of subjects and investigators, subjects may not be able to complete all study visits or procedures required by the protocol and/or may not be able to follow all prescribed study procedures (e.g., clinical outcome assessments); (22) Previous or documented presence of any other clinically significant disorder, condition, or disease (other than the above) that the investigators believe may endanger the safety of the subjects or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perifollicular cast;Perifollicular erythema;Degree of improvement in scalp paresthesia (itching, tingling, burning); | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective feelings of patients;terminal follicle score; | — |
Countries
China
Contacts
Public ContactWu Wenyu
Department of Dermatology, Huashan Hospital
Outcome results
None listed