seborrheic dermatitis
Conditions
Interventions
Experimental group 1:TAP-1502 Spray (0.5%)
Experimental group 2:TAP-1502 Spray (1%)
Control group:Placebo
Experimental group (Phase 2):TAP-1502 Spray
Control group (Phase 2):Placebo
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 and above, male or female; 2. The patient was clinically diagnosed as seborrheic dermatitis and had been diagnosed for at least 3 months before the screening visit, and the condition was stable within the past 4 weeks; 3. Seborrheic dermatitis skin affected body surface area = 20%; 4. Baseline IGA2 =3 scores; 5. Baseline erythema global score and scale global score were = 2 points; 6. Women of childbearing age who have reproductive potential (including women who have menarche and do not meet the criteria for no reproductive potential) have a negative blood pregnancy test at baseline screening and agree to use effective contraception during the study period. A female subject with no reproductive potential must meet at least one of the following criteria: (1) Be postmenopausal, defined as having stopped menstruating for at least 12 consecutive months without other pathological or physiological causes; (2) Have undergone hysterectomy and/or bilateral oophorectomy, and have documented; (3) Medically confirmed ovarian failure; 7. Fully understand the content of the experiment, voluntarily participate in the experiment, and have signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with severe diseases of central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, metabolism and bone marrow muscle system; 2. Serum Alanine Aminotransferase (ALT), Aspartate Transarninase (AST) in liver function were 2 times higher than the upper limit of normal. Or serum creatinine level of renal function is 1.5 times higher than the upper limit of normal value; 3. Human immunodeficiency virus infection, hepatitis C virus infection active period (anti-HCV positive), hepatitis B virus infection active period (HBV-DNA > 2000 IU/mL or 104 copies /ml) or treponema pallidum antibody positive; 4. Pregnant women, breastfeeding women, women with pregnancy plans; 5. People who are known to be allergic to the active ingredient or excipient of the investigational drug; 6. Participants who have participated in clinical trials of any other drug within 3 months prior to the first dose; 7. Screening of persons with a history of drug abuse/dependence in the preceding 12 months; 8. There are other serious skin diseases or skin problems in the affected area that researchers believe may hinder the evaluation of seborrheic dermatitis, such as the presence of clear skin bacterial infection, viral infection, parasitic infection, psoriasis, atopic dermatitis, or the presence of pigmentation, extensive scarification, pigmentary lesions, sunburn, etc.; 9. Have a history of malignant cancer or have been treated for any type of malignant cancer within the last 5 years (except for skin squamous cell carcinoma, basal cell carcinoma or skin carcinoma in situ that has been cured by cryotherapy or surgical excision); 10. The washout period of patients who received biologics before baseline visit and did not reach 12 weeks or 5 half-lives of drugs after medication (the longer period is taken as the washout period); 11. Patients who had received phototherapy, sunbathing or systemic treatment known to affect seborrheic dermatitis (including systemic antifungal drugs, glucocorticoids, retinoic acid, immunosuppressants, phosphodizyme 4 inhibitors, traditional Chinese medicine, etc.) within 4 weeks before baseline visit; 12. Those who had received topical medication for scalp outside seborrheic dermatitis (e.g. Topical minoxidil for androgenic alopecia, etc.) within 4 weeks prior to baseline visit; 13. Those who had received any topical treatment (including topical antifungal drugs, glucocorticoids, calcineurin inhibitors, sulfur containing drugs, phosphodizyme 4 inhibitors, azelaic acid, metronidazole, etc.) that could affect seborrheic dermatitis within 2 weeks prior to baseline visit; 14. Subjects who plan to undergo natural/artificial UV exposure (sunbathing, UV phototherapy) during the study; 15. The subject may not be able to complete the study for other reasons, or the investigator considers it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with an IGA of 0 or 1 and a decrease of at least 2 points from baseline (IGA response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| IGA response rate;Percentage change in IGA from baseline;Percentage of patients with an IGA score of 0;Percentage of subjects with baseline WI-NRS score =4 and post-treatment improvement =4 (WI-NRS4 response rate);Percentage change in WI-NRS from baseline;Percentage of patients with an overall erythema score of 0;Percentage of patients with an overall scale score of 0; | — |
Countries
China
Contacts
Public ContactJianzhong Zhang
Peking University People's Hospital
Outcome results
None listed