Non-segmental vitiligo
Conditions
Interventions
RSS0393 ointment plus SHR0302 Base gel group:RSS0393 ointment plus SHR0302 Base gel
SHR0302 Base gel group:SHR0302 Base gel
RSS0393 ointment group:RSS0393 ointment
Sponsors
Suzhou Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participants must be between 18 and 75 years old on the day they sign the informed consent, and can be male or female; 2. Clinically diagnosed with non-segmental vitiligo; 3. Disease has been stable for over 3 months (90 days) (stable disease is defined as no enlargement of existing lesions and no new lesions); 4. At screening and baseline, the affected BSA (Body Surface Area) must meet the following two points at the same time: (1) Facial BSA affected >=0.3%; and (2) Non-facial BSA affected =0.15; 6. Participants agree to stop using all vitiligo-related treatments and any camouflaging cosmetics with therapeutic effects throughout the study (except for non-prescription preparations and cosmetics approved by the investigator); 7. Participants voluntarily sign informed consent before any study-related procedures, can communicate well with the investigators, understand and are willing to strictly follow the requirements of this clinical study to complete it; 8. Female participants of childbearing potential or male participants with partners of childbearing potential must agree to not conceive, donate sperm/eggs from the time of signing the informed consent until 6 months after the last medication, and voluntarily use effective contraception (including for partners).
Exclusion criteria
Exclusion criteria: 1. Having any of the following skin abnormalities or conditions: (1) Participants diagnosed with segmental, mixed, or unclassified vitiligo; or previously diagnosed with other skin pigmentation disorders (such as rashes, leukoderma, pityriasis alba, macular hypomelanosis, achromic nevi, leprosy, post-inflammatory hypopigmentation, nevus anemicus, chemical leukoderma, tinea versicolor, etc.) (except halo nevi); (2) Participants with more than 33% of facial lesions from vitiligo showing white hair, or over 33% of total body lesions showing white hair due to vitiligo; (3) Participants who, during screening or baseline, have other active skin conditions that could interfere with the use of the study drug or evaluation of its efficacy (psoriasis, dermatitis, eczema, acne, atopic dermatitis, dysplastic nevi, morphea, discoid lupus, or other skin lesions, skin ulceration, etc.) or skin infections (bacterial, fungal, viral, etc.); (4) Participants with skin injuries or abnormalities that could affect the assessment of the drug application site, such as dermatitis, tattoos, scars, excess hair, birthmarks, injuries, uneven skin tone, sunburn, etc. 2. Any participant who has taken the following medications or participated in clinical studies (defined as having signed an informed consent form and received at least one treatment with a drug or device): (1) Participants who received any laser or light therapy for vitiligo (including NB-UVB, 308nm excimer light, 308nm excimer laser, sunbeds, etc.) within 4 weeks before baseline; (2) Participants who received oral or systemic medications aimed at controlling/improving vitiligo symptoms within 4 weeks before baseline, including glucocorticoids, drugs that stimulate melanocytes, immunomodulators (cyclosporine, methotrexate, tacrolimus, etc.), or any other systemic treatments that might increase skin sensitivity to UV/visible light or affect skin pigmentation (such as tetracyclines, methoxsalen, etc.); (3) Participants who received topical treatments aimed at controlling/improving vitiligo symptoms within 2 weeks before baseline, including topical glucocorticoids, calcineurin inhibitors (like tacrolimus, pimecrolimus, etc.), and vitamin D3 derivatives (like calcipotriol, tacalcitol, etc.); (4) Participants who received systemic Chinese medicine treatments within 4 weeks before baseline; (5) Participants who took oral JAK inhibitors/PDE4 inhibitors within 4 weeks before baseline, or topical JAK inhibitors/PDE4 inhibitors within 2 weeks before baseline, or those previously unresponsive or intolerant to oral/topical JAK inhibitors/PDE4 inhibitors (as judged by the investigator); (6) Participants who used moderate or strong CYP3A4 inhibitors or inducers (including prescription drugs, over-the-counter drugs, and dietary supplements) systemically within 4 weeks before baseline (see Appendix 11.3 for details); (7) Participants who used any biologics within 12 weeks or 5 half-lives before baseline, whichever is longer; (8) Participants who took part in other interventional clinical studies within 4 weeks before baseline, or who were still within 5 half-lives of the last dose of an interventional study drug at baseline; (9) Participants who have ever used skin depigmentation treatments (such as monobenzyl ether of hydroquinone, monobenzyl ether of hydroxyphenol, etc.); (10) Participants who have previously undergone skin graft treatments. 3. Presence of the following significant medical history or underlying cond
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants achieving at least 50% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI50 response); | — |
Secondary
| Measure | Time frame |
|---|---|
| The absolute and percent change from baseline in the Facial Vitiligo Area Scoring Index (F-VASI);Safety: Adverse events, vital signs, laboratory tests, and 12-lead electrocardiograms;The absolute and percent change from baseline in Facial Body Surface Area (F-BSA);The proportion of participants achieving a Vitiligo Noticeability Scale (VNS) score of 4 ("marked improvement") or 5 ("complete improvement");The proportion of participants achieving at least 50%/75%/90% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI50/75/90 response);The proportion of participants achieving at least 75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI75 response);The proportion of participants achieving at least 90% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI90 response);The absolute and percent change from baseline in the Total Body Vitiligo Area Scoring Index (T-VASI);The proportion of participants achieving at least 50%/75%/90% improvement from baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50/75/90 response);The absolute and percent change from baseline in Total Body Surface Area (T-BSA); | — |
Countries
China
Contacts
Public ContactJun Gu
Suzhou Municipal Hospital
Outcome results
None listed