Vitiligo
Conditions
Interventions
Experimental Group:Qibai Granule
Control Group:Qibai Granule Simulator
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Adults aged 18-65 years; 2) History of previously diagnosed vitiligo for at least 3 months; 3) The diagnosis of traditional Chinese medicine is vitiligo of meridian stasis and spleen-stomach deficiency pattern; 4) Modern medical diagnosis is non-segmental vitiligo; 5) Disease progression or new skin lesions within the last 6 months. The area of vitiligo on the face and neck is greater than 0.5% BSA and the total body vitiligo area not exceeding 30% BSA; 6) Participants who agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit; 7) Ability to comprehend and willingness to sign informed consent form.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: 1) Other forms of vitiligo (eg segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg piebaldism pityriasis alba leprosy postinflammatory hypopigmentation progressive macule hypomelanosis nevus anemicus chemical leukoderma and tinea versicolor). 2) Participants who have used depigmentation treatments for past treatment of vitiligo or other pigmented areas. 3) Participants with concurrent conditions and history of other diseases: a. Any other skin disease that in the opinion of the investigator would interfere with the study medication application or study assessments. b. Active acute bacterial fungal or viral skin infection (eg herpes simplex herpes zoster chicken pox) within 1 week before baseline. c. Conditions at baseline that would interfere with evaluation of vitiligo. d. Any serious illness or medical physical or psychiatric condition(s) that in the investigator's opinion would interfere with full participation in the study including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. 4) Participants who had previously used Qibai granules or similar drugs within 3 months. 5) Participants using any of the following treatments within the indicated washout period before baseline: a. 1 week: Topical drugs when used on the vitiligo areas for example corticosteroids calcineurin and phosphodiesterase type 4 inhibitors or retinoids. b. 4 weeks: - Melanocyte-stimulating agents (eg afamelanotide). - Immunomodulating systemic medications (eg corticosteroids methotrexate cyclosporine). - Any other systemic therapies that could increase the skin sensitivity to UV/visible light or impact skin pigmentation for example tetracyclines metoxypsoralens. - Received live vaccine. Note: Live vaccine is prohibited during the course of the study and within 4 weeks after the EOT visit. c. 8 weeks: Laser or any kind of phototherapy including tanning bed or intentional UV exposure. d. 5 half-lives or 12 weeks whichever is longer: Biologic agents investigational or experimental therapy or procedures for vitiligo. 6) Participants with clinically significant abnormal laboratory values at screening: ALT or AST>3.0×ULN; TBIL>2.0×ULN; PLT 40 kg/m2. 10) Pregnant or lactating participants or those considering pregnancy during the period of their study participation. 11) Participants who in the opinion of the investigator are unable or unlikely to comply with the administration schedule and study evaluations. 12) Trial researchers or their family members. 13) Participants who are participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vitiligo Disease Activity score;Vitiligo Area Scoring Inde; | — |
Secondary
| Measure | Time frame |
|---|---|
| Biomarker;Body Surface Area;Vitiligo Area Scoring Inde(FN-VASI/T-VASI 25/50/75/90/100);Traditional Chinese Medicine Syndrome Score;T-Cell Subset Test;Vitiligo Signs of Activity; | — |
Countries
China
Contacts
Public ContactChunlai Ma
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed