Clinical trial NCT03608917: Efficacy and Safety of Total Glucosides of Paeony Combined With NB-UVB on Treating Vitiligo
Official title: Efficacy and Safety of Total Glucosides of Paeony Combined With NB-UVB in the Treatment of Sporadic Vitiligo in Proceeding: a Double-blind, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitiligo
Keywords: Vitiligo
Total Glucosides of Paeony(TGP)
narrow-band ultraviolet B (NB-UVB)
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Air Force General Hospital of the PLA
name: First Hospital of China Medical University
name: Chinese Academy of Medical Sciences
First posted: 2018-08-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Total Glucosides of Paeony(TGP) As a traditional Chinese medicine, peony root is the dried root of peony of Ranunculaceae, cultivated all over the country.The main ingredient is a group of glycosides, including paeoniflorin, hydroxy paeoniflorin, paeoniflorin, paeoniflorin, benzoyl paeoniflorin etc, collectively referred to as total glucosides of paeony（TGP）. Paeoniflorin accounted for more than 90% of the TGP, is the main active ingredient of white peony root.By pharmacological and clinical studies of TGP, it have found that the mechanism of TGP is unique and mainly acts on the upstream of the immune response - inhibiting the presentation of antigens. It is different from immunosuppressive agents on T, B lymphocytes, or hormones and other drugs acting on the whole process.
2. Vitiligo Vitiligo is a pigment deprived skin disease caused by the destruction of melanocytes, the global incidence of about 1%. The pathogenesis is not yet clear, the current study shows that oxidative stress and autoimmunity is an important part of its occurrence and development.
3. The basic and clinical research of TGP used in vitiligo The ratio of cluster of differentiation 4+ / cluster designation 8+ T cell vs. cluster of differentiation 4+ chronotropic dose 25+ in the peripheral blood of patients with vitiligo could be significantly increase, after patients treatment by TGP combined with tacrolimus. Thereby enhancing the patient's maintenance of immune self-stability and Immune tolerance ability, promoting the healing of skin lesions. It showed significant effect in stable vitiligo,when patients treated by autologous epidermal grafting combined with TGP.


Eligibility criteria: Inclusion Criteria:

* subjects must be clinically diagnosed by the investigator to have sporadic Vitiligo in proceeding
* Vitiligo with at least 3 depigmented areas in different anatomy areas including：1%\~50% of the total body surface area (BSA) in （face /trunk/limbs）,the minimum area is greater than 1 cm2 .Males or females, 18 Years to 65 Years of age at the time of signing the informed consent document.

.Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.

Exclusion Criteria:

* Actively spreading vitiligo,or stable vitiligo;
* Subjects with segmental, acromegaly, mucous, generalized, mixed and undetermined vitiligo.;
* Secondary vitiligo subjects with history of UV photosensitivity
* Subjects with other diseases unsuitable for ultraviolet light therapy and TGP ; .Use of vitiligo topical drugs within 2 weeks or, system treatment and phototherapy for the treatment of vitiligo within four weeks.
* History of allergy to any component of the total glucosides of paeony(TGP);
* Subjects with a history of chronic diarrhea or peptic ulcer within 1 year .Women who are pregnant or breast feeding,or preparing for pregnancy. .Subjects with serious medical diseases or history of mental system abnormal. .Use of any prior and concomitant therapy not listed above that may interfere with the objective of the study as per discretion of the investigator.

Primary outcomes:
measure: Vitiligo Area and Severity Index (VASI)
timeFrame: Change from Baseline VASI at 24 weeks
Secondary outcomes:
measure: The number of recovered vitiligo area
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Dermatology Derpartment of Xijing Hospital
name: Tianwen Gao, Prof
role: PRINCIPAL_INVESTIGATOR
References: