Efficacy and Safety of Total Glucosides of Paeony Combined With NB-UVB on Treating Vitiligo

Vitiligo Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608917
• Other study ID #: XijingH-PF-20180116
• Status: Completed
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2021
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• Total Glucosides of Paeony(TGP)
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.TGP is new drug of western medicine, original discovered by Professor Xu who is a famous pharmacologist. 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)

Device:
• Narrow band-ultraviolet b(NB-UVB)
phototherapy on treating vitiligo

Drug:
• Total Glucosides of Paeony(TGP) analogue
Total Glucosides of Paeony(TGP) analogue as a placebo for Control group

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (4)

Lead Sponsor	Collaborator
xjpfW	Air Force General Hospital of the PLA, Chinese Academy of Medical Sciences, First Hospital of China Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitiligo Area and Severity Index (VASI)	The extent of residual depigmentation is expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. The VASI for each body part is the product of the palm unit and the degree of depigmentation of the unit.VASI=Sall body sites (hand units) × depigmentation	Change from Baseline VASI at 24 weeks
Secondary	The number of recovered vitiligo area	The number of recovered vitiligo area	8 weeks