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

NCT ID: NCT03608917

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-17
• Study Completion Date: 2019-07-31

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.

Conditions

Vitiligo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment group

Drug:Total Glucosides of Paeony (TGP)

1. Time Frame: Week0-week8 The 1st Week, TGP 0.6g , Bid, orally; 2nd to Week8 , TGP 0.6g , Tid, orally combined with NB-UVB phototherapy( 1 time every other day)

2. Time Frame: Week9-Week24 TGP, 0.6g, Tid, orally.

Group Type: EXPERIMENTAL

Total Glucosides of Paeony(TGP)

Intervention Type: DRUG

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）

Narrow band-ultraviolet b（NB-UVB）

Intervention Type: DEVICE

phototherapy on treating vitiligo

Control group

Drug:Total Glucosides of Paeony (TGP) analogue

1. Time Frame:Week0-week8 The 1st Week, TGP analogue 0.6g , Bid, orally; 2nd to Week8, TGP analogue (0.6g , Tid, orally) combined with NB-UVB phototherapy( 1 time every other day)

2. Time Frame: Week9-Week24 TGP analogue, 0.6g, Tid, orally.

Group Type: PLACEBO_COMPARATOR

Narrow band-ultraviolet b（NB-UVB）

Intervention Type: DEVICE

phototherapy on treating vitiligo

Total Glucosides of Paeony(TGP) analogue

Intervention Type: DRUG

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

Interventions

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）

Intervention Type: DRUG

Narrow band-ultraviolet b（NB-UVB）

phototherapy on treating vitiligo

Intervention Type: DEVICE

Total Glucosides of Paeony(TGP) analogue

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force General Hospital of the PLA

OTHER_GOV

Sponsor Role: collaborator

First Hospital of China Medical University

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

xjpfW

OTHER

Sponsor Role: lead

Responsible Party

xjpfW

Head of Dermatology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tianwen Gao, Prof

Role: PRINCIPAL_INVESTIGATOR

Dermatology Derpartment of Xijing Hospital

Locations

Xijing Hospital

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

XijingH-PF-20180116

Identifier Type: -

Identifier Source: org_study_id