NCT03608917

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

Completed NA Last updated 11 March 2021

What this trial tests

NA trial testing Total Glucosides of Paeony(TGP) in Vitiligo in 200 participants. Completed in 31 July 2019.

Timeline

17 April 2018

Primary endpoint
30 April 2019

31 July 2019

Quick facts

Lead sponsor	xjpfW
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	200
Start date	17 April 2018
Primary completion	30 April 2019
Estimated completion	31 July 2019
Sites	1 location across China

Drugs / interventions tested

• Total Glucosides of Paeony(TGP) — full drug profile →
• Narrow band-ultraviolet b（NB-UVB）
• Total Glucosides of Paeony(TGP) analogue — full drug profile →

Conditions studied

• Vitiligo — all drugs for Vitiligo →

Sponsor

xjpfW — full company profile →

Who can join

Adults 18 to 65, any sex, with Vitiligo. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Skin immunity and its dysregulation in atopic dermatitis, hidradenitis suppurativa and vitiligo.
   Campione E, Lanna C, Diluvio L, Cannizzaro MV, et al · · 2020 · cited 32× · PMID 31905036 · DOI 10.1080/15384101.2019.1707455
2. Dysregulated Intracellular Signaling in the Pathogenesis of Vitiligo: An Update on Emerging Therapeutic Strategies.
   Marrapodi R, Marini A, Bellei B. · · 2025 · PMID 41007740 · DOI 10.3390/biomedicines13092177