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clinical trial of a long-term intermittent treatment of 0.05% fluticasone propionate cream to prevent recurrence of vitiligo

clinical trial of a long-term intermittent treatment of 0.05% fluticasone propionate cream to prevent recurrence of vitiligo

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031143
Enrollment
Unknown
Registered
2020-03-23
Start date
2020-05-05
Completion date
Unknown
Last updated
2021-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vitiligo

Interventions

Control group:Fluticasone propionate cream was used as a placebo for topical treatment once every Saturday and Sunday, and the duration of administration for 12 months.
Experimental group 1:Topical rubbing with 0.05% fluticasone propionate cream (15g / stick, Aramco Pharmaceutical Co., Ltd., the same below), topical application once every Saturday and Sunday, maintai
Experimental group 2:Topical rubbing with 0.05% fluticasone propionate cream, topical application once every Saturday and Sunday, maintaining medication for 6 months.
Experimental group 3:Topical rubbing with 0.05% fluticasone propionate cream, topical application once every Saturday and Sunday, maintaining medication for 12 months.

Sponsors

Dermatology Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of stable vitiligo: (1) VIDA points0 point VIDA scoring standardAccording to the time of new lesions appearance or expansion of the original lesionsappeared in the last 6 weeks + 4 pointsappeared in the last 3 months + 3 pointsappeared in the last 6 months + 2 pointsappeared in the last 1 year + 1 pointhave a stable period for at least 1 year0 pointHave a stable period for at least 1 year and have spontaneous pigment regeneration -1 pointThe total score > 1 point is the advanced period>=4 is divided into rapid progress period; (2) Clinical featuresWhite spots are porcelain white with clear edges or pigmentation; (3) Homomorphic reactionNo homomorphic reaction occurred within one year. The homomorphic reaction refers to the appearance of white spots in the skin injury site within 1 year. The damage can be physical (wound, cut, scratch, mechanical friction, permanent compression, thermal burn, freezing injury), chemical, allergic (allergic contact dermatitis) or other inflammatory skin diseases, irritating reactions (vaccination, tattoos, etc.), therapeutic (radiation therapy, phototherapy), etc.; (4) Wood lampThe color of the skin lesion is white, the boundary is clear, and the area of the skin lesion under the Wood lamp <=the visual area; 2. The skin lesions with more than 80% color reproduction after treatment in patients with stable non-segmental vitiligo were selected as observation objects; 3. The patient informed and agreed to participate in the study. 4. Aged 6 and 60 years old.

Exclusion criteria

Exclusion criteria: 1. Progressive vitiligo; 2. Limb, segmental and pan-type vitiligo; 3. Spontaneous color reproduction skin lesion; 4. With mental abnormality; 5. With serious illnesssuch as severe heart, brain, liver, kidney and other systemic diseases, or malignant tumors 6. Allergic to fluticasone propionate; 7. Patients who have been using systemic immunosuppressive drugs or systemic UV therapy for the past month; 8. Patients who have participated in other clinical trials in the last 3 months; 9. Other circumstances that the investigator believes are not suitable for this study.

Design outcomes

Primary

MeasureTime frame
area of depigmentation;

Secondary

MeasureTime frame
Skin condition;

Countries

China

Contacts

Public ContactGuangpu Luo
102931@163.com+86 13926166004

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026