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Efficacy and safety of hydroxychloroquine sulfate on severe erosive oral lichen planus: a randomized controlled clinical trial

Efficacy and safety of hydroxychloroquine sulfate on severe erosive oral lichen planus: a randomized controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042577
Enrollment
Unknown
Registered
2021-01-23
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-05-03

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

Conditions

oral lichen planus

Interventions

Group A:Hydrochloroquine Sulfate Tablets

Sponsors

West China Hospital of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Aged between 18 and 60 years ; 2.Clinically or pathologically diagnosed as erosive/atrophic oral lichen planus; 3.Acute extensive or multi-focal erosion and the lesion size >= 1cm2; or the total area of hyperemia is > 1cm2. 4.Disease-process exceeding 2 months; 5.Result of a physical and eye-related examination is normal; 6.Negative reaction to a pregnancy test in women; 7.Those who participate in the study independently and sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Those with severe systemic diseases that can not control by medicine; 2.History of allergies to glucocorticoids; 3.Those taking immunotherapy during the previous 3 months; those having topical treatment of lichen planus within a week; 4.Lichenoid disease induced by amalgam or other drugs; 5.Those with other severe mucous diseases; 6.Intention of pregnancy or lactation; 7.Those with history of psychiatric disorders who can not to cooperate.

Design outcomes

Primary

MeasureTime frame
lesion size;pain level;Serum levels of inflammatory factors;

Secondary

MeasureTime frame
healing rate;Incidence of adverse reactions;recurrence rate;RAE score;

Countries

China

Contacts

Public ContactHongmei Zhou

West China College of Stomatology, Sichuan Universityn

acomnet@126.com+86 28-85503480

Outcome results

None listed

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