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Efficacy and Safety of Hydroxychloroquine in the Treatment of Recurrent Oral Ulceration: A Randomized Controlled Trial

Efficacy and Safety of Hydroxychloroquine in the Treatment of Recurrent Oral Ulceration: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127231
Enrollment
Unknown
Registered
2026-06-26
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Recurrent Oral Ulcer(ROU), also known as Recurrent Aphthous Ulcer (RAU)

Interventions

Experimental Group:Receive oral hydroxychloroquine
Control group:Receive oral prednisone treatment

Sponsors

West China Hospital of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 65 years; 2.With a history of oral ulcers lasting more than 6 months and an ulcer recurrence interval of no more than 2 days; 3.No improvement in ulcer recurrence interval after previous topical medication treatment; 4.No obvious improvement in recurrence interval following prior oral glucocorticoid therapy; 5.Normal blood pressure, pulse, respiration, body temperature and electrocardiogram. 6.All participants voluntarily enroll in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Those with hypersensitivity to hydroxychloroquine or glucocorticoids; 2.Patients with abnormal ophthalmological examination, routine blood test, liver or renal function results; 3.Pregnant women, lactating women and subjects with current pregnancy plans; 4.Patients complicated with severe systemic diseases, including a history of ocular fundus disorders, diabetes mellitus, hematological diseases, cardiovascular diseases, hepatic disorders, renal insufficiency, rheumatic diseases and other related conditions; 5.Subjects receiving systematic therapy within 3 months or topical treatment within 2 weeks; 6.Patients unable to complete study follow-up (e.g., hospitalization, mental disorders, poor treatment compliance);

Design outcomes

Primary

MeasureTime frame
Recurrence interval of ulcer;

Secondary

MeasureTime frame
Days of ulcer healing;The number of ulcers;Numeric rating scale;

Countries

China

Contacts

Public ContactHongmei Zhou

West China Hospital of Stomatology, Sichuan University

acomnet@126.com+86 28 85503480

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026