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Clinical study of the treatment of actinic cheilitis using Rothia mucilaginosa-derived membrane vesicles

Clinical study of the treatment of actinic cheilitis using Rothia mucilaginosa-derived membrane vesicles

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100015
Enrollment
Unknown
Registered
2025-04-01
Start date
2025-02-15
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Actinic Cheilitis

Interventions

Control group:Vaseline treatment
Test group:Treatment using Vaseline containing membrane vesicles derived from Rothia mucilaginosa

Sponsors

The Third Affiliated Hospital of PLA Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Male participants aged 18-40 years; 2. In good general health and available for examinations throughout the trial period; 3. Actinic cheilitis classified as Grade II or above according to the Rubem clinical grading criteria (AC Grade I: Dryness and desquamation of the lip vermilion; AC Grade II: Atrophy of the lip vermilion, pallor, accompanied by erosion; AC Grade III: Hyperkeratosis of the lip vermilion, rough desquamation, with spread of the lesion to the oral mucosa or perioral skin; AC Grade IV: Ulceration or leukoplakia occurring at one or more sites of the lips); 4. Voluntary participation and signing of an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Participants have other severe oral, skin, or systemic diseases; 2. Currently or within the past month, received cheilits medications, surgery, or laser therapy; 3. Within one month before participating in the study, use of the following medications: hormonal medications, immunosuppressants, antihistamines, antibiotics, sedatives, etc; 4. A history of allergies to food, medications, cosmetics, or probiotic preparations, or a history of idiosyncratic reactions; 5. Participation in other clinical trials within the past month; 6. Habits of smoking, betel nut chewing, gum chewing, or alcohol consumption.

Design outcomes

Primary

MeasureTime frame
Lip vermilion Trans-Epidermal Water Loss (TEWL);Actinic cheilitis clinical grade;

Secondary

MeasureTime frame
Complete blood count;Serum C-reactive protein concentration;Liver function test;Kidney function test;

Countries

China

Contacts

Public ContactKun Xuan

Department of Preventive Dentistry, School of Stomatology, The Fourth Military Medical University.

xuankun@fmmu.edu.cn+86 135 7209 9737

Outcome results

None listed

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