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A randomized, double-blind and positive drug parallel control experiment on the effectiveness and safety of 5-Fluorouracil in the treatment of acne

A randomized, double-blind and positive drug parallel control experiment on the effectiveness and safety of 5-Fluorouracil in the treatment of acne - A Randomized Controlled Clinical Trial of 5-Fluorouracil for the Treatment of Acne

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084642
Enrollment
Unknown
Registered
2024-05-22
Start date
2024-05-24
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Acne

Interventions

Treatment group:5-Fluorouracil
Control group:Type A botulinum toxin

Sponsors

Plastic Surgery Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age 18 to 65 (included) years old, no gender restriction; (2) Diagnosed with facial acne; (3) Voluntarily join this trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with a history of healing disorders or keloid scars. (2) Patients known to have systemic infections or local infections at the intended treatment site. (3) Patients with a history of immunosuppression/immunodysfunction (including HIV infection or AIDS) or taking immunosuppressive drugs. (4) Patients who have had sunburn within the past month. (5) Patients who have received surgical treatment in the intended treatment area within the past month, including: minimally invasive, plastic surgery, phototherapy, intense pulsed light, laser, radiofrequency treatment. (6) Patients who have taken or are taking anticoagulants or drugs that affect wound healing within the past month. (7) Patients who have taken or are taking or have applied minocycline, isotretinoin, and other acne treatment drugs within the past month. (8) Currently suffering from epilepsy, emotional disorders or cognitive disorders who cannot cooperate with treatment. (9) Pregnant women, breastfeeding women, or those who plan to become pregnant or give birth during the trial period. (10) Those who have participated in other interventional clinical trials within the past month. (11) Other situations where the researcher believes it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Effectiveness of treatment;

Secondary

MeasureTime frame
Treatment Efficacy;Global Aesthetic Improvement Scale;Satisfaction Questionnaire;

Countries

China

Contacts

Public ContactJintian Hu

Plastic Surgery Hospital, Chinese Academy of Medical Sciences

hujintian@vip.163.com+86 138 1012 4940

Outcome results

None listed

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