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A multicenter clinical study on the treatment of acne vulgaris with Longzhu ointment

Randomized, blinded, positive drug parallel controlled, multicenter clinical study of Longzhu ointment in the treatment of moderate acne vulgaris

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085476
Enrollment
Unknown
Registered
2024-06-07
Start date
2024-06-13
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

acne vulgaris

Interventions

Research group :For external use, once a day, in the evening, take an appropriate amount of ointment. After dinner, apply a thin layer of benzoyl peroxide gel simulator to the affected area, wipe the
control group:For external use, once a day, in the evening, take an appropriate amount of ointment. After dinner, apply a thin layer of Longzhu ointment simulant to the affected area, wipe the affecte

Sponsors

Dongfang Hospital of Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Age range from 18 to 50 years old, regardless of gender; 2. According to the PILLSBURY international improved classification system, patients clinically diagnosed with acne vulgaris grades II-III have facial features that meet the following criteria: 20-50 inflammatory skin lesions (papules, pustules, and nodules), 25-100 non inflammatory skin lesions (open and closed acne), no more than 2 facial nodules, and an IGA score of moderate; 3. The subject agrees to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who are known to be allergic to any component in Longzhu Ointment (artificial musk, borax, calcined calamine, ammoniacal ammonia, borneol, artificial bezoar, pearl (made), amber, and the auxiliary materials are yellow vaseline, lanolin, liquid paraffin) and any component in peroxybenzoyl gel, or the allergic body is not suitable for participating in this study after evaluation by the researcher; 2. Patients with facial complications and other skin diseases that may significantly affect the efficacy evaluation, such as sunburn dermatitis, hormone dependent dermatitis, rosacea, psoriasis, seborrheic dermatitis, eczema, etc; 3. Patients who have used topical acne treatment drugs within the first 2 weeks of the study, or those who have taken antibiotics, retinoids, and other acne treatment drugs orally within 4 weeks; 4. Having excessive facial hair (such as beard, sideburns, etc.) may interfere with the diagnosis and evaluation of acne vulgaris; 5. Patients who received photodynamic therapy within the first three months of the study; 6. Pregnant or women preparing for pregnancy and lactation within six months; 7. Participants in other clinical trials within the first three months prior to the start of this study; 8. The researchers believe that due to other reasons, it is not suitable for participants to participate in the trial.

Design outcomes

Primary

MeasureTime frame
On the 8th and 15th day of medication, the percentage change in inflammatory skin lesion counts (erythema, pustules, and papules) compared to baseline values in each group after treatment;;Comparison of percentage changes in inflammatory skin lesion count before and after treatment between the study group and the control group on the 8th and 15th day of medication;

Secondary

MeasureTime frame
On the 8th and 15th day of medication, the researcher determined that IGA treatment was successful, and the difference between the study group and the control group;On the 8th and 15th day of medication, there was a difference in the percentage change in non inflammatory skin lesion count (nILC) between the study group and the control group compared to baseline.;

Countries

China

Contacts

Public Contactfengchuan zhang

Dongfang Hospital of Beijing University of Traditional Chinese Medicine

bjzfc@sina.com+86 139 0110 3592

Outcome results

None listed

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