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A single-arm clinical trial and an open-label stratified randomized controlled clinical trial of the two-in-one external treatment method of traditional Chinese medicine (millimeter fire needle - bloodletting from skin lesions) for acne

A single-arm clinical trial and an open-label stratified randomized controlled clinical trial of the two-in-one external treatment method of traditional Chinese medicine (millimeter fire needle - bloodletting from skin lesions) for acne

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002618
Enrollment
Unknown
Registered
2025-12-30
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

acne

Interventions

Single-arm clinical trial - Level I:Fire needle - skin lesion bloodletting combined external treatment, once a week, for a total of 4 treatments.
Single-arm clinical trial - Level II:Fire needle - skin lesion bloodletting combined external treatment, once a week, for a total of 4 treatments.
Single-arm clinical trial - Level III:Fire needle - skin lesion bloodletting combined external treatment. 0-1 week: twice a week
2-3 weeks: once a week. A total of 6 treatments.
Single-arm clinical trial - Level IV:Fire needle - skin lesion bloodletting combined external treatment. The treatment was given twice a week for a total of 8 times.
Control group - Level I:Red and blue light, once a week, for a total of 4 treatments.
Control group - Level II:Red and blue light, once a week, for a total of 4 treatments.
Control group - Level III:Take the Oral Moisturizing and Soothing Antipruritic Capsules (3 times a day, 4 capsules each time (0.5g per capsule), 6g per day) for 4 weeks. Use red and blue light for 0-1
Control group - Level IV:Take doxycycline orally at a dose of 100 mg per day for 2 consecutive weeks. Take Danshen Dihuan Capsules orally (3 times a day, 4 capsules each time (0.25g per capsule), 3g p
Traditional Chinese Medicine External Treatment Group - Level I:Fire needle - skin lesion bloodletting combined external treatment, once a week, for a total of 4 treatments.
Traditional Chinese Medicine External Treatment Group - Level II:Fire needle - skin lesion bloodletting combined external treatment, once a week, for a total of 4 treatments.
Traditional Chi

Sponsors

The Second Affiliated Hospital of Hunan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 40 Years

Inclusion criteria

Inclusion criteria: a. Age range: 16 to 40 years old, gender not restricted. b. Clinically diagnosed with common acne, with severity classified as mild to moderate (I-IV grades). Acne grade III in traditional Chinese medicine diagnosis is characterized by damp heat in the spleen and stomach, and acne grade IV is characterized by stasis and blood stasis accumulation. c. Those who have received conventional acne treatment but with poor results, or those whose condition recurs frequently, or those who cannot take oral medications for various reasons. d. Two weeks before enrollment, no conventional acne treatment (medication or physical therapy) was used. During the study period, no other drugs or therapies for treating acne were used. e. No participation in other clinical trials within 3 months before enrollment and during the study period. f. The patient has fully understood the study protocol, possible risks, and postoperative care requirements. g. Informed consent, voluntary participation, regular follow-up and consultation, authorization for the use of desensitized diagnosis and imaging data for teaching and research, and signing of the informed consent form.

Exclusion criteria

Exclusion criteria: a. Special types of acne, such as severe conglobate acne, fulminant acne, etc. b. Pregnant women or those planning to become pregnant in the near future. c. Those with severe organic diseases, systemic diseases, mental disorders, or other diseases that the researchers consider unsuitable for inclusion in the study. d. Those with a scar-prone constitution or a history of hypertrophic scars or keloids. e. Those with bleeding disorders, or those using anticoagulant or antiplatelet drugs. f. Those with a clear history of allergy to iodophor, alcohol, acidic preparations, metal needles or excipient ingredients. g. Those who cannot cooperate with treatment for various reasons or do not wish to follow up and visit the doctor regularly. h. Those with abnormal liver and kidney functions.

Design outcomes

Primary

MeasureTime frame
Global Acne Grading System (GAGS) score;The Global Acne Grading System (GAGS) improvement;Adverse event;

Secondary

MeasureTime frame
The Global Acne Grading System (GAGS) improvement;Improvement rate of the Global Acne Grading System (GAGS);Treatment effectiveness rate;Improvement rate of lesion count;Improvement rate of lesion score;CBS Cloud Mirror Detection;Skin physicochemical index difference;No recurrence period;recurrence rate;

Countries

China

Contacts

Public ContactWang Haizhen

The Second Affiliated Hospital of Hunan University of Chinese Medicine

491476160@qq.com13873165440

Outcome results

None listed

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