The anti-inflammatory effect of Keigai-rengyo-to extract and acupuncture in male patients with acne vulgaris: a randomized controlled pilot study

INTERVENTION: Drug, Medical Device : 1. Keigai‐rengyo‐to extract: We purchase Keigai‐rengyo‐to extract from the Han Kook Sin Yak Pharm. Co. Ltd which equipped Korean good manufacturing practice (KGMP) facility. This herbal medicine is approved by Korea Food and Drug Administration and use in clinical practice for acne, sinusitis and otitis media.We prescribe patients this herbal medicine every 7.4g 3 times a day after meals for 4 weeks. 2. Acupuncture: Acupuncture is performed by a licensed oriental medical doctor who had 3 years of clinical experience obtained after a 6‐year oriental medical college course. Disposable stainless steel acupuncture needles (0.25×30mm, Dongbang Acupuncture, Korea) are used. No specific needle stimulation techniques are used and no specific response is obtained like De‐Qi (??). The needles are inserted at a vertical or oblique angle to a depth of 3±2 mm at each acupuncture point in acupuncture only and Keigai‐rengyo‐to extract+acupuncture combined therapy group, to minimize pain and retain in place for 15 min. The papules and nodules are not artificially extruded. Patients receive acupuncture at 22 classical acupuncture points and/or ah shi points randomly selected at papules and nodules on the face by the acupuncture practitioner. The following 22 classical acupuncture points are treated bilaterally: ST2(??), ST6(??), ST36(???), LI20(??), LI11(??), PC6(??), HT8(??), SP3(??), SP6(???), SP10(??) and LR3(??). These points were selected based on previous studies of acupuncture treatment of acne vulgaris and from the doctor’s clinical experience and oriental medical classics. Participants remain in supine position throughout each session. Patients recieve acupuncture twice a week for 4 weeks. CONDITION: Diseases of the skin and subcutaneous tissue PRIMARY OUTCOME: the percentage change of acne inflammatory lesions between baseline and end of trial SECONDARY OUTCOME: IGA(investigator Global Assessment; from score 1 (very good) to 5 (very poor) Skindex‐29 (quality of life in patients with skin disease) the count of inflammatory lesions the count of non‐inflammatory lesions the percentage change of acne non‐inflammatory lesions between baseline and end of trial VAS (Visual Analogue Scale; score 0 (no symptom) to 100 (sever symptom) INCLUSION CRITERIA: 1. Participants are between 13 to 35 years old in male 2. They have more than 10 papules and less than 20 nodules on the face ( Korean Acne Grading System grade 2 to 4) 3. They have had acne for more than 3 months (chronic stage).