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

Not Applicable
Completed
Conditions
Diseases of the skin and subcutaneous tissue
Registration Number
KCT0000071
Lead Sponsor
KyungHee University Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Male
Target Recruitment
44
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).

Exclusion Criteria

Participants will be excluded for the following reasons:
1) they have used western treatment such as retinoids, antibodies, chemical peeling, intense pulsed light or laser treatment, or traditional Chinese medical treatment such like herbal medicine or acupuncture within 1 month before entry;
2) on screening via blood test, they do not meet the normal range (hemoglobin=10g/dl, platelet=100000/mm3, AST, ALT=40 IU/L, Bun>30mg/dl and Creatinine>1.2mg/dl);
3) they have papules or nodules mainly located on the chest or back;
4) they have keloid acne, corticosteroid acne, or other infectious skin disease;
5) they have internal disease that required treatment without delay;
6) they are unable to comply with the study guidelines.

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
the percentage change of acne inflammatory lesions between baseline and end of trial
Secondary Outcome Measures
NameTimeMethod
the percentage change of acne non-inflammatory lesions between baseline and end of trial;the count of inflammatory lesions;the count of non-inflammatory lesions;Skindex-29 (quality of life in patients with skin disease);VAS (Visual Analogue Scale; score 0 (no symptom) to 100 (sever symptom);IGA(investigator Global Assessment; from score 1 (very good) to 5 (very poor)
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