Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is designed to evaluate the efficacy of different frequencies in treating the moderate and severe acne vulgaris using acupuncture combined with moving cupping and ear point tapping.
Background: Acne vulgaris is a common skin disease, especially in adolescents and young adults. Acne affects approximately 85% of teenagers, but can occur in most age groups and can persist into adulthood. There is no mortality associated with acne, but there is often significant physical and psychological morbidity. Acupuncture combined with moving cupping and ear point tapping may effectively relieve the skin lesions, but the evidence is limited. Also, young patients usually have no time to see the doctor frequently, thus it's necessary to figure out a better frequency of treating.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 times per week therapeutic frequency | Experimental | 1.Acupuncture: GV20, LU5, LI11, LI4,GV14,BL13, ST2, BL2,ST7,ST6 and ashi point on the face.
|
|
| 1 time per week therapeutic frequency | Active Comparator | The acupoints and treating procedures will be the same as the 3 times per week group. Only treating frequency is different. The treating frequency is 1 time per week.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 times per week therapeutic frequency | Procedure | Participants will receive acupuncture, moving cupping and ear-tapping procedure 3 times per week over the 6 weeks period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| IGA success rate | The proportion of subjects who achieved at least a two-point reduction from baseline to week 6 in IGA(Investigator's Global Assessment, scale from 0 to 5) score | Baseline, week 1-6 |
| Measure | Description | Time Frame |
|---|---|---|
| The change of IGA (Investigator's Global Assessment) score from baseline | After 6 weeks treating, the IGA(Investigator's Global Assessment, scale from 0 to 5) score's change from baseline. | Baseline, week 6, week 18, week 30 |
| The change of the Visual Analogue Scale (VAS) for facial pruritus from baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other types of acne: acne conglobate, acne fulminans，acne medicamentosa, premenstrual acne，cosmetic acne and trade acne.
Presence of any other systemic disease that could affect the acne severity by its presence, such as polycystic ovarian syndrome, or thyroid diseases, or atypical congenital adrenal hyperplasia；or by any medication prescribed for the treatment of the systemic diseases.
-- Use of any topical acne treatment or systemic antibiotics or traditional Chinese medicine within 2 weeks before study initiation. Use of a systemic retinoid within 9 months before study initiation. Use of a systemic steroid within 9 months before study initiation. Presence of any change in the use of oral contraceptive pills or anti-inflammatory drugs within 3 months before study initiation.
Presence of any other skin disease that could interfere with the assessment of the acne, such as folliculitis or rosacea.
Presence of severe heart, liver, kidney or hematopoietic system diseases, as well as severe malnutrition.
Pregnancy or lactation.
Recent use of this research scheme within 4 weeks before study initiation.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Xie, Bachelor | Contact | +86 13261958032 | craby616@163.com | |
| Zhishun Liu, Doctor | Contact | 010-88002331 | liuzhishun@aliyun.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9248884 | Background | Doshi A, Zaheer A, Stiller MJ. A comparison of current acne grading systems and proposal of a novel system. Int J Dermatol. 1997 Jun;36(6):416-8. doi: 10.1046/j.1365-4362.1997.00099.x. No abstract available. | |
| 24930587 | Background | Song BH, Lee DH, Kim BC, Ku SH, Park EJ, Kwon IH, Kim KH, Kim KJ. Photodynamic therapy using chlorophyll-a in the treatment of acne vulgaris: a randomized, single-blind, split-face study. J Am Acad Dermatol. 2014 Oct;71(4):764-71. doi: 10.1016/j.jaad.2014.05.047. Epub 2014 Jun 12. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 time per week therapeutic frequency | Procedure | Participants will receive acupuncture, moving cupping and ear-tapping procedure 1 time per week over the 6 weeks period. |
|
VAS uses a 100-mm line that is labeled at each end, and 0 mm represents no itch, and 100 mm represents unbearable itch. Patients will rate the VAS (average VAS of facial itch in the past 24 hours), and a researcher will record the VAS once weekly, generally at the third weekly treatment. The mean weekly VAS of itch over weeks 1-6 will be calculated as the sum VAS of each week divided by the number of weeks assessed. |
| Baseline, week 6, week 18, week 30 |
| The change of the Visual Analogue Scale (VAS) for facial lesion pain from baseline. | Visual Analogue Scale (VAS)VAS uses a 100-mm line that is labeled at each end, and 0 mm represents no pain, and 100 mm represents unbearable pain. Patients will rate the VAS (average VAS of facial pain in the past 24 hours), and a researcher will record the VAS once weekly, generally at the third weekly treatment. The mean weekly VAS of pain over weeks 1-6 will be calculated as the sum VAS of each week divided by the number of weeks assessed. | Baseline, week 6, week 18, week 30 |
| The change of the Total Lesion Count (TLC) on the face from baseline. | TLC is the sum of the inflammatory and non-inflammatory counts, including comedones, papules and pustules, nodules and cysts. | Baseline, week 6, week 18, week 30 |
| The change of the Inflammatory Lesions (IN) on the face from baseline. | IN is the sum of papules, pustules, nodules and cysts. | Baseline, week 6, week 18, week 30 |
| The change of the Skindex-16 dermatologic survey score from baseline. | Skindex-16 is a dermatologic quality-of-life survey. There are 16 questions in this survey. It concerns the skin condition which has bothered the patient the most during the past week. This survey calculated from 3 aspects including symptoms, emotions and functions. The score of each question is 0 to 6 points, and multiply by 16.6667，and get the sum of 16 questions' score. The average of the sum of 16 questions' score is the final result of skindex-16 dermatology survey. When the score is higher, it means the disease has greater influence on the patient. | Baseline, week 6, week 18, week 30 |
| 26897386 | Background | Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, Baldwin HE, Berson DS, Bowe WP, Graber EM, Harper JC, Kang S, Keri JE, Leyden JJ, Reynolds RV, Silverberg NB, Stein Gold LF, Tollefson MM, Weiss JS, Dolan NC, Sagan AA, Stern M, Boyer KM, Bhushan R. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016 May;74(5):945-73.e33. doi: 10.1016/j.jaad.2015.12.037. Epub 2016 Feb 17. |
| 22033354 | Background | Jung JY, Hong JS, Ahn CH, Yoon JY, Kwon HH, Suh DH. Prospective randomized controlled clinical and histopathological study of acne vulgaris treated with dual mode of quasi-long pulse and Q-switched 1064-nm Nd:YAG laser assisted with a topically applied carbon suspension. J Am Acad Dermatol. 2012 Apr;66(4):626-33. doi: 10.1016/j.jaad.2011.08.031. Epub 2011 Oct 26. |
| 20645525 | Background | Eichenfield LF, Jarratt M, Schlessinger J, Kempers S, Manna V, Hwa J, Liu Y, Graeber M; Adapalene Lotion Study Group. Adapalene 0.1% lotion in the treatment of acne vulgaris: results from two placebo-controlled, multicenter, randomized double-blind, clinical studies. J Drugs Dermatol. 2010 Jun;9(6):639-46. |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided