An interventional study of 3 times per week therapeutic frequency and 1 time per week therapeutic frequency in Acne Vulgaris, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Status unknown at 1 site in China. Open to participants aged 15 Years to 35 Years. Per ClinicalTrials.gov, last updated 2017-09-06.
Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
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.
750 studies on the registry are indexed under Acne Vulgaris; 89 are open to participants now.
This study's planned enrollment of 100 is above the median of 69 across 647 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 136 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
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.
1.Acupuncture: GV20, LU5, LI11, LI4,GV14,BL13, ST2, BL2,ST7,ST6 and ashi point on the face. * Huatuo Brand needle (0.20\*13mm) will be used for GV14, BL13, ST2, BL2, ST7, ST6 and ashi point on the face. Huatuo Brand needle (0.3\*40mm) will be used for GV20, LU5, LI11 and LI4. 2.Moving capping: Du Meridian (from GV14 to GV3) as well as the first (from BL11 to BL28) and second (from BL41 to BL53) side lines of the Urinary Bladder Meridian of Foot-Taiyang. * Guoyiyan Brand cupping jar (size 4) will be used. 3.Ear point tapping: Lung (CO14), Heart (CO15), Stomach (CO4), Neifenmi (CO18), Pizhixia (AT4). * Huatuo Brand, made by the seed of Vaccaria segetalis ( Neck.)Garcke.
Procedure: 3 times per week therapeutic frequency
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. 1. Acupuncture: GV20, LU5, LI11, LI4,GV14,BL13, ST2, BL2,ST7,ST6 and ashi point on the face. 2. Moving capping: Du Meridian (from GV14 to GV3) as well as the first (from BL11 to BL28) and second (from BL41 to BL53) side lines of the Urinary Bladder Meridian of Foot-Taiyang. 3. Ear point tapping: Lung (CO14), Heart (CO15), Stomach (CO4), Neifenmi (CO18), Pizhixia (AT4). * Use the seed of Vaccaria segetalis ( Neck.)Garcke.
Procedure: 1 time per week therapeutic frequency
Participants will receive acupuncture, moving cupping and ear-tapping procedure 3 times per week over the 6 weeks period.
Participants will receive acupuncture, moving cupping and ear-tapping procedure 1 time per week over the 6 weeks period.
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
Time frame: Baseline, week 1-6
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.
Time frame: Baseline, week 6, week 18, week 30
The change of the Visual Analogue Scale (VAS) for facial pruritus from baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 6, week 18, week 30
Plan to share: Undecided
Started Sep 2017 (actual). Primary completion is estimated for Dec 2019, 27 months after the start.
Of 61 non-industry interventional studies with no phase under Acne Vulgaris, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's planned 27 months is above that.
Counting every sponsor, half of 116 studies reached it within 9 months; a quarter within 4 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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