Atopic dermatitis
Conditions
Interventions
control group:symptomatic treatment
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Patients aged from 18 to 75 years old; 2. Meet the diagnostic criteria for moderate to severe atopic dermatitis (according to the Hanifin-Rajka criteria); 1) Chronic AD symptoms were present at least 3 years before baseline and subjects met Hanifin and Rajka criteria. 2) Subjects combined all of the following disease activity criteria: EASI score =16 at screening and baseline visit; vIGA-AD score =3 at screening and baseline visit - body surface area affected by AD (BAS) =10% at screening and baseline visit Weekly mean daily worst pruritus Numerical Rating Scale (NRS) =4 Note: The baseline weekly mean of the daily worst pruritus will be calculated from the 7 consecutive days prior to the baseline visit. A minimum of 4 scores per day was required over 7 days. 3) Subjects used topical emollients (moisturizers) twice daily for at least 7 days before the baseline visit. Note: Subjects may continue using prescription moisturizers or moisturizers containing ceramide, urea, filagolin degradation products, or hyaluronic acid prior to screening. 3. Previous and concomitant therapies 1) no previous exposure to any latent myofascial trigger point or myofascial trigger point injection; 2) no previous exposure to other treatments using myofascial trigger points or latent myofascial trigger points as treatment points, including but not limited to dry needling therapy, wet needling therapy, small needle-knife therapy, ozone injection and radiofrequency thermocoagulation therapy, transcutaneous electrical nerve stimulation, shock wave, traditional Chinese medicine fumigation, massage, thread-embedding, etc. 3) Subjects must not have more than 30% surface involvement of AD lesions at baseline that cannot be safely treated with moderate or high efficacy TCI (e.g., areas of skin atrophy, face, groin, trigone). 4) Subjects must not use the following AD treatments at the indicated times prior to the baseline visit: ? Systemic treatment of AD, including but not limited to corticosteroid, methotrexate, cyclosporine, azathioprine, phosphodiesterase 4 (PDE4) inhibitors, interferon-y, and mycophenolate mofetil within 4 weeks; ? Targeted biological therapy: within 5 half-lives or 12 weeks, whichever is longer; (3) Phototherapy, laser therapy, tanning rooms or prolonged exposure to sunlight may affect disease severity or interfere with disease assessment within 4 weeks; ? Oral or injection of traditional Chinese medicine within 4 weeks; ?Topical treatment (other than topical emollient treatment) including but not limited to TCS, TCI or topical PDE4-inhibitors within 7 days.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Age 75 years old; 2. Dermatitis caused by other causes; 3. Long-term use of corticosteroids or immunosuppressants; 4. Allergy to study medication; 5. Pregnancy or lactation; 6. Cerebrovascular, pulmonary, hepatic, renal or severe cardiovascular diseases; 7. Patients refused informed consent or estimated poor compliance or difficulty in follow-up;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At week 16, the proportion of subjects with a reduction of at least 75% from baseline in the eczema Area and Severity Index (EASI 75) was measured.;Proportion of subjects achieving a score of 0 or 1 on the validated Investigator Global assessment of atopic Dermatitis (vIGA-AD) and decreasing at least two grades from baseline at week 16;; | — |
Secondary
| Measure | Time frame |
|---|---|
| For subjects with NRS=4 in the most severe pruritus at baseline, the proportion of subjects with NRS=4 in the most severe pruritus at week 16 was improved (decreased) compared with baseline.;Proportion of subjects achieving EASI 90 at week 16;;For subjects with NRS=4 in the most severe pruritus at baseline, the proportion of subjects with NRS=4 in the most severe pruritus at week 4 was improved (decreased) compared with baseline.;The proportion of subjects achieving EASI 75 at week 4;;The proportion of subjects achieving EASI 75 at week 2;;The proportion of subjects achieving EASI 90 at week 4;;The proportion of subjects achieving EASI 100 at week 16 in the latent myofascial trigger point injection group;;For subjects with NRS=4 in the most severe pruritus at baseline, the proportion of subjects with NRS=4 in the most severe pruritus at week 1 was improved (decreased) compared with baseline.; | — |
Countries
China
Contacts
Public ContactQi Feng
Qilu Hospital of Shandong University
Outcome results
None listed