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Atopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence. Complementary and alternative medical approaches have been employed to relieve symptoms of Atopic Dermatitis. We aim to establish basic clinical efficacy and safety data for Jaungo in patients with Atopic Dermatitis.
This study is a randomised, double blind, placebo-controlled, single-centre trial with three parallel arms (trial group 1, trial group 2, and control group). The diagnosis of Atopic Dermatitis will be made according to the criteria of Hanifin and Rajka. Participants will receive Jaungo or a placebo-drug for three weeks. Participants in trial group 1 will apply Jaungo and placebo to the lesion once a day for three weeks. Participants in trial group 2 will apply Jaungo to the lesion twice a day for three weeks. Participants in control group will apply placebo to the lesion twice a day for three weeks. Each participant will be examined for EASI (Eczema area and severity index), SCORAD (SCORing of Atopic Dermatitis), TEWL (Transepidermal water loss) and DLQI (Dermatology Life Quality Index) before and after applying medication. The outcomes to evaluate the maintenance of safety are Draize score, blood test and expert's opinion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trial group 1 | Experimental | Participants will receive Jaungo and placebo once a day for three weeks. |
|
| trial group 2 | Experimental | Participants will receive Jaungo twice a day for three weeks. |
|
| control group | Placebo Comparator | Participants will receive placebo twice a day for three weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaungo | Drug | Participants in trial group 1 will apply Jaungo and placebo to the lesion once a day for three weeks. Participants in trial group 2 will apply Jaungo to the lesion twice a day for three weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 'Eczema area and severity index (EASI)' | Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 'SCORing of Atopic Dermatitis (SCORAD)' | Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2) | |
| Change from baseline in 'Transepidermal water loss (TEWL)' | Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2) |
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Inclusion Criteria:
Exclusion Criteria:
Participants have oozing in the lesion
Users of following medications prior to trial periods
① Oral steroids, immunosuppressants and antibiotics within 4 weeks prior to this trial
② Topical steroids, immunosuppressants and antibiotics within 2 weeks prior to this trial
③ Light therapy within 2 weeks prior to this trial
④ Other medications thought to be inappropriate by researchers
Participants have severe burn or wide wound
Participants have oozing or ulcer in the lesion
Allergic reactions to Angelica gigas, Siebold et Zuccarini, sesame oil and lard
Participants have skin disease except atopic dermatitis
Participants have severe renal function disease (sCr > 2.0 mg/dL)
Participants have severe liver function disease (ALT, AST, ALP ≥ 2.5 × normal limits)
Participants have uncontrolled chronic diseases
Pregnancy, lactation
Participation in another clinical trial within one month of enrolment
Underlying disease or history of severe disease, abnormal state (paralysis; mental retardation other emotional or mental problems; diseases that can affect the absorption of drugs; no enough time to participate in this trial; visual disturbance and hearing impairment; inability to understand written consent or engage in this study)
Judgment by experts that the potential subject's participation is inappropriate.
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| Name | Affiliation | Role |
|---|---|---|
| Seong-Kyu Ko, KMD, PhD | Kyunghee University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital | Seoul | Hoegi | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28403910 | Derived | Yun Y, Ko Y, Ahn JH, Jang BH, Kim K, Ko SG, Choi I. Topical application of Jaungo in atopic dermatitis patients: study protocol for a randomized, controlled trial. Trials. 2017 Apr 12;18(1):176. doi: 10.1186/s13063-017-1920-9. |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C000626557 | jaungo |
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|
| Placebo | Drug | Participants in trial group 1 will apply Jaungo and placebo to the lesion once a day for three weeks. Participants in control group will apply placebo to the lesion twice a day for three weeks. |
|
|
| Change from baseline in 'Dermatology Life Quality Index (DLQI)' | Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2) |
| Change from baseline in 'Total IgE' | Visit1, Visit3(in 3 weeks after visit2) |
| The clinical phenotype evaluation system of atopic dermatitis | Evaluation based on the results of 'clinical phenotype evaluation system of atopic dermatitis' questionnaire | Visit2(scheduled within a week of baseline) |
| Change from baseline in 'eosinophil count' | Visit1, Visit3(in 3 weeks after visit2) |
| Change from baseline in 'IL-17' | Visit1, Visit3(in 3 weeks after visit2) |
| Change from baseline in 'IL-22' | Visit1, Visit3(in 3 weeks after visit2) |
| Change from baseline in 'IFN-γ' | Visit1, Visit3(in 3 weeks after visit2) |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |