Efficacy, Safety and Dose Finding Trial of Topical Jaungo Application in Atopic Dermatitis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy, Safety and Dose Finding Trial of Topical Jaungo Application in Atopic Dermatitis Patients: a Randomized, Double-blind, Placebo-controlled Study

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: Jaungo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of AD will be made according to the criteria of Hanifin and Rajka Age: 5 years to 65 years objective SCORAD ≦40, Diagnosis of Mild to Moderate Atopic Dermatitis (AD) Exoriation≥1, Lichenification≥1, Dryness≥1 or Exoriation+Lichenification+Dryness≥3 Participants who able to express intention Participants willing to provide written informed consent 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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trial group 1<br>Participants will receive Jaungo and placebo once a day for three weeks. | Drug: Jaungo<br>* 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.<br>* Other names: Hanpoong Jaungo;Drug: Placebo<br>* 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.<br>* Other names: Jaungo placebo;|
| Experimental: trial group 2<br>Participants will receive Jaungo twice a day for three weeks. | Drug: Jaungo<br>* 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.<br>* Other names: Hanpoong Jaungo;|
| Placebo Comparator: control group<br>Participants will receive placebo twice a day for three weeks. | Drug: Placebo<br>* 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.<br>* Other names: Jaungo placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |