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

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.

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.