Efficacy, safety and dose finding trial of topical Jaungo application in atopic dermatitis patients: a randomized, double-blind, placebo-controlled study

Not Applicable

Recruiting

• Conditions: Diseases of the skin and subcutaneous tissue

• Registration Number: KCT0002060
• Lead Sponsor: Kyung Hee University Oriental Medicine Hospital at Gangdong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1) The diagnosis of AD will be made according to the criteria of Hanifin and Rajka
2) Age: 5 years to 65 years
3) objective SCORAD ?40, Diagnosis of Mild to Moderate Atopic Dermatitis (AD)
4) Exoriation=1, Lichenification=1, Dryness=1 or Exoriation+Lichenification+Dryness=3
5) Participants who able to express intention
6) Participants willing to provide written informed consent

Exclusion Criteria

1) Participants have oozing in the lesion
2) Users of following medications prior to trial periods
? Oral steroids, immunosuppressants and antibiotics within 4 weeks prior to this trial
? Topical steroids, immunosuppressants and antibiotics within 2 weeks prior to this trial
? Light therapy within 2 weeks prior to this trial
? Other medications thought to be inappropriate by researchers
3) Participants have severe burn or wide wound
4) Participants have oozing or ulcer in the lesion
5) Allergic reactions to Angelica gigas, Siebold et Zuccarini, sesame oil and lard
6) Participants have skin disease except atopic dermatitis
7) Participants have severe renal function disease (sCr > 2.0 mg/dL)
8) Participants have severe liver function disease (ALT, AST, ALP = 2.5 × normal limits)
9) Participants have uncontrolled chronic diseases
10) Pregnancy, lactation
11) Participation in another clinical trial within one month of enrolment
12) 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)
13) Judgment by experts that the potential subject’s participation is inappropriate.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EASI (Eczema area and severity index)

Secondary Outcome Measures

Name	Time	Method
SCORAD (SCORing of Atopic Dermatitis);TEWL (Transepidermal water loss);DLQI (Dermatology Life Quality Index);Total IgE, eosinophil count, IL-17, IL-22, IFN-?;The clinical phenotype evaluation system of atopic dermatitis