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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0002060

Enrollment

Registered

2016-09-13

Start date

2016-09-20

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 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). Participants in trial group 1 will

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
EASI (Eczema area and severity index)	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactJinhyang Ahn

Kyung Hee University Oriental Medicine Hospital at Gangdong

hyaji87@naver.com

Outcome results