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

• Status: Completed
• Trial end date: 2017-03-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kyung Hee University Hospital at Gangdong

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:

1. Participants have oozing in the lesion

2. 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

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.