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

NCT ID: NCT02900131

Last Updated: 2017-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-19
• Study Completion Date: 2017-03-16

Brief 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.

Detailed Description

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.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

trial group 1

Participants will receive Jaungo and placebo once a day for three weeks.

Group Type: EXPERIMENTAL

Jaungo

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

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.

trial group 2

Participants will receive Jaungo twice a day for three weeks.

Group Type: EXPERIMENTAL

Jaungo

Intervention Type: DRUG

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.

control group

Participants will receive placebo twice a day for three weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

Jaungo

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Other Intervention Names

Hanpoong Jaungo; Jaungo placebo

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role: lead

Responsible Party

In-Hwa Choi

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seong-Kyu Ko, KMD, PhD

Role: STUDY_CHAIR

Kyunghee University

Locations

Kyung Hee University Hospital

Seoul, Hoegi, South Korea

Countries

South Korea

References

Yun Y, Ko Y, Ahn JH, Jang BH, Kim K, Ko SG, Choi I. Topical application of Jaungo in atopic dermatitis patients: study protocol for a randomized, controlled trial. Trials. 2017 Apr 12;18(1):176. doi: 10.1186/s13063-017-1920-9.

Reference Type: DERIVED

PMID: 28403910 (View on PubMed)

Other Identifiers

ISEE_2015_JWG

Identifier Type: -

Identifier Source: org_study_id