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

Efficacy, Safety and Dose Finding Trial of Topical Jaungo Application in Atopic Dermatitis Patients: a Randomized, Double-blind, Placebo-controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: Jaungo; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Hoegi
    • Seoul, Hoegi, Korea, Republic of
      • Kyung Hee University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: trial group 1; Participants will receive Jaungo and placebo once a day for three weeks.	Drug: 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.; Other Names: Hanpoong Jaungo; 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.; Other Names: Jaungo placebo
Experimental: trial group 2; Participants will receive Jaungo twice a day for three weeks.	Drug: 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.; Other Names: Hanpoong Jaungo
Placebo Comparator: control group; Participants will receive placebo twice a day for three weeks.	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.; Other Names: Jaungo placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in 'Eczema area and severity index (EASI)'	Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in 'SCORing of Atopic Dermatitis (SCORAD)'		Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)
Change from baseline in 'Transepidermal water loss (TEWL)'		Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)
Change from baseline in 'Dermatology Life Quality Index (DLQI)'		Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)
Change from baseline in 'Total IgE'		Visit1, Visit3(in 3 weeks after visit2)
The clinical phenotype evaluation system of atopic dermatitis	Evaluation based on the results of 'clinical phenotype evaluation system of atopic dermatitis' questionnaire	Visit2(scheduled within a week of baseline)
Change from baseline in 'eosinophil count'		Visit1, Visit3(in 3 weeks after visit2)
Change from baseline in 'IL-17'		Visit1, Visit3(in 3 weeks after visit2)
Change from baseline in 'IL-22'		Visit1, Visit3(in 3 weeks after visit2)
Change from baseline in 'IFN-γ'		Visit1, Visit3(in 3 weeks after visit2)

Collaborators and Investigators

• Sponsor: Kyung Hee University Hospital at Gangdong
• Investigators: Study Chair: Seong-Kyu Ko, KMD, PhD, Kyunghee University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2016
• Primary Completion (Actual): March 16, 2017
• Study Completion (Actual): March 16, 2017

Study Registration Dates

• First Submitted: September 2, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 30, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic
• Other Study ID Numbers: ISEE_2015_JWG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED