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

Primary Purpose

Dermatitis, Atopic

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Jaungo

Placebo

About this trial

This is an interventional treatment trial for Dermatitis, Atopic

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Participants have oozing in the lesion
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
Participants have severe burn or wide wound
Participants have oozing or ulcer in the lesion
Allergic reactions to Angelica gigas, Siebold et Zuccarini, sesame oil and lard
Participants have skin disease except atopic dermatitis
Participants have severe renal function disease (sCr > 2.0 mg/dL)
Participants have severe liver function disease (ALT, AST, ALP ≥ 2.5 × normal limits)
Participants have uncontrolled chronic diseases
Pregnancy, lactation
Participation in another clinical trial within one month of enrolment
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)
Judgment by experts that the potential subject's participation is inappropriate.

Sites / Locations

Kyung Hee University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

trial group 1

trial group 2

control group

Arm Description

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

Participants will receive Jaungo twice a day for three weeks.

Participants will receive placebo twice a day for three weeks.

Outcomes

Primary Outcome Measures

Change from baseline in 'Eczema area and severity index (EASI)'

Secondary Outcome Measures

Change from baseline in 'SCORing of Atopic Dermatitis (SCORAD)'

Change from baseline in 'Transepidermal water loss (TEWL)'

Change from baseline in 'Dermatology Life Quality Index (DLQI)'

Change from baseline in 'Total IgE'

The clinical phenotype evaluation system of atopic dermatitis

Evaluation based on the results of 'clinical phenotype evaluation system of atopic dermatitis' questionnaire

Change from baseline in 'eosinophil count'

Change from baseline in 'IL-17'

Change from baseline in 'IL-22'

Change from baseline in 'IFN-γ'

Full Information

NCT ID

NCT02900131

First Posted

September 2, 2016

Last Updated

May 30, 2017

Sponsor

Kyung Hee University Hospital at Gangdong

1. Study Identification

Unique Protocol Identification Number

NCT02900131

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

September 19, 2016 (Actual)

Primary Completion Date

March 16, 2017 (Actual)

Study Completion Date

March 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kyung Hee University Hospital at Gangdong

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

trial group 1

Arm Type

Experimental

Arm Description

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

Arm Title

trial group 2

Arm Type

Experimental

Arm Description

Participants will receive Jaungo twice a day for three weeks.

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

Participants will receive placebo twice a day for three weeks.

Intervention Type

Drug

Intervention Name(s)

Jaungo

Other Intervention Name(s)

Hanpoong Jaungo

Intervention Description

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

Intervention Name(s)

Placebo

Other Intervention Name(s)

Jaungo placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline in 'Eczema area and severity index (EASI)'

Time Frame

Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)

Secondary Outcome Measure Information:

Title

Change from baseline in 'SCORing of Atopic Dermatitis (SCORAD)'

Time Frame

Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)

Title

Change from baseline in 'Transepidermal water loss (TEWL)'

Time Frame

Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)

Title

Change from baseline in 'Dermatology Life Quality Index (DLQI)'

Time Frame

Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)

Title

Change from baseline in 'Total IgE'

Time Frame

Visit1, Visit3(in 3 weeks after visit2)

Title

The clinical phenotype evaluation system of atopic dermatitis

Description

Evaluation based on the results of 'clinical phenotype evaluation system of atopic dermatitis' questionnaire

Time Frame

Visit2(scheduled within a week of baseline)

Title

Change from baseline in 'eosinophil count'

Time Frame

Visit1, Visit3(in 3 weeks after visit2)

Title

Change from baseline in 'IL-17'

Time Frame

Visit1, Visit3(in 3 weeks after visit2)

Title

Change from baseline in 'IL-22'

Time Frame

Visit1, Visit3(in 3 weeks after visit2)

Title

Change from baseline in 'IFN-γ'

Time Frame

Visit1, Visit3(in 3 weeks after visit2)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The diagnosis of AD will be made according to the criteria of Hanifin and Rajka Age: 5 years to 65 years objective SCORAD ≦40, Diagnosis of Mild to Moderate Atopic Dermatitis (AD) Exoriation≥1, Lichenification≥1, Dryness≥1 or Exoriation+Lichenification+Dryness≥3 Participants who able to express intention Participants willing to provide written informed consent Exclusion Criteria: Participants have oozing in the lesion 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 Participants have severe burn or wide wound Participants have oozing or ulcer in the lesion Allergic reactions to Angelica gigas, Siebold et Zuccarini, sesame oil and lard Participants have skin disease except atopic dermatitis Participants have severe renal function disease (sCr > 2.0 mg/dL) Participants have severe liver function disease (ALT, AST, ALP ≥ 2.5 × normal limits) Participants have uncontrolled chronic diseases Pregnancy, lactation Participation in another clinical trial within one month of enrolment 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) Judgment by experts that the potential subject's participation is inappropriate.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seong-Kyu Ko, KMD, PhD

Organizational Affiliation

Kyunghee University

Official's Role

Study Chair

Facility Information:

Facility Name

Kyung Hee University Hospital

City

Seoul

State/Province

Hoegi

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28403910

Citation

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.

Results Reference

derived

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

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