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CompletedNCT02900131Updated Jun 1, 2017

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

A Phase 2 interventional study of Jaungo and Placebo in Dermatitis, Atopic, sponsored by Kyung Hee University Hospital at Gangdong. Completed at 1 site in Korea, Republic of. Open to participants aged 5 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-01.

Sponsored by Kyung Hee University Hospital at Gangdong · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
5 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dermatitis, Atopic
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 34 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Kyung Hee University Hospital at Gangdong is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

    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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    trial group 1

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

    Drug: Jaungo · Drug: Placebo

  • Experimental
    trial group 2

    Participants will receive Jaungo twice a day for three weeks.

    Drug: Jaungo

  • Placebo comparator
    control group

    Participants will receive placebo twice a day for three weeks.

    Drug: Placebo

Interventions

  • DrugJaungo

    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.

    Also known as: Hanpoong Jaungo

  • DrugPlacebo

    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.

    Also known as: Jaungo placebo

06

What researchers measure

Primary outcomes

  1. 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 outcomes

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

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

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

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

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

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

  4. Change from baseline in 'Total IgE'

    Time frame: Visit1, Visit3(in 3 weeks after visit2)

  5. The clinical phenotype evaluation system of atopic dermatitis

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

    Time frame: Visit2(scheduled within a week of baseline)

  6. Change from baseline in 'eosinophil count'

    Time frame: Visit1, Visit3(in 3 weeks after visit2)

  7. Change from baseline in 'IL-17'

    Time frame: Visit1, Visit3(in 3 weeks after visit2)

  8. Change from baseline in 'IL-22'

    Time frame: Visit1, Visit3(in 3 weeks after visit2)

  9. Change from baseline in 'IFN-γ'

    Time frame: Visit1, Visit3(in 3 weeks after visit2)

07

Study locations

1 site
  • Kyung Hee University Hospital
    Seoul, Hoegi, Korea, Republic of
08

References and documents

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. PubMed 28403910 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02900131
Lead sponsor
Kyung Hee University Hospital at Gangdong
Responsible party
In-Hwa Choi (Clinical Professor, Kyung Hee University Hospital at Gangdong) — Principal investigator
First posted
Sep 14, 2016
Start date
Sep 19, 2016
Primary completion
Mar 16, 2017
Completion
Mar 16, 2017
Last update
Jun 1, 2017

Study contacts

Seong-Kyu Ko, KMD, PhD
study chair · Kyunghee University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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