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Dermatitis, AtopicPhase 2NCT02900131

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

A Phase 2 study testing Jaungo in people with Dermatitis, Atopic, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 5 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Dermatitis, Atopic
What is being tested?
Jaungo
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteSouth Korea
Study dates
19 Sep 2016to 16 Mar 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kyung Hee University Hospital

    Seoul, Hoegi

Other trials in South Korea

About this study

Official title: 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.

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.

Being tested
Jaungo, Placebo
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JaungoDrug

    Also called Hanpoong 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.

  • PlaceboDrug

    Also called Jaungo 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.

Study groups in NCT02900131
Study groupRoleWhat they receive
trial group 1ExperimentalParticipants will receive Jaungo and placebo once a day for three weeks.
Receives: Drug: Jaungo; Drug: Placebo
trial group 2ExperimentalParticipants will receive Jaungo twice a day for three weeks.
Receives: Drug: Jaungo
control groupPlacebo comparatorParticipants will receive placebo twice a day for three weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (9)

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

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

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

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

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

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

  4. Change from baseline in 'Total IgE'

    Measured: 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

    Measured: Visit2(scheduled within a week of baseline)

  6. Change from baseline in 'eosinophil count'

    Measured: Visit1, Visit3(in 3 weeks after visit2)

  7. Change from baseline in 'IL-17'

    Measured: Visit1, Visit3(in 3 weeks after visit2)

  8. Change from baseline in 'IL-22'

    Measured: Visit1, Visit3(in 3 weeks after visit2)

  9. Change from baseline in 'IFN-γ'

    Measured: Visit1, Visit3(in 3 weeks after visit2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2016 (estimated)
  2. Study start19 Sep 2016
  3. Primary completion16 Mar 2017
  4. Study completion16 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02900131
Sponsor's protocol ID
ISEE_2015_JWG
Status last verified
May 2017
First submitted
2 Sep 2016
Last updated
1 Jun 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Jaungo in people with Dermatitis, Atopic, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02900131, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.

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