Clinical trial NCT02900131: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 34
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in 'Eczema area and severity index (EASI)'
timeFrame: Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)
Secondary outcomes:
measure: Change from baseline in 'SCORing of Atopic Dermatitis (SCORAD)'
timeFrame: Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)
measure: Change from baseline in 'Transepidermal water loss (TEWL)'
timeFrame: Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)
measure: Change from baseline in 'Dermatology Life Quality Index (DLQI)'
timeFrame: Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)
measure: Change from baseline in 'Total IgE'
timeFrame: Visit1, Visit3(in 3 weeks after visit2)
measure: The clinical phenotype evaluation system of atopic dermatitis
timeFrame: Visit2(scheduled within a week of baseline)
measure: Change from baseline in 'eosinophil count'
timeFrame: Visit1, Visit3(in 3 weeks after visit2)
measure: Change from baseline in 'IL-17'
timeFrame: Visit1, Visit3(in 3 weeks after visit2)
measure: Change from baseline in 'IL-22'
timeFrame: Visit1, Visit3(in 3 weeks after visit2)
measure: Change from baseline in 'IFN-γ'
timeFrame: Visit1, Visit3(in 3 weeks after visit2)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
state: Hoegi
Study officials:
affiliation: Kyunghee University
name: Seong-Kyu Ko, KMD, PhD
role: STUDY_CHAIR
References:
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.