Dermatitis, Atopic
Conditions
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.
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.
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.
Sponsors
Kyung Hee University Hospital at Gangdong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 65 Years
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
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Visit2(scheduled within a week of baseline) | Evaluation based on the results of 'clinical phenotype evaluation system of atopic dermatitis' questionnaire |
| 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 '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) | — |
| Change from baseline in 'eosinophil count' | Visit1, Visit3(in 3 weeks after visit2) | — |
Countries
South Korea
Outcome results
None listed