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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
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 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.
Kyung Hee University Hospital
Seoul, Hoegi, South Korea
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)
Change from baseline in 'SCORing of Atopic Dermatitis (SCORAD)'
Time frame: Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)
Change from baseline in 'Transepidermal water loss (TEWL)'
Time frame: Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)
Change from baseline in 'Dermatology Life Quality Index (DLQI)'
Time frame: Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)
Change from baseline in 'Total IgE'
Time frame: Visit1, Visit3(in 3 weeks after visit2)
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)
Change from baseline in 'eosinophil count'
Time frame: Visit1, Visit3(in 3 weeks after visit2)
Change from baseline in 'IL-17'
Time frame: Visit1, Visit3(in 3 weeks after visit2)
Change from baseline in 'IL-22'
Time frame: Visit1, Visit3(in 3 weeks after visit2)
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Change from baseline in 'IFN-γ'
Time frame: Visit1, Visit3(in 3 weeks after visit2)