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

Dermatitis, Atopic Clinical Trial

Official title:

Efficacy, Safety and Dose Finding Trial of Topical Jaungo Application in Atopic Dermatitis Patients: a Randomized, Double-blind, Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02900131
• Other study ID #: ISEE_2015_JWG
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2016
• Last updated: May 30, 2017
• Start date: September 19, 2016
• Est. completion date: March 16, 2017

Study information

• Verified date: May 2017
• Source: Kyung Hee University Hospital at Gangdong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 16, 2017
• Est. primary completion date: March 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 65 Years

Eligibility

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

? Oral steroids, immunosuppressants and antibiotics within 4 weeks prior to this trial

? Topical steroids, immunosuppressants and antibiotics within 2 weeks prior to this trial

? Light therapy within 2 weeks prior to this trial

? 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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital	Seoul	Hoegi

Sponsors (1)

Lead Sponsor	Collaborator
Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in 'Eczema area and severity index (EASI)'		Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)
Secondary	Change from baseline in 'SCORing of Atopic Dermatitis (SCORAD)'		Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)
Secondary	Change from baseline in 'Transepidermal water loss (TEWL)'		Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)
Secondary	Change from baseline in 'Dermatology Life Quality Index (DLQI)'		Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2)
Secondary	Change from baseline in 'Total IgE'		Visit1, Visit3(in 3 weeks after visit2)
Secondary	The clinical phenotype evaluation system of atopic dermatitis	Evaluation based on the results of 'clinical phenotype evaluation system of atopic dermatitis' questionnaire	Visit2(scheduled within a week of baseline)
Secondary	Change from baseline in 'eosinophil count'		Visit1, Visit3(in 3 weeks after visit2)
Secondary	Change from baseline in 'IL-17'		Visit1, Visit3(in 3 weeks after visit2)
Secondary	Change from baseline in 'IL-22'		Visit1, Visit3(in 3 weeks after visit2)
Secondary	Change from baseline in 'IFN-?'		Visit1, Visit3(in 3 weeks after visit2)