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

NCT02900131 | Completed Phase 2 DMC

• 1 other identifier: ISEE_2015_JWG
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (9)

• 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 '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)

Study Arms (3)

trial group 1

EXPERIMENTAL

Participants will receive Jaungo and placebo once a day for three weeks.

Drug: Jaungo; Drug: Placebo

trial group 2

EXPERIMENTAL

Participants will receive Jaungo twice a day for three weeks.

Drug: Jaungo

control group

PLACEBO COMPARATOR

Participants will receive placebo twice a day for three weeks.

Drug: Placebo

Interventions

Jaungo DRUG

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.

Also known as: Hanpoong Jaungo

trial group 1; trial group 2

Placebo DRUG

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.

Also known as: Jaungo placebo

control group; trial group 1

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Kyung Hee University Hospital at Gangdong: lead

Study Sites (1)

Kyung Hee University Hospital

Seoul, Hoegi, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28403910 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

jaungo

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Seong-Kyu Ko, KMD, PhD

  Kyunghee University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 14, 2016
• Study Start: September 19, 2016
• Primary Completion: March 16, 2017
• Study Completion: March 16, 2017
• Last Updated: June 1, 2017

Record last verified: 2017-05

Locations

KR (1)