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

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ClinicalTrials.gov Identifier: NCT02900131
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
In-Hwa Choi, Kyung Hee University Hospital at Gangdong

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: Jaungo Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Dose Finding Trial of Topical Jaungo Application in Atopic Dermatitis Patients: a Randomized, Double-blind, Placebo-controlled Study
Actual Study Start Date : September 19, 2016
Actual Primary Completion Date : March 16, 2017
Actual Study Completion Date : March 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: trial group 1
Participants will receive Jaungo and placebo once a day for three weeks.
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.
Other Name: Hanpoong Jaungo

Drug: 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.
Other Name: Jaungo placebo

Experimental: trial group 2
Participants will receive Jaungo twice a day for three weeks.
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.
Other Name: Hanpoong Jaungo

Placebo Comparator: control group
Participants will receive placebo twice a day for three weeks.
Drug: 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.
Other Name: Jaungo placebo




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Change from baseline in 'SCORing of Atopic Dermatitis (SCORAD)' [ Time Frame: Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2) ]
  2. Change from baseline in 'Transepidermal water loss (TEWL)' [ Time Frame: Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2) ]
  3. Change from baseline in 'Dermatology Life Quality Index (DLQI)' [ Time Frame: Visit2(scheduled within a week of baseline), Visit3(in 3 weeks after visit2) ]
  4. Change from baseline in 'Total IgE' [ Time Frame: Visit1, Visit3(in 3 weeks after visit2) ]
  5. The clinical phenotype evaluation system of atopic dermatitis [ Time Frame: Visit2(scheduled within a week of baseline) ]
    Evaluation based on the results of 'clinical phenotype evaluation system of atopic dermatitis' questionnaire

  6. Change from baseline in 'eosinophil count' [ Time Frame: Visit1, Visit3(in 3 weeks after visit2) ]
  7. Change from baseline in 'IL-17' [ Time Frame: Visit1, Visit3(in 3 weeks after visit2) ]
  8. Change from baseline in 'IL-22' [ Time Frame: Visit1, Visit3(in 3 weeks after visit2) ]
  9. Change from baseline in 'IFN-γ' [ Time Frame: Visit1, Visit3(in 3 weeks after visit2) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900131


Locations
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Korea, Republic of
Kyung Hee University Hospital
Seoul, Hoegi, Korea, Republic of
Sponsors and Collaborators
Kyung Hee University Hospital at Gangdong
Investigators
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Study Chair: Seong-Kyu Ko, KMD, PhD Kyunghee University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: In-Hwa Choi, Clinical Professor, Kyung Hee University Hospital at Gangdong
ClinicalTrials.gov Identifier: NCT02900131     History of Changes
Other Study ID Numbers: ISEE_2015_JWG
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases